177Lu-PSMA-617 for Prostate Cancer

Overseen By Bagi Jana, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: LHRH therapy

Must not be taking: Radiopharmaceuticals, PSMA therapy

Disqualifiers: Primary bone marrow disorder, Hematological disorders, Recent investigational study, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called 177Lu-PSMA-617, a targeted radioligand therapy, to assess its effects on prostate cancer that has spread and resists hormone therapy. It focuses on patients whose cancer has caused low blood cell counts due to bone marrow involvement. The goal is to understand the treatment’s clinical and biological effects on this specific type of prostate cancer. Men with metastatic castration-resistant prostate cancer, who have received prior treatment and have bone marrow involvement, might be suitable for this study. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in prostate cancer therapy.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you must not have received certain treatments like systemic therapy or radiation therapy recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that 177Lu-PSMA-617 is likely to be safe for humans?

Research has shown that 177Lu-PSMA-617 is generally well-tolerated by patients. Studies have found that this treatment can extend the lives of people with prostate cancer. In one study, patients who received 177Lu-PSMA-617 along with standard care lived longer and experienced slower disease progression compared to those who only received standard care.

Safety data from various studies indicate that the treatment's side effects are manageable. The most common issues reported are tiredness and dry mouth, which are usually mild and do not lead to discontinuation of the treatment. Long-term safety data are still being collected, but current results are encouraging.

Although the treatment is still under investigation, studies so far provide reassuring evidence about its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

177Lu-PSMA-617 is unique because it specifically targets prostate-specific membrane antigen (PSMA), which is commonly found on prostate cancer cells but not on most normal tissues. Unlike traditional treatments such as hormone therapy or chemotherapy, which can affect both cancerous and healthy cells, 177Lu-PSMA-617 uses a radioactive particle to deliver radiation directly to the cancer cells, minimizing damage to healthy tissues. Researchers are excited about this treatment because it represents a more precise approach to attacking prostate cancer, potentially leading to better outcomes with fewer side effects.

What evidence suggests that 177Lu-PSMA-617 might be an effective treatment for prostate cancer?

Studies have shown that 177Lu-PSMA-617 offers promising results for treating prostate cancer. Research indicates it can significantly reduce prostate-specific antigen (PSA) levels, with some patients experiencing a drop of at least 50%. This treatment has also improved scan results and reduced pain. Importantly, it typically exhibits low toxicity, causing fewer harmful side effects. These findings suggest that 177Lu-PSMA-617 could be an effective treatment option for prostate cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Bagi Jana, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread to the bone marrow, causing low blood counts. They must have had at least one prior systemic treatment, be on or agree to continue hormone-blocking treatments, and show a specific type of lesion on a PET scan. Participants need an ECOG performance status ≤2 (which means they can do some activities themselves), adequate kidney and liver function, and no other active cancers or serious medical conditions.

Inclusion Criteria

I've had at least one treatment for cancer that has spread, besides hormone therapy.

I have signed and understand the consent form for this study.

I am 18 years old or older.

Exclusion Criteria

I do not have any other cancers needing treatment, except for treated non-melanoma skin cancer.

I've had recent cancer treatment or am still dealing with its side effects.

Has known allergy or hypersensitivity to study drugs

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 177Lu-PSMA-617 for the treatment of mCRPC with bone marrow involvement and cytopenia

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 177Lu-PSMA-617

Trial Overview The study tests the effects of a radioactive drug called 177Lu-PSMA-617 in patients whose prostate cancer has spread to their bone marrow leading to low blood cell counts. The goal is to see how this drug impacts both the disease itself and the associated blood count issues.

How Is the Trial Designed?

Group I: SingleArm Experimental Treatment 1 Intervention

Treatment with 177Lu-PSMA-617

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40752988/

Outcomes for [ 177 Lu]Lu-PSMA-617 with and Without ... Key findings and limitations: Among 256 patients, 106 (41.4%) received an ARPI with [177Lu]Lu-PSMA-617. Those receiving an ARPI had lower ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2107322

Lutetium-177–PSMA-617 for Metastatic Castration ... This radioligand therapy has been associated with encouraging biochemical and radiographic response rates, reduced pain, and low toxicity in multiple early- ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251923

Outcomes of [177Lu] Lu-PSMA-617 Re-Treatment in ... Results: A total of 589 patients underwent [177Lu] Lu-PSMA-617 RLT, of whom 20 (3.4%, 20/589) received RLT retreatment. The median age was 71.3 ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.112

Outcomes for 177Lu-PSMA-617 with and without ... Patients receiving an ARPI with 177 Lu-PSMA-617 were more likely to complete all 6 cycles of treatment, but no clear differences in survival were observed on ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0302283824026083

A Meta-Analysis and Meta-Regression of the Efficacy ... In some studies, [177Lu]Lu-PSMA therapy has been shown to decrease the level of prostate-specific antigen (PSA) by at least 50%, with a favourable toxicity ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.TPS294

Long-term safety outcomes of 177Lu-PSMA-617 in patients ... It is important to further characterize long-term safety outcomes in 177 Lu-PSMA-617–treated patients, with particular regard to potential treatment-related ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251339

Comparative Safety and Efficacy of 177Lu-PSMA-617 and ... In this first comparative analysis of 177 Lu-PSMA-617 and 177 Lu-PSMA-I&T RLT in Taiwanese mCRPC patients, both agents demonstrated similar safety and efficacy.

8. annalsofoncology.org annalsofoncology.org/article/S0923-7534(25)00852-X/fulltext

Final overall survival and safety analyses of the phase III ... At the time of the final OS analysis, 299 deaths were reported in 142/234 participants (60.7%) in the 177Lu-PSMA-617 arm and 157/234 (67.1%) in ...