Study on 177Lu-PSMA-I&T for Advanced Prostate Cancer Resistant to Hormone Therapy
Sponsor: Curium US LLC
ClinicalTrials ID:NCT05204927
This clinical trial is comparing a new treatment, 177Lu-PSMA-I&T, with standard hormone therapy in men with advanced prostate cancer that no longer responds to hormone treatment. The study aims to evaluate the safety and effectiveness of this new approach.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is testing a new treatment called 177Lu-PSMA-I&T against standard hormone therapy in men with advanced prostate cancer that has spread and is resistant to hormone therapy. The trial will involve 400 participants who will be randomly assigned to receive either the new treatment or hormone therapy. The new treatment involves up to 6 doses given every 6 weeks. Researchers will monitor participants for side effects and track the progression of the cancer using scans and blood tests. A smaller group of 30 participants will undergo additional imaging to study how the treatment is distributed in the body.
Description
This clinical trial is designed to evaluate a new treatment, 177Lu-PSMA-I&T, for men with advanced prostate cancer that has spread and is resistant to hormone therapy. The study will include 400 participants who will be randomly assigned to receive either the new treatment or standard hormone therapy (abiraterone or enzalutamide). Participants receiving the new treatment will have up to 6 doses, each given every 6 weeks. Throughout the study, participants will be monitored for side effects and the progression of their cancer will be assessed using scans and blood tests. A subgroup of 30 participants will participate in a detailed study of how the treatment is distributed in the body using special imaging techniques. This subgroup will not be randomized and will receive additional imaging after each treatment cycle.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 or older who can understand and sign a consent form.
- Diagnosed with prostate cancer that has spread and is resistant to hormone therapy.
- Cancer must be progressing, shown by rising PSA levels or new bone lesions.
- Previously treated with one type of hormone therapy but cancer progressed.
- Positive PSMA-PET scan.
- Low testosterone levels maintained by ongoing treatment.
- Able to attend study visits and follow-up.
- HIV-positive patients can participate if healthy and low risk.
- Patients with managed HBV or HCV can participate.
- Life expectancy of at least 6 months.
- Willing to start hormone therapy if needed.
- Use effective birth control if partner is of childbearing potential.
Exclusion Criteria
- Previous treatment with similar radioligand therapies.
- Recent treatment with radium-223.
- Previous chemotherapy for hormone-resistant prostate cancer, except limited prior docetaxel use.
- Poor overall health with a performance status of 2 or higher.
- Known genetic mutations not treated with specific drugs.
- Current use of other cancer treatments or investigational drugs.
- Poor organ or bone marrow function based on specific blood test results.
- Recent major surgery or significant heart disease.
- Active infections or other cancers, except certain skin or bladder cancers.
- Recent use of certain bone-targeted therapies.
- Active COVID-19 infection; recovered patients may join after full recovery and a negative test.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Arizona Institute of Urology, PPLC | 85704 | Tucson | Arizona |
| Providence Medical Foundation | 92835 | Fullerton | California |
| Long Beach Memorial Center | 90806 | Long Beach | California |
| Hoag Memorial Hospital Presbyterian | 92663 | Newport Beach | California |
| San Francisco VA Health Care System | 94121 | San Francisco | California |
| University of California, San Francisco | 94158 | San Francisco | California |
| Providence Saint John's Health Center | 90404 | Santa Monica | California |
| GenesisCare USA | 33431 | Boca Raton | Florida |
| Biogenix Molecular LLC | 33165 | Miami | Florida |
| Orlando Health Cancer Institute | 32806 | Orlando | Florida |
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