Lu-177-PSMA-617 for Prostate Cancer

Recruiting at 4 trial locations

Overseen By Nitin Yerram, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Hackensack Meridian Health

Must not be taking: Anticoagulants, Nephrotoxic drugs

Disqualifiers: Metastatic disease, Significant comorbidities, 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: 6

Duration: 12 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Lu-177-PSMA-617, a type of radioligand therapy, for men with high-risk prostate cancer. The goal is to evaluate the treatment's effectiveness in patients with a confirmed diagnosis and specific cancer characteristics who are eligible for surgery. Men may qualify if they have been diagnosed with high-risk prostate cancer and have a specific scan showing high PSMA levels in the prostate. Participants should not have received prior treatments such as hormone therapy or radiation to the prostate. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking nephrotoxic drugs (medications that can harm the kidneys), you may need to stop them due to the trial's kidney function requirements.

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

Research has shown that Lu-177-PSMA-617, also known as Pluvicto, holds promise for treating prostate cancer with manageable safety concerns. Studies indicate a low risk of severe side effects, which is encouraging. In previous studies, patients experienced less pain and showed positive responses.

Regarding safety, some side effects have been reported, but they are generally mild and typical for cancer treatments. Common issues include fatigue or dry mouth. Overall, many patients tolerate Lu-177-PSMA-617 well, making it a potentially safe option for those with prostate cancer. ^{1 2 3 4 5}

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

Lu-177-PSMA-617 is unique because it specifically targets the PSMA protein found on prostate cancer cells, delivering radiation directly to the cancer. Unlike traditional treatments like hormone therapy and chemotherapy, which can affect both cancerous and healthy cells, Lu-177-PSMA-617 aims to minimize damage to surrounding healthy tissue. This targeted approach not only has the potential to be more effective in shrinking tumors but may also result in fewer side effects, making it an exciting development for treating prostate cancer.

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

Research shows that Lu-177-PSMA-617, also known as PluvictoⓇ, yields promising results for treating prostate cancer. Participants in this trial will receive Lu-177-PSMA-617, which has been linked to significant improvements in progression-free survival and overall survival. One study found that Pluvicto™ reduced the risk of cancer worsening or death by 28% compared to standard care alone. Many patients receiving this treatment have shown positive responses, with a reduction in prostate-specific antigen (PSA) levels, often indicating decreased cancer activity. Overall, these findings suggest that Lu-177-PSMA-617 may effectively manage prostate cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Nitin Yerram, MD

Principal Investigator

Hackensack Meridian Health

Are You a Good Fit for This Trial?

This trial is for male adults with high-risk localized prostate cancer, as defined by NCCN guidelines. Participants must have a Gleason score of 8 or higher and a positive PSMA scan. They should be eligible for radical prostatectomy, which is the surgical removal of the prostate gland.

Inclusion Criteria

My prostate cancer is confirmed by a tissue test.

Patients with a life expectancy of greater than 10 years. Life expectancy can be estimated using specific tools and adjusted based on the clinician's assessment of overall health

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

My cancer has spread beyond the local lymph nodes.

My bone marrow does not function properly.

My liver does not work well.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at 6-week intervals before prostatectomy

12 weeks

2 visits (in-person)

Surgery

Radical prostatectomy with pelvic lymph node dissection is performed

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment and surgery

24 months

Visits at week 3, 6, 9, 11, 12, and every 3 months thereafter

What Are the Treatments Tested in This Trial?

Interventions

• Lu-177-PSMA-617

Trial Overview The trial is testing Lu-177-PSMA-617, a radiolabeled molecule that targets PSMA-positive cells in patients with high-risk localized prostate cancer before they undergo surgery to remove the prostate.

How Is the Trial Designed?

Group I: Lu-177-PSMA-617 Treatment Experimental Treatment 1 Intervention

Patients will receive 2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at the dose of 7.4 GBq (±10%), once every 6 weeks (±1 week)

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

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

Lombardi Comprehensive Cancer Center

Collaborator

Trials

8

Recruited

1,200+

Citations

1. 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- ...

2. novartis.com novartis.com/news/media-releases/psmaddition-data-show-novartis-pluvictotm-delays-progression-end-stage-prostate-cancer

PSMAddition data show Novartis Pluvicto™ delays ... PluvictoTM plus standard of care (ARPI + ADT) significantly reduced risk of progression or death by 28% (HR 0.72) versus SoC alone, ...

3. 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 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39327018/

Efficacy and Toxicity of [177Lu]Lu-PSMA-617 for Metastatic ... The phase 3 VISION trial demonstrated that [177Lu]Lu-PSMA-617 prolonged progression-free survival and overall survival (OS) in prostate-specific ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.83

Real-world clinical outcomes of patients treated with Lu ... During treatment, 21 (21%) patients achieved a PSA90 response, 51 (52%) patients achieved a PSA50 response and 60 (61%) patients achieved a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12399216/

Final overall survival and safety analyses of the phase III ... Overall, the results indicated that 177Lu-PSMA-617 is an effective alternative to ARPI change for second-line therapy in patients with mCRPC. We now present the ...

7. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14846-x

Adverse events associated with Lutetium-177-PSMA-617 ... Upon analyzing the demographic data, we discovered that reports containing weight information from 350 identified cases indicated a significant ...