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Patient’s Testimonial: Full Remission after ¹⁷⁷Lu-PSMA therapy

Patient's Testimonial: Full Remission after ¹⁷⁷Lu-PSMA therapy

Here is a testimonial of one of our patients:

"I would like to announce hereby to the world that the small private clinic Minute Medical in Vienna led by Professor Markus Hartenbach, an expert in Nuclear Medicine, is nothing but a giant in helping people in need of medical attention, proving the success of day-to-day practical application of the results of the latest cutting edge scientific medical research.

Dr. Hartenbach had the courage to go against the tide of dusty, stone age “one-size-fits-all-protocols” in the treatment of metastatic prostate cancer, as a humble service to diseased men, who otherwise would have ended up going through depraving and for the human body harmful and often intolerable treatments that would result in the deterioration of the quality of life of people exposed to those treatments.

What are we talking about? The PSMA directed Lutetium-177 ligand therapy for metastatic prostate cancer, which is normally tough or impossible to access. According to my experience, most international doctors follow a “Protocol”, where affected people should rather be exposed to overall abdominal radiation, chemotherapy and years of chemical castration through hormone therapy, which often leads to the building of hormone-resistant cancer cells that cannot be treated any more and the patient is basically left to spend the rest of his life with the spreading cancer in his body. Not to mention the side effects caused by non-focussed radiation, by chemo, not to mention the hardly tolerable effects of hormone therapy.

Prof. Hartenbach is serving his patients by the motto of “individualized, tailor-made treatments”, meaning that he has the courage to apply the suitable most modern treatments at the right time to his patients. As is usual in a private clinic, however these are patients who are striving to receive this treatments at their own cost and possible peril, because they aim to maintain their lifestyle, their ability to enjoy life and their mobility despite their horrible disease, which, to my opinion, under normal “protocol” is made intolerable for the human body, slowly destroying everything in their lives that’s worth living for.

 

I’ve been writing this predominantly in third person till now, to give a somewhat objective report on the case. However, and unfortunately for me, I’m also subjected to this disease, and I went through a long process to find Prof. Hartenbach’s clinic and ask him to treat me. My name is Dr. Sandor Ambrus and I’m 70 years of age.

I can really call myself lucky to have been advised, and therefore being eternally grateful, to my wonderful and widely, as well as deeply, educated family doctor and General Practitioner who is up to date in the latest groundbreaking technologies, Dr. Andrea Szelenyi of Budapest, Hungary, who called my attention to the existence of this special therapy. I am also grateful to Prof. Stefan Förster who is heading up the Bayreuth University Clinic, who could not treat me because of the compulsory “Protocol” in public clinics, that is still controlling the medical practice in Germany. But he was kind enough to introduce me to Prof. Hartenbach and his team, who were able to “tailor-made” adapt the therapeutic approach according to my individual requirements in his above mentioned clinic “Minute Medical” to serve the ones in need with his top-notch treatment.

I had a drastic prostatectomy in January of this year (2024) in Budapest, Hungary, and was diagnosed after the surgery with further lymph nodes that were affected by metastases. I had a PSMA PET Scan that was showing the affected nodes. According to Hungarian “Protocol” – the same as the German one I was advised to go through the above-mentioned treatments, which filled me with a dread that induced sleepless nights, but even worse, horrible nightmares in the night to be awaken by the reality that was even more frightening than those scary dreams. This situation lasted till the moment I met Prof. Hartenbach who encouraged me to have the freedom of choice for my own body.

I had three Lutetium therapies in a row with a month between them. Each treatment took 15 minutes and a pleasant and educational conversation with Prof. Hartenbach regarding my health situation and the outlooks I may have. I have not experienced any side effects whatsoever then and since. After finishing the treatment, I had a repeated PSMA PET Scan that showed the complete remission of the cancer. This may obviously change with time, as you can never know with this disease, but I’m hoping that it would remain like this for a long time. In the worst case scenario that it reappears some time down the line, one can eventually repeat the treatment, depending on the circumstances at the time.

As for my current situation, I live my life to its full extent like before I was diagnosed with the disease. I’m as mobile as I have always been in the past fifty years, working in my business, having a beautiful family life and flying at least once a week within Europe and several times a year overseas. I’m driving tens of thousands of kms a year, and none of this has changed since I made up my mind to see Prof. Hartenbach.

Sincerely,

Dr. Sandor Z. Ambrus"

EANM24: The Age of Theranostics is NOW

EANM '24

The Age of Theranostics is NOW

You can listen to this article.

 

The European Association of Nuclear Medicine (EANM) hosted its annual conference, EANM24, from October 19-22, 2024, in Hamburg, Germany. EANM conferences are known for showcasing advancements in nuclear medicine, which can be broadly categorized into key areas:

  • New Targets: Identification of novel proteins and enzymes in different cancers and lesions
  • Novel Ligands: Development of transport molecules with enhanced binding capabilities
  • New Tracers: better more potent radionuclides with a more limited radiation radius to minimize the damage to the surrounding healthy cells
  • Expanded Applications of Known Radioligands: discovery of known proteins / enzymes in other cancers and lesions.

As usual during such professional get-togethers, this year’s conference also focused on how to bring theranostics to patients, addressing technical issues such as clinic setups, doctor training, patient flow, and enhancing the “last mile” delivery. Notably, one presentation from Finland examined the feasibility of outpatient theranostic treatment—something our clinic has been a shining example of. 1

Streamlining and unifying EU-wide regulations would further improve patient access to nuclear medicine therapies, with Austria providing a strong model for efficient practice.

AI and Nuclear Medicine

Artificial intelligence was a prominent topic, with discussions on AI’s potential to enhance nuclear medicine, for example, in interpreting PET scans. AI's ability to improve diagnostics could represent a substantial advancement in accuracy and efficiency.

Applications of PSMA- and DOTATATE-Based Theranostics

PSMA and DOTATATE-based imaging and therapy have become standard-of-care, with over a decade of clinical experience now guiding the development of new tracers and targets, such as FAP. A major theme was expanding PSMA therapy to earlier stages of prostate cancer and addressing resistance issues by shortening treatment intervals — a protocol our clinic has pioneered. Our streamlined protocol consists of three sessions with four-week intervals in contrast to the usual six to eight based on the research of our chief nuclear specialist Prof. Dr. Hartenbach. This regimen reduces cancer’s adaptive potential, yet still remaining tolerable for patients.

The revolutionary impact of PSMA PET/CT in clinical decision-making is being reaffirmed, with numerous studies corroborating its value in improving diagnosis and survival outcomes.2

New research on somatostatin receptors in myelomas and PSMA enzymes in gliomas holds promise for treating these cancers with targeted radionuclide therapy.3

New Targets

Approximately one-third of prostate cancers are PSMA-negative and do not respond to PSMA theranostics, requiring alternative markers. One study revealed high CD13 positivity in PSMA-negative prostate cancer, suggesting the protein CD13 as a viable target for theranostics.4

Emerging Radioligands and Radionuclides

New developments in radioligands include the DOTA-LM3, labelled with 161Terbium ([161Tb]Tb-DOTA-LM3), which demonstrated a seven-fold increase in tumor absorption compared to [177Lu]Lu-DOTATOC due to its superior two binding points.5

Terbium-161 as such also emerged as a promising radionuclide alternative to an often scarce Lutetium-177. 161Tb offers more concentrated radiation while maintaining favorable biodistribution. This radionuclide emits β- radiation similar to Lutetium-177, while also emitting therapeutically active very short range effective conversion electrons and auger electrons in combination with its low energy γ-ray emission, allowing for imaging via Single Photon Emission Computed Tomography (SPECT).6

Fibroblast Activation Proteins (FAPi)

FAPi warrants special attention. These proteins, characteristic of inflamed fibrous tissues, have been discovered in the microenvironment of most solid tumors, presenting a promising avenue for a universal therapy in stromal cancers. Stroma plays a critical role in cancer proliferation by nurturing tumors and shielding them from the body’s immune response. The oncological reality, however, is vastly more complex and heterogeneous. While FAPi-based imaging has shown success, therapeutic applications continue to face challenges related to suitable ligands.

 

These highlights only scratch the surface of the knowledge shared at EANM24. We will delve deeper into select topics and studies in upcoming publications, focusing on those most relevant to our patient cohort.

 

From EANM ’24 Abstract Book

1 OP-093 “Establishing a 177Lu-PSMA treatment site in an oncology outpatient day-ward”, T. Noponen, A. Saikkonen, L. Kääriä, M. Seppänen, K. Mattila, A. Ålgars

2 OP-423 “PSMA-PET and PROMISE re-define stage and risk in prostate cancer patients”, M. Karpinski, J. Hüsing, K. Claassen, L. Möller, H. Kajüter, F. Oesterling, V. Grünwald, L. Umutlu, H. Lanzafame, T. Telli, A. Merkel-Jens, A. Hüsing, C. Kesch, K. Herrmann, A. Stang, B. Hadaschik, W. P. Fendle

3 OP-359 “Assessing the theranostic potential of SSTR imaging in advanced multiple myeloma patients - the SCARLET trial”, W. Delbart, I. Karfis, M. Vercruyssen, S. Vercauteren, Z. Wimana, N. Meuleman, P. Flamen, E. Woff
OP-514 “First-In-Human Experience of Peptide Receptor Radionuclide Therapy with 177Lu-DOTATATE in Patients with Advanced Multiple Myeloma”, W. Delbart, I. Karfis, M. Vercruyssen, S. Vercauteren, Z. Wimana, N. Meuleman, P. Flamen, E. Woff
EP-0113 “Diagnostic utility of 68Ga-Prostate-Specific Membrane Antigen-11 PET/CT in glioma recurrence - a prospective analysis”, A. Meena, K. Subramanian, R. Kumar, H. Singh, B. Mittal
EP-0653 “68Ga/177Lu-PSMA theranostics in recurrent high-grade glioma - First study results & future perspectives”, A. Karlberg, B. E. Vindstad, E. M. Berntsen, H. Johansen, T.M. Keil, O. Solheim, S. Kjærnes Øen, T. Skeidsvoll Solheim, L.Eikenes

4 OP-424 “CD13 as a Potential Membrane Marker in PSMA-Negative Prostate Cancer: A Complementary or Superior Alternative to PSMA”, Y. Tang, L. Xiao, J. Yang, J. Hou, J. Hong, A. Rominger, K. Shi, S. Hu

5 OP-252 “Therapy with the somatostatin receptor antagonist DOTA-LM3 labeled with terbium-161: Interim results of the Phase 0 Study in patients with gastroenteropancreatic neuroendocrine tumors”, J. Fricke, F. Westerbergh, L. McDougall, C. Favaretto, E. Christ, G. Nicolas, S. Geistlich, F. Borgna, M. Fani, P. Bernhardt, N. van der Meulen, C. Müller, R. Schibli, D. Wild

6 OP-515 “When Lutetium-177 DOTATATE Is Not Available: Insights Into Use of Terbium-161 in the Treatment of Metastatic Paraganglioma”, N. Jacobs, O. Kolade, K. Hlongwa, S. More
OP-529 “Mixed-LET 161Tb-ART-101 radiopharmaceutical enhances therapeutic responses in advanced prostate cancer”, M. Bio Idrissou, J. Tromp, H. Comas Rojas, L. Lambert, A.
Pinchuk, Y. Medina, A. Carston, R. Hernandez
OP-532 “Development of [161Tb]Tb-DOTA-HYNIC-panPSMA for targeted radionuclide therapy of prostate cancer”, C. Morgat, D. Vimont, K. Attia

UpFrontPSMA Trial Results: PSMA Therapy Advances to the Frontlines of Prostate Cancer Treatment

UpFrontPSMA Trial Results: PSMA Therapy Advances to the Frontlines of Prostate Cancer Treatment

The results of the UpFrontPSMA trial are in, unveiled during the ESMO 2024 in Barcelona, and they are truly encouraging for the future of prostate cancer treatment. 177Lu-PSMA radioligand therapy (RLT) has taken a significant leap forward in the treatment protocol, now positioning ahead of docetaxel chemotherapy. Initially introduced after the VISION trial as a last-in-line therapy for advanced metastatic castration-resistant prostate cancer in heavily pre-treated patients, this RLT has shown remarkable efficacy and a favorable safety profile, allowing it to move closer to the forefront of treatment options. In fact, it seems like the earlier, the more effective it is.

Trial Overview

The UpFrontPSMA phase 2 trial evaluated the efficacy of administering 177Lu-PSMA prior to docetaxel compared to docetaxel alone in patients newly diagnosed with high-volume metastatic hormone-sensitive prostate cancer (mHSPC). The experimental group received two cycles of 177Lu-PSMA (7.5 GBq each) followed by six cycles of docetaxel, while the control group received only docetaxel. The primary endpoint[1] was achieving undetectable prostate-specific antigen (PSA) levels after 48 weeks—a high bar for success.

Participant Selection Criteria

The most critical selection criterion for the trial was high PSMA uptake, with patients requiring a SUVmax above 20 based on 68Ga-PSMA PET/CT scans. (As researchers reported, some patients had to be excluded despite having initially demonstrated PSMA-avid lesions. This exclusion occurred because androgen deprivation therapy (ADT) prior to treatment led to downregulation of PSMA expression.)

Adverse Events

The combination of 177Lu-PSMA with docetaxel did not result in increased toxicity. The most common severe adverse events were the same in the two groups:

  • febrile neutropenia (11% in the combination experimental group vs. 10% in the docetaxel-alone control group) and
  • diarrhoea (6% in the combination group vs. none in the control group).

The only adverse event that was different in the experimental arm was dry mouth, a known common side effect of the 177Lu-PSMA. But even this one was all grade 1, so very mild.

Being a targeted therapy, 177Lu-PSMA was well tolerated with fewer side effects, resulting in better quality of life (QoL). Unlike docetaxel, which caused a rapid decline in QoL, patients receiving 177Lu-PSMA maintained their well-being longer, with QoL dipping only after the introduction of docetaxel.

Protocol Considerations

There were some concerns about whether the experimental arm might have been underdosed, as only two cycles of 177Lu-PSMA were administered. Typically, three cycles are standard practice. However, the trial's design aimed to avoid delaying conventional docetaxel treatment.

As a side note, our clinic follows a stricter protocol, spacing the cycles four weeks apart and not the usual six to eight based on the research of Prof. Dr. Hartenbach, our leading specialist. In general, German university hospitals, having played a pivotal role in developing PSMA-targeted therapies in the early 2000s, have accumulated significant expertise in this area.

Results

The results of the trial were highly promising. 41% of patients in the 177Lu-PSMA plus docetaxel group achieved undetectable PSA levels at the 48-week mark, compared to just 16% in the docetaxel-alone group. This significant difference demonstrates the superior antitumor activity of administering 177Lu-PSMA therapy before docetaxel, without an increase in toxicity. These findings promise to trigger a change in the standard-of-care and introduce 177Lu-PSMA in the treatment of mHSPC at the very early stage.

 

[1] The predefined, primary goal of a clinical study, against which its success is measured

WARMTH Act: ²²⁵Ac-PSMA in treating metastatic castration-resistant prostate cancer

WARMTH Act: ²²⁵Ac-PSMA in treating metastatic castration-resistant prostate cancer

The WARMTH[*]-initiated multicentre retrospective study investigated the efficacy and safety of 225Ac-PSMA radioligand therapy (RLT) in treating metastatic castration-resistant prostate cancer (mCRPC). This study included 488 men from Australia, India, Germany, and South Africa, aged between 37 and 90. Most patients had previously undergone multiple treatments, including chemotherapy, androgen-axis-receptor inhibitors, or 177Lu-PSMA RLT.

 

The findings show that 73% of the patients experienced some PSA decline after at least one cycle of 225Ac-PSMA RLT, with 57% showing a decline of 50% or more. Despite common side effects like xerostomia and bone marrow toxicities (with a notable prevalence of impaired bone marrow observed before treatment initiation), the therapy was generally well-tolerated, even in patients with pre-existing conditions.

With the study being retrospective, 225Ac-PSMA RLT was frequently administered as a last-line intervention when all other options had been exhausted and proven ineffective.

A significant association was found between a PSA decline of at least 50%, absence of prior exposure to specific treatments, lack of certain metastases, and absence of anaemia at the initiation of 225Ac-PSMA RLT with extended both progression-free and overall survival. However, the number of treatment cycles did not correlate with improved progression-free survival or overall survival.

In conclusion, 225Ac-PSMA RLT demonstrated significant antitumor effects in mCRPC, even in individuals with compromised bone marrow and renal function. The impact of previous treatment history and metastatic burden on time to death or disease progression suggests that patients with a comparatively lower disease burden may derive greater benefit from 225Ac-PSMA RLT.

Our clinic has an established practice of offering our patients with a corresponding disease profile a combination therapy of 1 + 2 (one 225Ac-PSMA + two 177Lu-PSMA cycles). 

[*] WARMTH – World Association of Radiopharmaceutical & Molecular THerapy

Age, years
Mean 68·1 (8·8)
Range 37–90
Countries
Australia 57
India 111
Germany 72
South Africa 248
PSA at baseline, ng/mL
Median (IQR) 169·5 (34·6–519·8)
Previous treatment for mCRPC
Docetaxel 324 (66%)
Cabazitaxel 103 (21%)
Abiraterone 191 (39%)
Enzalutamide 188 (39%)
177Lu-PSMA RLT 154 (32%)
Radium-223 dichloride 18 (4%)
Pattern of disease
Bone metastases 435 (89%)
Lymph node metastases 352 (72%)
Visceral metastases 99 (20%)
Peritoneal metastases 8 (2%)

Transforming cancer from lethal to chronic. Therapy response after 2 cycles (6 sessions) of ¹⁷⁷Lu-PSMA therapy.

Transforming cancer from lethal to chronic. Therapy response after 2 cycles of ¹⁷⁷Lu-PSMA therapy

The case illustrates the scientific findings that the radioligand therapy 177Lu-PSMA is safe and effective and can be successfully applied more than once in case of recurrence, moving towards the goal of transforming cancer from lethal into a chronic disease like any other. It also grants the patients considerably better quality of life than the protracted ADT or chemotherapy.

72 y.o. patient William Daly was first diagnosed with prostate cancer (PC) in December 2021. Despite heavy pre-treatment with several cycles of immunotherapy, cryoablation and leukin therapy, the disease continued to progress extending to lymph nodes. Mr. Daly refused constant antihormonal therapy and chemotherapy due to side effects and opted for 177Lu-PSMA targeted radioligand therapy. The patient has undergone 2 cycles 3 infusions each of the therapy. After the first one, PC went into remission for 1,5 years.

BEFORE 1st cycle AFTER 1st cycle
PSMA PET/CT October 2021

PSA 45 ng/ml.

High PSMA-expressing lymph node metastases.

PSMA PET/CT April 2022

PSA 0,18 ng/ml.

After 3x 177Lu-PSMA therapy sessions from December 2021 to February 2022, significant remission of the retroperitoneal and locoregional lymph node metastases. PSA decline was documented until October 2022 with a Nadir of 2,39ng/ml.

BEFORE 2nd cycle AFTER 2nd cycle
PSMA PET/CT September 2023

PSA 23,3ng/ml

Progressive retroperitoneal lymph node disease with two new bone lesions as well as progression in the prostate.  3-session cycle of 177Lu-PSMA radioligand therapy is repeated 1,5 years after the first one. A short-term complimentary ADT with Relugolix was initiated along with the RLT to increase PSMA expression.

PSMA PET/CT April 2024

PSA 0,1 ng/ml

After 3x 177Lu-PSMA radioligand therapy sessions from December 2023 to February 2024 no activity in the metastases was detected in September 2023. The only side effect reported was short-term mild nausea and mild fatigue after the treatment. Meanwhile the patient stopped all medication and reports general well-being and regained strength.

 

Read Mr. Daly's story in his own words:

"My story began in December 2014 when I was diagnosed with prostate cancer (PC). It was identified as “intermediate risk” with a Gleason score of 7 (3+4) in 3 of the 12 biopsy samples taken. At this point it had not spread, but after an MRI, it showed an “extracapsular extension”. I chose not to have surgery and decided to do watchful waiting. I also wanted to stay away from hormone therapy.

After another MRI, it showed that the PC was very near the seminal vesicles and I engaged a doctor in Fort Lauderdale, Florida to help me with treatment. He performed a 3D mapping biopsy that showed Gleason 8 in the prostate. Then he treated the PC with focal cryoablation, and my PSA went from 9 to 0.6. This was done in October 2017.

The PSA stayed there for about 2 years before it began to gradually move up. As it happens, I was treated for a kidney stone in July of 2020 and a swollen lymph node was noted in my pelvis area. After another MRI, my doctor in Florida suggested that we go through immune therapy. His immune therapy was very successful in some of his patients – but I did not respond to it. It was at that time that we pursued the 177Lu-PSMA treatment with Dr. Hartenbach. First, I had a PSMA scan done in Houston, Texas to see if the treatment could be done at all. After approval, I made arrangements to go through the therapy with Dr. Hartenbach. My PSA was about 48 at that time. That was in the fall of 2021.

After 1 cycle (3 infusions) of the therapy, my PSA was 2.39. The follow-up PSMA scan showed a remarkable improvement. There were only a couple of places where the cancer was still in the process of dying. We were very pleased at the response. This was in the spring of 2022 and the therapy had given me 2 years of remission. After closely monitoring the PC with scheduled labs, the PSA began to move up again. When it reached 23, we felt more treatment would be beneficial.

So, in December of 2023 I started another cycle of the 177Lu-PSMA  therapy. We also added a drug called Orgovyx to the therapy. The PSMA scan was done in April after the treatment was completed in February 2024. I guess I can say that I experienced  minimal side effects from the treatment (some nausea for a couple of days and some “dry mouth”). So, all in all, I was treated with 2 cycles (6 actual infusions) by Dr. Hartenbach.

This time, the results of the treatment and scan were remarkable. The PSMA scan was clear and the report said I had a “complete response” to the therapy – my PSA is now 0.1. This couldn’t have been a better result and I was so grateful and blessed to have been working with Dr. Hartenbach and his staff. I am praying for a long - term remission.

Thanks again for Dr. Hartenbach and all his staff."

Breast Cancer Breakthrough: The First Theranostic Treatment with DOTATATE. A Game Changer?

Breast Cancer Breakthrough: The First Theranostic Treatment with DOTATATE. A Game Changer?

Recent research has found that somatostatin receptor type 2 (SSTR2) is overexpressed in certain types of breast cancer, particularly in estrogen receptor (ER) positive tumors. This discovery paves the way for the potential use of the well-established DOTATATE theranostics to improve the diagnosis and treatment of this type of breast cancer. A study involving both preclinical and phase 2 clinical trials demonstrated highly promising results.

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“This treatment has given me back my life.”

"This treatment has given me back my life."

Success story after 3 sessions of radioligand PSMA therapy with 1x Actinium-225 & 2x Lutetium-177

Sean Kenny was first diagnosed with prostate cancer in December 2020, when he just turned 51 y.o. Before landing in our clinic, he had undergone multiple treatments, including 6x Docetaxel, antihormonal therapy, immunotherapy and cryotherapy. He chose to pause ADT due to side effects but had to re-induct antihormonal therapy with Firmagon and Apalutamide mid-2023. The cancer was still progressing with an increasing bone involvement. Despite PSA response, pain and PSMA expression persisted. He was put on morphine medication for pain relief. His left hip was so badly damaged that it had to be replaced. After 3 years of back-and-forth Sean opted for PSMA targeted radioligand therapy (RLT) and experienced a remarkable recovery following just one 3-session cycle. Due to heavy bone infiltration, we recommended the first session be done with Actinium-225 and the two remaining - with Lutetium-177. Judge for yourself.

BEFORE

PSMA PET/CT December 2023

PSA 2 ng/ml after re-induction antihormonal and ARPI treatment. St.p. hip replacement to the left previously. Still high PSMA expressing bone metastases and pain under morphine medication.

AFTER

PSMA PET/CT April 2024

After 1x 225Ac and 2x 177Lu PSMA ligand therapy sessions from December 2023 to March 2024.

PSA 0,18 ng/ml. Minimal residual activity in the known bone lesions, most likely apoptotic cells. ALP down from 570U/l to 180U/l (norm <150).

Sean experienced pain relief 10 days after the 1st RLT session with Actinium-225 PSMA and was able to get off the morphine medication. Hemoglobin and kidney values normalized after the 2nd RLT session with Lutetium-177 PSMA. The only side effect he experienced was short-term mild nausea and mild fatigue after the treatment. At the time-point of the control PSMA PET/CT, these symptoms were gone. Sean reports general well-being and regained strength.

Here is the story in his own words:

"My story started back in December of 2020 when I was told that I had advanced prostate cancer, which had spread to my lymphatic system. This was picked up with a routine blood test when I turned 50 years of age and when they included the PSA as a blood marker. I did not have any obvious symptoms at the time and in fact I was still running 7-minute miles and was very active.

I was put on hormone treatment in January of 2021 after I came back from the Royal Marsden hospital in the UK where I got a PSMA scan (I could not get a scan in Ireland for 9 months). Later in 2021 I started a course of 6 x Chemo (Docetaxel) and then 4 weeks of RT. In early 2022 I came off the hormone treatment due to side effects (my PSA has gone to a very low figure). I got my life back again as I regained my energy, and my fatigue was a lot less.

Then in early 2023 my PSA started to slowly rise again, so we looked into travelling to the US to undergo immunotherapy and cryotherapy at a clinic. While waiting for this clinic to admit me I developed an intermittent pain in my left leg which I relayed to my oncologist during an outpatient visit. After immediate X-rays of my leg, I was told that I had an impending fracture of my femur and needed an emergency hip replacement (my pelvic bone was also diseased). My hip was replaced 2 days later, and when I was strong enough again, I went to America to undergo this procedure in the hope that it would put me into remission again. Unfortunately, this operation was not successful, and within a month of coming home the pain I was suffering in my leg area was unbearable due to the metastasis in my pelvic area. I was put straight back on hormone treatment again and was told that I would be also receiving RT again.

My good Wife Brid had been in touch with the American clinic looking to see if there were other options available. This was then when I was referred to Prof Hartenbach and the rest as they say is history. I’m off all pain medication and with the hopes of coming off both my hormone treatments in the near future. From there it will be active surveillance and fingers crossed, but certainly this treatment has given me back my life. 

Thank you, Prof. Hartenbach and team."

 

Harnessing Alpha Emitters in Radiopharmaceuticals for Cancer Treatment

Harnessing Alpha Emitters in Radiopharmaceuticals for Cancer Treatment

In the ever-evolving battle against cancer, the field of radiopharmaceuticals has emerged as a potent weapon, and alpha emitters such as actinium-225, astatine-211, and lead-212 are quickly gaining prominence. These alpha-emitting isotopes are revolutionizing cancer treatment, offering targeted therapy with the potential to eradicate malignant cells while minimizing damage to surrounding healthy tissue.

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Reimagining Treatment Timelines: ¹⁷⁷Lu-PSMA at Early Stages Ahead of Conventional Therapies

Reimagining Treatment Timelines: ¹⁷⁷Lu-PSMA at Early Stages Ahead of Conventional Therapies

Radioligand therapy (RLT) utilizing 177Lu-PSMA gained initial approval in the USA as a final recourse once all other treatment options have been exhausted. However, quite a few ongoing trials are exploring the potential for deploying this therapy earlier in the course of the disease due to its demonstrated safety, efficacy, and relatively low incidence of side effects. In fact, radioligand therapy is very safe. A recent study has demonstrated that even 6 sessions are very well tolerated, what makes this treatment a viable option as a recurring therapy in case of recurrence.

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¹⁷⁷Lu-DOTATATE in meningioma treatment

¹⁷⁷Lu-DOTATATE in meningioma treatment

Peptide receptor radionuclide therapy (PRRT) has significantly advanced in the last two decades within the realm of neuroendocrine tumours (NETs), leveraging the overexpression of somatostatin receptors characteristic of these tumours. This same receptor profile is also prevalent in nearly all meningiomas, with expression of somatostatin receptor 1 & 2 (SSTR1 / SSTR2), rendering PRRT a viable treatment option. Multiple studies have scrutinized the efficacy of PRRT (177Lu-DOTATATE) in meningioma patients, consistently demonstrating its effectiveness, particularly in prolonging progression-free survival (PFS).

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⁶⁸Ga-PSMA PET/CT – unlocking precision

Unlocking precision: the revolutionary impact of ⁶⁸Ga-PSMA PET/CT in prostate cancer care

 

In the realm of medical diagnostics, the groundbreaking procedure of 68Ga-PSMA PET/CT has emerged as a game-changer, offering unprecedented insights into the assessment and management of prostate cancer. Its extraordinary precision enables clinicians to visualize prostate cancer at a molecular level. It has revolutionized the diagnosis, staging, and personalized treatment strategies for prostate cancer, ultimately enhancing patient outcomes and reshaping the landscape of prostate cancer care. Below is the review of just some of the latest studies.

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Nuclear medicine – a versatile tool for treating many cancers

Nuclear medicine can help cancer patients live longer and enjoy a higher quality of life

Nuclear medicine is the fastest growing medical field, specifically in cancer treatment. It is extremely effective and low in side effects affording patients a prolonged and higher-quality life compared to conventional treatments like chemotherapy. It is also very versatile and applied in treatment of many cancer types. Our clinic not only provides cutting-edge therapies such as the radioligand PSMA therapy with 177Lu and 225Ac, as well as 177Lu-Dotatate therapy, but also offers the latest diagnostic procedure, 68Ga-FAPI PET/CT. Suitable especially well for such cancer types as breast, colon and pancreatic carcinomas, it represents a pioneering approach in diagnostic precision. Here you can learn more about FAPI in diagnostics.

 

¹⁷⁷Lu-PSMA is safe and effective for octogenarians

¹⁷⁷Lu-PSMA is safe and effective for octogenarians

A study evaluating the efficacy and safety of 177Lu-PSMA radioligand therapy for treating mCRPC in octogenarians demonstrated that radioligand therapy is safe and effective also in elderly patients. Moreover, patients who have not previously undergone chemotherapy had a better and longer-lasting response both in terms of overall and progression-free survival.

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¹⁷⁷Lu-PSMA RLT and SBRT combined

¹⁷⁷Lu-PSMA RLT and SBRT combined

The challenge of the radiation therapy in cancer treatment lies in achieving an optimal radiation level within tumours and metastases, effectively eradicating cancer cells while minimizing harm to surrounding healthy tissues. The combination of Stereotactic Body RadioTherapy (SBRT) and internal radioligand therapy (RLT) with 177Lu-PSMA appears to be precisely the way to maximize the treatment of oligometastatic prostate cancer.

A recent study demonstrated a remarkable increase in the median biologically effective dose (BED) to 159 Gy with the combined 177Lu-PSMA RLT and SBRT. Importantly, this was achieved without significant side effects, whereas standalone external radiation typically falls short of reaching 70Gy. SBRT, strategically applied post-RLT, precisely targets any remaining PSMA-positive metastases, as verified by a control PSMA PET/CT after RLT.

In collaboration with our partners specializing in Cyberknife, SBRT and proton/C-Ion-therapy, our clinic offers these advanced therapies in a coordinated approach. We are committed to providing our patients with the cutting-edge oncological treatment, ensuring the highest standards of care and precision in their fight against cancer.

⁶⁸Ga-FAPI superior to ¹⁸F-FDG

⁶⁸Ga-FAPI superior to ¹⁸F-FDG in Advanced Metastatic Pancreatic Cancer

Cancer operates insidiously, shaping a distinct microenvironment even before the emergence of actual cancer cells. This inherent challenge makes crucial early detection difficult. Enter the groundbreaking 'tracer,' designed to detect the FAP alpha receptor on cancer-associated fibroblasts (CAF). This innovative approach unveils the early fingerprints of cancer, akin to fingerprint powder, facilitating early diagnosis that significantly enhances therapeutic decision-making, as evidenced by the latest study.

In another noteworthy study, 68Ga-FAPI PET/CT proves its superiority over the conventional 18F-FDG in oncological diagnostics, especially for detecting metastases and local malignancy recurrence in advanced metastatic pancreatic cancer. The scans exhibit higher lesion intensity (SUV), underscoring the effectiveness of FAPI in targeting the microenvironment of solid tumors prevalent in sarcomas, breast, colon, and pancreatic cancers. Precise diagnostics translates to improved therapy decisions. Our clinic offers 68Ga-FAPI; contact us for a consultation and appointment.

Explore further details on FAPI diagnostics here.

Terbium-161

Radioligand therapy with Terbium-161

Radioligand PSMA therapy with the lutetium isotope 177Lu has proven to be very effective against metastatic prostate cancer. Nevertheless, there is still a share of patients who do not respond to this treatment. A possible reason may be insufficient radiation dose delivered to the cancer cells so that they are able to survive. So scientists are now experimenting with another isotope terbium-161 (161Tb) that emits a wider range of energies, namely conversion and Auger electrons next to beta radiation. It has decay properties similar to 177-Lutetium, half-life of about 7 days, but higher destructive power due to co-emission of conversion and Auger electrons. Their short radiation range allows it to release all their power directly in the cancer cells with almost no damage to the neighbouring healthy cells.

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PSMA PET/CT to assess the response to ARPI treatment (enzalutamide)

PSMA PET/CT to assess the response to Androgen Receptor Pathway Inhibitors (ARPI) treatment

PSMA PET/CT is the current mainstay diagnostic tool to stage prostate cancer, especially valuable if metastatic, and to decide on the right treatment (suitability of radioligand therapy 177Lu-PSMA). The newest study has established that it can also be used to evaluate the effectiveness of the treatment with Androgen Receptor Pathway Inhibitors (ARPIs).

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Radiopharmaceutical therapy moving up to earlier disease stages

Radiopharmaceutical therapy moving up to earlier disease stages

PSMAfore trial by Novartis (Phase III trial of 177Lu-PSMA-617 in taxane-naïve patients with mCRPC) has not only met its primary endpoint of radiographic progression-free survival (rPFS) but has shown amazing results with the potential to change the clinical practice, as presented at 2023 ESMO conference. Radioligand therapy (RLT) with 177Lu-PSMA-617 in pre-chemo patients brought about the median rPFS of 12 months compared to only 5,6 months in the control group under standard care. The radioligand treatment is also better tolerated with fewer grade 3 adverse effects. The results seem to demonstrate – the earlier in the course of the disease the RLT is applied, the more effective it is. Our own clinical practice certainly corroborates this in relevant cases.

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¹⁷⁷Lu-DOTATATE effective against G2 & G3 gastroenteropancreatic NETs

¹⁷⁷Lu-DOTATATE effective against G2 & G3 gastroenteropancreatic NETs

Although rare (orphan) and slow growing cancer type, some neuroendocrine tumors (NETs) are associated with rapid progression and poor prognosis. Original authorization for 177Lu-DOTATATE (Lutathera®) was based on the results of the NETTER-1 trial for inoperable midgut NETs. In the NETTER-2 trial 177Lu-DOTATATE has now also demonstrated its efficacy in patients with Grade 2 and 3 advanced gastroenteropancreatic NETs (GEP-NETs), and at that - as the first line treatment for newly diagnosed patients.

FAPI diagnostics

FAPI diagnostics

Fibroblast activation protein (FAP) is overexpressed in the tumor microenvironment or stroma of over 90% of solid tumors, what makes it a promising target for both therapeutic and molecular imaging applications. FAP-targeting molecular imaging has been quickly gaining steam in cancer diagnostics. It is especially useful for tumors with a strong desmoplastic (forming fibrous tissue) reaction, such as breast, colon, and pancreatic cancers.

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¹⁷⁷Lu-PSMA in taxane-naïve patients

Effectiveness of 177Lu-PSMA without prior chemotherapy

Since the end of the VISION trial that proved 177Lu-PSMA to be an effective treatment of metastasized prostate cancer, the next question arose – does it work even better if applied earlier in the course of the disease? An exciting study has now demonstrated that 177Lu-PSMA applied prior to chemotherapy is indeed more effective.

The metaanalysis was designed to evaluate the impact of prior taxane chemotherapy on response and survival in mCRPC patients after 177Lu-PSMA RLT.

It pooled together 13 studies comprising 2.068 patients. The results were:

  • Taxane-naïve patients had 1,82 times better odds of biochemical response, i.e. 1,8 higher chances of no PSA rise.
  • Taxane-naïve status was a predictor of both: significantly better progression-free survival (over 40%) and overall survival (over 46%).

Another clinical trial underway looks at the effectiveness of 177Lu-PSMA RLT in parallel with the anti-hormonal Androgen Deprivation Therapy. Results are expected in Q3 2024.

Personalized targeted radioligand therapy is complex and time-sensitive

Producing radioligands

Producing radioligands

Personalized targeted radioligand therapy is complex and time-sensitive

 

 

Manufacturing radioligands is an extremely complex and time-sensitive process, because radiopharmaceuticals need to be “delivered” directly to the cancer cells within days after being synthesized. This is what personalized targeted radionuclide therapy, a game-changer in oncology, is all about. Having our own laboratory and highly proficient radiochemists helps us serve our patients in-time and with the highest possible flexibility.

Hybrid imaging in prostate cancer diagnostics

Dual-Tracer PET-MRI-Derived Imaging Biomarkers for Prediction of Clinically Significant Prostate Cancer

Some prostate cancer cases will never develop metastases or any clinical symptoms and are defined as clinically insignificant. Accurate diagnosis able to differentiate between clinically significant and insignificant lesions leads to better disease management. The latest research of our working group has demonstrated that combined hybrid imaging using [18F] fluoromethylcholine (FMC) PET and [68Ga]Ga-PSMAHBED-CC conjugate 11 (PSMA)-PET achieved higher sensitivity for detecting clinically significant prostate cancer compared to multiparametric MRI alone. The PSMA PET is the leading method in this hybrid approach and is in fact more reliable than MRI alone.

Pluvicto® approval by EMA

Pluvicto® approval by EMA

Following FDA approval in March 2022, European Medicines Agency (EMA) also approved Pluvicto® (lutetium (177Lu) vipivotide tetraxetan) of Novartis in December 2022 for targeted radioligand treatment of progressive PSMA–positive metastatic castration-resistant prostate cancer. The EMA approval is based on the results from the Phase III VISION trial, in which “radioligand therapy with 177Lu-PSMA-617 prolonged radiographic progression-free survival and overall survival when added to standard care in patients with advanced PSMA-positive metastatic castration-resistant prostate cancer”[1]. Pluvicto® is to be used together with androgen deprivation therapy in adults previously treated with androgen receptor pathway inhibitors and taxanes. “The lutetium-177-PSMA was developed by the German Cancer Research Center (DKFZ) in cooperation with Heidelberg University Hospital and Heidelberg University.”[2]

[1] https://www.nejm.org/doi/full/10.1056/nejmoa2107322

[2] https://www.krebsinformationsdienst.de/aktuelles/2022/news059-metastasierter-prostatakrebs-zulassung-pluvicto-lutetium-177-psma-617-europa.php 

Interview with a patient

 

The patient A.G., 72 y.o., a molecular biologist himself, was diagnosed with metastatic prostate cancer in September 2018. After the conventional standard-of-care treatment (chemo- and antihormonal therapy) there were still residues of the primary tumour in the prostate, and lymph nodes and bone metastases. Up to date he has gone through 9 sessions (3 cycles) of 177Lu-PSMA therapy in the course of three years, initiating a new cycle once a routine control 68Ga-PSMA PET/CT detected PSMA expressing cancer lesions. The therapy has been extremely successful for A.G.: high response and hardly any side effects. Targeted radioligand therapy brings us much closer to the goal of making prostate cancer just another treatable chronic disease, at the same time preserving a decent quality of life, much like e.g. diabetes.

FAPi-based targeted theranostics for treating radioiodine-refractory differentiated thyroid cancer

FAPi-based targeted theranostics for treating radioiodine-refractory differentiated thyroid cancer

The study of FAPi-based lutetium-177 therapy in the All India Institute Of Medical Sciences in New Delhi was meant to investigate the therapeutic efficacy and safety of 177Lu-DOTAGA.(SA.FAPi)2 in RR-DTC patients. 15 heavily pre-treated (min 2 lines of prior treatment with lenvatinib and/or sorafenib) patients with the disease progression were selected based on FAPi PET/CT. An average of 3 sessions of 2 GBq each was administered in an 8-week interval.

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EAU updates its Prostate Cancer Guidelines

EAU updates its Prostate Cancer Guidelines

After the conclusion of the Vision trials the urological associations start gradually adjusting their Prostate Cancer guidelines, both in diagnostics and treatment. EAU now strongly recommends:

  • PSMA PET/CT (with gallium-68 or fluorine-18) as a more accurate diagnostic method than CT and bone scan for the staging of high-risk prostate cancer (PSA > 20 ng/mL, or GS > 7, or clinically palpable tumour in both lobes (cT2c)), and
  • 177Lu-PSMA as a therapy of choice for pre-treated (ADT) mCRPC patients with one or more metastatic lesions, highly expressing PSMA on the diagnostic radiolabelled PSMA PET/CT scan.

https://uroweb.org/guidelines/prostate-cancer/summary-of-changes

Both are available in our institution. Make your appointment now.

FAPI

Nuclear theranostics: what’s next?

While theranostics has immensely improved overall survival and quality of life of NET and prostate cancer patients and is increasingly becoming mainstream, the science is tirelessly working on the next big thing – pan-cancer theranostics based on fibroblast activation protein (FAP) found in the cancer-associated fibroblasts (CAF). With many widespread cancers in question, this would be truly revolutionary. First-in-human PET/CT studies of 68Ga-FAPI have demonstrated excellent results. A tracer derivative better suited for the therapeutical ends is within reach.

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Bone metastases, prostate cancer and theranostics

Bone metastases, prostate cancer and theranostics

Bone Metastases: A Common Secondary Cancer in Multiple Tumor Types

Bone metastases are a frequent complication in many cancer types, including breast (70%), prostate (85%), lung, and kidney cancers (40%), due to the unique characteristics of the bone microenvironment. Tumors predominantly metastasize to the axial skeleton—bones of the trunk and pelvis—rather than to the appendicular skeleton (limbs and girdles), following the distribution of red bone marrow.

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Ga-68 demonstrates superiority to F-18 in digital PSMA-PET/CT scans for staging prostate cancer

Gallium-68 has demonstrated superiority to Fluorine-18 in digital PSMA-PET/CT scans for staging prostate cancer

Fluorine-18 is a commonly used isotope utilized for conducting PSMA-PET/CT to stage prostate cancer, due to its longer half-life and higher production capacity as compared to Gallium-68. The latest study, however, has demonstrated superiority of Ga-68, because of the focal unspecific uptake of F-18 in the bones of ribs and pelvis. Without additional follow-up exams or any morphological correlates, this may be misinterpreted as bone metastasis. While nonspecific uptake in other tissues and physiologic uptake in the ganglia can be filtered out, unspecific bone uptake tends to lead to false interpretation and misdiagnosis. Bone metastases do occur in 10% of patients with the newly diagnosed prostate cancer, and 80-90% of patients in the advanced stage. Over-staging the patient may result in inadequate therapy decisions, especially in case of early biochemical recurrence. Read more.

PSMA therapy under more restrictive regimen of 4-week intervals

PSMA therapy under more restrictive regimen of 4-week intervals

How oft is the Lu-PSMA treatment conducted? The usual cycle consists of 3 sessions with 6 to 8 weeks interval in-between. Our more restrictive treatment regimen of 3 initial cycles with an interval of only 4 weeks in-between demonstrated >80% response rates even in heavily pre-treated patientsThis treatment does not care, “where” the metastases are: lymph nodes, bone, lungs, liver or even tumor in the prostate region itself. The usual “victims” of PSMA ligands, the salivary glands and kidneys, are not significantly affected under this regimen. Read more here.

Check other scientific investigations of our team on the topic.

PSMA therapy improves quality of life in prostate cancer patients

¹⁷⁷Lu-PSMA therapy improves health-related quality of life in patients with mCRPC

On Friday, 17 September 2021, Novartis announced further positive findings from the VISION trial: 177Lu-PSMA-617 therapy delays worsening of physical functioning and the onset of pain symptoms in patients with mCRPC. Hence, beyond extending overall survival and progress-free period, this Breakthrough Therapy also improves health-related quality of life. Read more

NCCN Guidelines add PSMA-PET imaging for prostate cancer

National Comprehensive Cancer Network, an alliance of cancer centers in the US, whose guidelines in oncology are applied to treating cancers, has added 68Ga-PSMA-PET imaging to its clinical practice guidelines for prostate cancer. Moreover, it recognized the high precision of this diagnostic tool as a primary stand-alone method and scrapped conventional imaging as a necessary prerequisite for PSMA-PET. Read more in the Urology Times.

Working group under Prof. Hartenbach shows outstanding diagnostic value of PSMA PET/MRI in prostate cancer

Working group headed by Prof. Markus Hartenbach was able to demonstrate the outstanding diagnostic value of PSMA PET / MRI in biopsy-proven prostate cancer. PSMA-PET/MRI can provide an accurate staging of newly diagnosed prostate cancer. In addition, treatment strategies were changed in almost a third of the patients due to the information of this hybrid imaging technique. The scientific paper was published in the Clinical Cancer Research journal.

 

Working group under Prof. Hartenbach MD demonstrates superiority of PSMA PET in diagnosing recurring prostate cancer

The working group headed by Prof. Markus Hartenbach MD was able to demonstrate the superiority of PSMA PET in the diagnosis of biochemical recurrence of prostate cancer, even at low PSA levels. Moreover, this diagnostic tool adds significant information to standard CT/MRI, changing treatment strategies in a significant number of patients. PSMA-positive lesions were detected in 85.5% patients, whereas 57.3% had no suspicious correlates according to the MRI or CT reports. Detection rates were 65% for a PSA value of 0.2 to <0.5 ng/ml, 85.7% for 0.5 to <1, 85.7% for 1 to <2 and 100% for ≥2. PSMA-PET changed therapeutic decisions in 74.6% of the patients (p < 0.001), with 86% of them being considered for metastases-directed therapies. The scientific paper was published in the “European Journal of Nuclear Medicine and Molecular Imaging”.