Phase I Study to Find the Best Dose of 177Lu-PSMA-617 for Advanced Prostate Cancer
Sponsor: Weill Medical College of Cornell University
ClinicalTrials ID:NCT03042468
This study aims to find the highest safe dose of the drug 177Lu-PSMA-617 for treating advanced prostate cancer that has spread and is not responding to standard treatments.
Patient Parameters
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Program Overview
The purpose of this study is to determine the highest dose of the drug 177Lu-PSMA-617 that can be given safely to patients with advanced prostate cancer that has spread and is not responding to other treatments. The study will test different dose levels to find the best one that does not cause severe side effects.
Description
This study is testing different doses of a drug called 177Lu-PSMA-617 to find the safest and most effective dose for treating advanced prostate cancer that has spread and is not responding to other treatments. The study will involve up to six different dose levels, with a few patients at each level to see how they respond. If a dose is found to be safe, more patients will receive that dose to further assess its safety and effectiveness.
Participants will receive two doses of 177Lu-PSMA-617, given two weeks apart. They will also undergo special imaging tests to track the cancer's response to the treatment. The study will last about 12 weeks, with eight visits to the clinic. Patients will be monitored for side effects and the study will continue to follow their health until the end of the study period.
The study includes routine tests and procedures, but also some special tests like PET/CT scans and blood samples for research purposes. Patients will be followed for survival and any side effects will be monitored until they resolve or stabilize.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of prostate cancer that has spread and is not responding to treatment.
- Evidence of cancer progression based on specific criteria, such as rising PSA levels or new bone lesions.
- Good overall health with a performance status score of 0 to 2.
- Low testosterone levels and ongoing hormone therapy if not surgically castrated.
- Previous treatment with certain cancer drugs or ineligibility/refusal of chemotherapy.
- Age 18 or older.
- Normal organ and bone marrow function, as shown by specific blood test results.
- Ability to understand and sign a consent form.
Exclusion Criteria
- Recent use of experimental drugs or devices.
- Previous treatment with certain radioactive drugs.
- Cancer spread to the brain or spinal fluid.
- Recent history of blood clots in veins or lungs.
- Serious illnesses affecting major organs that could interfere with the study.
- Recent radiation therapy for prostate cancer.
- Use of certain bone-strengthening drugs unless started at least four weeks before the study.
- Not willing to use effective birth control during the study and for one month after.
- Active cancer other than non-melanoma skin cancer, unless considered low risk of relapse.
- History of a specific blood disorder.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Tulane Cancer Center Clinic | 70112 | New Orleans | Louisiana |
| Weill Cornell Medical College | 10021 | New York | New York |
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