Study on Enhanced 177Lu-PSMA-617 Treatment for Prostate Cancer with Low PSMA Expression
Sponsor: University of Washington
ClinicalTrials ID:NCT06526299
This clinical trial is exploring how well a treatment called 177Lu-PSMA-617 works for patients with prostate cancer that has spread and is resistant to standard treatments. The study aims to see if this treatment can improve outcomes for patients with low PSMA-expressing metastatic castrate-resistant prostate cancer.
Patient Parameters
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Program Overview
This phase II study is testing a treatment called 177Lu-PSMA-617 for prostate cancer that has spread to other parts of the body and is resistant to standard treatments. The treatment uses a radioactive component, Lutetium Lu 177, which targets prostate cancer cells and damages their DNA. This approach may help improve treatment results for patients with this type of cancer.
Description
In this study, patients will receive the treatment 177Lu-PSMA-617 through an IV over 30 minutes on specific days across several cycles. The treatment schedule includes doses on days 1, 8, 50, 57, 99, and 141, with cycles repeating every 7 days for the first and third cycles, and every 6 weeks for the second and subsequent cycles, up to a total of 6 cycles. Patients will also undergo various imaging tests, such as PSMA PET/CT and SPECT/CT, as well as CT or MRI scans, bone scans, and blood tests throughout the study. After completing the treatment, patients will have follow-up visits at 30 days and then every 12 weeks for up to 2 years.
Eligibility Criteria
Inclusion Criteria
- Must be able to understand and sign a consent form.
- Must be able to follow all study requirements.
- Must be 18 years or older.
- Must have a performance status score of 0 to 2, indicating good overall health.
- Must have a life expectancy of more than 6 months.
- Must have confirmed prostate cancer.
- Must have a positive PSMA PET/CT scan with no negative lesions.
- Must have a whole body tumor SUVmean of less than 10 on PSMA PET/CT scan.
- Must have had an orchiectomy or ongoing hormone therapy with low testosterone levels.
- Must have tried at least one androgen receptor pathway inhibitor.
- Must have been treated with 1 or 2 taxane regimens.
- Must have progressive metastatic castrate-resistant prostate cancer.
- Must have at least one metastatic lesion visible on recent imaging.
- Must have recovered from previous treatment side effects.
- Must meet specific blood count and organ function criteria.
- Must be on a stable bone-strengthening medication if applicable.
- HIV-positive patients must be healthy with a low risk of AIDS-related outcomes.
- Must use effective birth control if applicable.
- Must have controlled hepatitis B or cured hepatitis C if applicable.
Exclusion Criteria
- Previous treatment with certain radioactive therapies within 6 months.
- Any cancer treatment within 30 days before starting the study.
- Any investigational drugs within 30 days before starting the study.
- Known allergy to study treatment components.
- Concurrent cancer treatments or investigational therapies.
- Recent blood transfusion within 30 days before starting the study.
- History of brain metastases unless treated and stable.
- Serious medical conditions that could affect participation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California San Francisco | 94143 | San Francisco | California |
| Olive View-University of California Los Angeles Medical Center | 91342 | Sylmar | California |
| Fred Hutch/University of Washington Cancer Consortium | 98109 | Seattle | Washington |
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