Lutetium-177-PSMA-617 for Prostate Cancer

Overseen By Susan Cork Therapy Coordinator

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Ebrahim S Delpassand

Must be taking: Androgen receptor-axis-targeted therapy

Must not be taking: Radiopharmaceuticals, Chemotherapy

Disqualifiers: Renal impairment, CNS metastases, 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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 15

Duration: 36 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Pluvicto (Lutetium-177-PSMA-617) to determine its safety and effectiveness for men with a specific type of advanced prostate cancer that has spread to their bones. The focus is on those with a "super scan" pattern, where bone scans show significant activity. Although Pluvicto is already approved, it has not been tested on these patients before, so this study aims to address that gap. Men with prostate cancer that has spread and appears as a super scan on bone scans might be suitable for this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

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

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had systemic anti-cancer therapy within four weeks before the screening visit, and you cannot be on concurrent treatment with other chemotherapy, immunotherapy, or investigational therapy.

Is there any evidence suggesting that Lutetium-177-PSMA-617 (PLUVICTO) is likely to be safe for humans?

Research has shown that Lutetium-177-PSMA-617, also known as Pluvicto, is generally well-tolerated by patients with prostate cancer. Studies have found that this treatment often leads to positive results in lab tests and scans, reducing pain while keeping side effects minimal.

Most people using Pluvicto experience only mild side effects, such as fatigue or dry mouth, with serious issues being rare. The FDA has approved Pluvicto for treating prostate cancer, indicating its safety for this purpose.

Currently, limited information exists on how Pluvicto works in patients with a "super scan" pattern on bone scans. This study aims to address that by examining the safety and optimal dose for this group. ^{1 2 3 4 5}

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

Researchers are excited about Lutetium-177-PSMA-617 (PLUVICTO) because it offers a unique approach to treating prostate cancer. Unlike conventional treatments such as hormone therapy or chemotherapy, PLUVICTO is a radioligand therapy that specifically targets prostate-specific membrane antigen (PSMA) found on cancer cells. This targeting mechanism allows for precise delivery of radiation to cancer cells while sparing healthy tissue, potentially reducing side effects. The combination of selective targeting and the novel use of Lutetium-177 as a radioactive element makes PLUVICTO a promising option for more effectively managing prostate cancer.

What is the effectiveness track record for Lutetium-177-PSMA-617 in treating metastatic castration-resistant prostate cancer?

Research has shown that Lutetium-177-PSMA-617, also known as Pluvicto, holds promise for treating advanced prostate cancer that no longer responds to hormone therapy. Studies have found that many patients experience reduced cancer activity and pain. Pluvicto is generally safe, with few side effects, making it a viable option for many. In real-world use, patients taking Pluvicto alongside other treatments have achieved better results. Overall, it appears to help patients live longer, with an average survival of about 15.3 months after starting the therapy. These findings support its potential effectiveness, even though earlier major studies did not include patients with "super scans." ^{1 3 6 7 8}

Who Is on the Research Team?

Ebrahim S. Delpassand, M.D. Chairman & Medical Director, MD., Nuclear Medicine

Principal Investigator

Excel Diagnostics & Nuclear Oncology Center

Are You a Good Fit for This Trial?

Men over 18 with metastatic castration-resistant prostate cancer (mCRPC) and extensive bone metastases visible on a bone scan. They must have good performance status, adequate blood counts, normal kidney function, confirmed prostate cancer with PSMA-positive lesions, low testosterone levels due to treatment, and previous ARAT therapy. Excluded are those who've had recent radiopharmaceuticals or systemic anti-cancer therapies, hypersensitivity to PLUVICTO components, other ongoing treatments or malignancies affecting life expectancy.

Inclusion Criteria

Ability to understand and sign an informed consent form (ICF)

Hemoglobin ≥9.0 g/dL

Platelet count ≥90 × 10⁹/L

Exclusion Criteria

Plans to conceive or father a child during treatment and up to six months post-treatment

I haven't had cancer treatment in the last 4 weeks.

My kidney function is low, or I have low blood counts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six doses of Pluvicto, spaced every 6 ± 1 weeks, with dose escalation to determine the maximum tolerated dose

36 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with imaging and PSA checks

24 months

Every 3 months (imaging), monthly (PSA checks)

Long-term follow-up

Long-term follow-up for survival and safety every six months

Up to 5 years

Every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Lutetium-177-PSMA-617 (PLUVICTO)

Trial Overview The trial is testing the safety and optimal dosing of Lutetium-177-PSMA-617 (PLUVICTO) in up to 30 men with mCRPC showing a 'super scan' pattern of bone metastases. This study fills a knowledge gap left by prior trials that excluded such patients. Participants will receive an initial dose different from the standard as researchers seek the best dosage for this specific condition.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Ebrahim S Delpassand

Lead Sponsor

Trials

1

Recruited

140+

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37818966/

The real-world outcomes of Lutetium-177 PSMA-617 ... This study provides real-world evidence supporting the effectiveness and safety of Lu-177 PSMA-617 RLT in mCRPC patients, particularly when used in combination ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.82

Survival outcomes of patients (pts) with metastatic ... Characteristics and outcomes of patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with lutetium-177–PSMA-617 ( ...

4. 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 ...

5. urotoday.com urotoday.com/conference-highlights/asco-gu-2025/asco-gu-2025-prostate-cancer/158159-asco-gu-2025-patient-characteristics-and-overall-survival-with-lutetium-lu177-vipivotide-tetraxetan-177lu-psma-617-a-real-world-analysis-of-early-adopters.html

Patient characteristics and overall survival with lutetium ... The median overall survival from the start of ¹⁷⁷Lu-PSMA-617 therapy was 15.3 months (95% CI: 14.6–16.3), with 137 of 643 patients (21.3%) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12481865/

Adverse events associated with Lutetium-177-PSMA-617 ... Its high expression in prostate cancer, limited expression in normal tissues, and association with androgen independence, metastasis, and ...

7. 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, ...

8. jnm.snmjournals.org jnm.snmjournals.org/content/early/2025/09/25/jnumed.125.270704

First-Line [177Lu]Lu-PSMA-617 Therapy Without ADT ... The use of [177Lu]Lu-PSMA-617 before ADT for metastatic prostate cancer has been described in only a few published cases. One individual with ...