Study Comparing 177Lu-PSMA-617 and Hormone Therapy for Advanced Prostate Cancer
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT04689828
This clinical trial is testing whether a new treatment, 177Lu-PSMA-617, can improve survival and slow disease progression in men with advanced prostate cancer compared to changing their current hormone therapy.
Patient Parameters
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Program Overview
The study aims to find out if 177Lu-PSMA-617 can help men with advanced prostate cancer live longer or slow down the progression of their disease compared to changing their current hormone therapy. It involves 469 participants who have not been treated with certain chemotherapy drugs before. Participants are randomly assigned to receive either 177Lu-PSMA-617 or a different hormone therapy. The study will last about 43 months, and participants will undergo various tests and treatments during this time.
Description
This study is designed to compare the effectiveness of a new treatment, 177Lu-PSMA-617, with a change in hormone therapy for men with advanced prostate cancer that has spread and is resistant to standard hormone treatments. Participants will be randomly assigned to one of two groups: one group will receive 177Lu-PSMA-617, and the other will receive a different hormone therapy. The study will monitor how long participants live and how long it takes for their cancer to progress.
Participants will undergo a screening process to ensure they meet the study criteria, including a special scan to confirm their cancer is suitable for the study. Those who qualify will be randomly assigned to receive either 177Lu-PSMA-617 or a different hormone therapy. The treatment will continue until the cancer progresses or the participant completes the treatment cycles.
After treatment, participants will have follow-up visits to monitor their health and any side effects. If the cancer progresses, participants in the hormone therapy group may switch to receive 177Lu-PSMA-617 if they meet certain criteria. The study will also collect long-term safety and effectiveness data to understand the impact of the treatments better.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have advanced prostate cancer confirmed by medical tests.
- Must have a specific scan showing the cancer is suitable for the study.
- Must have low testosterone levels due to previous treatments.
- Must have tried and progressed on one type of advanced hormone therapy.
- Must have at least one cancer lesion visible on scans.
- Must have good organ function and be in relatively good health.
- Must not have had certain treatments or conditions that could interfere with the study.
Exclusion Criteria
- Previous treatment with certain radioactive drugs or chemotherapy for prostate cancer.
- Known allergies to study drugs or similar medications.
- Active brain metastases or other serious medical conditions.
- Significant heart problems or other health issues that could affect participation.
- Other active cancers that could interfere with the study.
- Inability to comply with study requirements or understand the study procedures.
- Men must agree to use contraception during the study and for a period after to prevent pregnancy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Rocky Mountain Cancer Centers | 80218 | Denver | Colorado |
| University of Florida | 32610 | Gainesville | Florida |
| Tulane Uni Health Sciences Center | 70112 | New Orleans | Louisiana |
| Dana Farber Cancer Institute | 02115 | Boston | Massachusetts |
| Beth Israel Deaconess Med Ctr | 02215 | Boston | Massachusetts |
| WA Uni School Of Med | 63110 | St Louis | Missouri |
| Urology Cancer Center PC | 68130 | Omaha | Nebraska |
| Nebraska Cancer Specialists | 68154 | Omaha | Nebraska |
| NYU Laura and Isaac Perlmutter Cancer Center | 10016 | New York | New York |
| Memorial Sloan Kettering Cancer Ctr | 10017 | New York | New York |
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