Category: News

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

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

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.

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."

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.

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.

Sean experienced pain relief 10 days after the 1^st RLT session with Actinium-225 PSMA and was able to get off the morphine medication. Hemoglobin and kidney values normalized after the 2^nd 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."

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.

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.

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).

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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-PSMA^HBED-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.

As many trials with ¹⁷⁷Lu-PSMA radioligand therapy (RLT) have demonstrated, a reduction of PSA of over 50% leads to statistically significant increase in overall survival. Our clinic’s results show the reproducibility of this data. After 3 sessions of ¹⁷⁷Lu-PSMA PSA decreases by an average of 68%. Preserving remissions and increasing quality of life of our patients remain our goals.

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 

We are thrilled and proud to share that our colleague Prof.Dr. Alexander Haug has been awarded The European Awards in Medicine 2022 in the field of nuclear medicine.

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.

TheraP, a phase II trial comparing radioligand treatment with ¹⁷⁷Lu-PSMA-617 to the chemotherapy using cabazitaxel was finalized with ¹⁷⁷Lu-PSMA demonstrating a clear advantage over the chemotherapy.

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.

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.

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 patients. This 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.

On 23 March 2021 Novartis announced positive results of the phase III trial with radioligand therapy ¹⁷⁷Lu-PSMA-617 in patients with castrate-resistant metastatic prostate cancer (mCRPC) after taxane chemotherapy and several androgen deprivation therapies (ADT).

Frontiers in Urology

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.

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”.

Markus Hartenbach wins Oncology Council's Young Investigator Award of the North American Association of Nuclear Medicine.