Study on Fractionated and Multiple Dose 225Ac-J591 for Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Sponsor: Weill Medical College of Cornell University
ClinicalTrials ID:NCT04506567
This clinical trial is testing a new drug, 225Ac-J591, to find the best dose that can be given safely to men with advanced prostate cancer that has spread and is resistant to standard hormone therapy. The study also aims to see how well the drug works in reducing prostate-specific antigen (PSA) levels in patients.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study is designed to find the safest and most effective dose of a new drug, 225Ac-J591, for men with advanced prostate cancer that has spread and is resistant to hormone therapy. The trial will test two different dosing schedules to see which works best in lowering PSA levels, a marker of prostate cancer activity.
Description
This study is for men with advanced prostate cancer that has spread and is no longer responding to hormone therapy. The goal is to find the highest dose of the new drug, 225Ac-J591, that can be given without causing severe side effects. The study will test two different dosing schedules: one where the drug is given in two doses over two weeks, and another where it is given once every six weeks for up to four cycles. Participants will have regular check-ups, including scans and blood tests, to monitor their response to the treatment. After completing the treatment, participants will have follow-up visits to check on their health and any changes in their cancer.
Eligibility Criteria
Inclusion Criteria
- Men with confirmed prostate cancer that has spread and is resistant to hormone therapy.
- Evidence of cancer progression, such as rising PSA levels or new bone lesions.
- Low testosterone levels, maintained by ongoing hormone therapy if the patient has not had surgery to remove the testicles.
- Previous treatment with certain cancer drugs or chemotherapy.
- Age 18 or older.
- Normal organ and bone marrow function, as shown by specific blood tests.
- Good overall health, with a performance status score of 0 to 2.
- Ability to understand and agree to the study requirements.
- For certain participants, previous treatment with specific radioactive drugs.
Exclusion Criteria
- Recent use of experimental medical devices or drugs.
- Previous treatment with certain radioactive drugs.
- Untreated kidney issues or active brain cancer.
- Recent history of blood clots or serious illnesses affecting major organs.
- Recent radiation or chemotherapy for prostate cancer.
- Use of certain bone-strengthening medications unless started before the study.
- Not willing to use birth control if partners are of childbearing potential.
- Active cancer other than non-melanoma skin cancer.
- History of certain blood disorders.
- Specific findings on a bone scan that indicate widespread cancer.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Brooklyn Methodist Hospital - New York Presbyterian | 11215 | Brooklyn | New York |
| Weill Cornell Medicine | 10065 | New York | New York |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.