Study on 177Lu-J591 and Ketoconazole for Prostate Cancer Treatment
Sponsor: Weill Medical College of Cornell University
ClinicalTrials ID:NCT00859781
This clinical trial is testing a new treatment combining the experimental drug 177Lu-J591 with ketoconazole and hydrocortisone to see if it can effectively target and treat prostate cancer that has returned after initial treatments.
Patient Parameters
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Program Overview
The study aims to evaluate the effectiveness of a new treatment for prostate cancer that has come back after surgery or radiation and has not been cured by standard hormonal therapy. The treatment involves an experimental drug, 177Lu-J591, which is designed to find and destroy prostate cancer cells by delivering radiation directly to them, while minimizing exposure to normal tissues. The study will also use ketoconazole, a drug that can temporarily lower PSA levels, and hydrocortisone.
Description
This research is being conducted because current treatments for prostate cancer that has returned after surgery or radiation are not curative. The experimental drug, 177Lu-J591, is designed to target prostate cancer cells specifically and deliver a lethal dose of radiation to them, sparing normal tissues as much as possible. The drug includes an antibody called J591, which binds to prostate cancer cells, and a radioactive metal, 177Lutetium, which provides the radiation. The study will also use 111Indium, a radioactive particle that helps researchers take images but does not kill cancer cells. This study will assess whether the energy from the radioactive compound can effectively kill cancer cells.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of prostate cancer that has been treated with surgery and/or radiation.
- Rising PSA levels after medical or surgical castration.
- High risk of cancer spreading, defined by rising PSA and either a PSA level over 20 ng/mL or a PSA doubling time of less than 8 months.
- No evidence of cancer returning locally or spreading to distant sites.
- Age over 18 years.
- Low testosterone levels (below 50 ng/ml).
- Men capable of fathering children must agree to use effective contraception during the trial.
- Stable dose of bisphosphonate therapy if applicable, started more than 4 weeks before the trial.
- Ability to understand and sign a written informed consent document.
Exclusion Criteria
- Recent use of blood transfusions or growth factors within 4 weeks of treatment.
- Recent chemotherapy or radiation therapy within 4 weeks of treatment.
- Previous radiation therapy covering more than 25% of the skeleton.
- Previous treatment with certain radioactive compounds.
- Low platelet count or blood cell counts.
- Abnormal blood clotting or kidney function.
- Active serious infections or heart conditions.
- Poor overall health or life expectancy less than 12 months.
- Recent history of blood clots.
- Other serious illnesses that could interfere with the study.
- Recent use of investigational therapies or certain medications.
- Known history of HIV or other active cancers.
- Recent use of certain hormone inhibitors or medications for prostate cancer.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cedars Sinai | 90048 | Los Angeles | California |
| USC/Norris Comprehensive cancer center | 90089 | Los Angeles | California |
| Georgetown University Medical Center | 20007 | Washington D.C. | District of Columbia |
| Indiana University Melvin and Bren Simon Cancer Center | 46202 | Indianapolis | Indiana |
| University of Iowa Hospitals and Clinics | 52242 | Iowa City | Iowa |
| The University of Kansas Cancer Center | 66205 | Westwood | Kansas |
| Weill Cornell Medical College | 10021 | New York | New York |
| UPMC Hillman Cancer Center | 15232 | Pittsburgh | Pennsylvania |
| University of Utah | 84108 | Salt Lake City | Utah |
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