Study on Different Dosing Schedules of Lutetium 177Lu PSMA RLT for Advanced Prostate Cancer
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT07200830
This clinical trial is exploring whether changing the timing of doses for the prostate cancer drug Lutetium 177Lu PSMA RLT can improve quality of life without affecting lifespan in patients with advanced prostate cancer that is resistant to hormone therapy.
Patient Parameters
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Program Overview
This study is testing if adjusting the schedule of the prostate cancer treatment Lutetium 177Lu PSMA RLT can help improve the quality of life for patients with advanced prostate cancer that doesn't respond to hormone therapy. The drug targets a protein called PSMA found on cancer cells, delivering radiation to kill them. Typically, the drug is given every 6 weeks for up to 6 doses. This trial will see if delaying further doses after the first two, until signs of cancer activity appear, can be just as effective while improving patients' quality of life.
Description
The study has several goals:
Primary Goals:
- Compare the overall survival of patients receiving adaptive dosing of Lutetium 177Lu PSMA RLT based on PSA levels to those receiving the standard dosing every 6 weeks.
- Compare the quality of life of patients using a specific questionnaire over the first 30 months.
Secondary Goals:
- Compare how long patients stay on treatment between the two dosing schedules.
- Compare how long patients live without the cancer getting worse between the two groups.
- Evaluate and compare side effects between the two dosing methods.
- Compare changes in PSA levels between the two dosing methods.
- Compare quality-adjusted life years, which considers both survival and health quality, between the two groups.
- Compare pain levels between the two groups at 12 and 30 months.
Exploratory Goals:
- Investigate genetic changes in tumors in patients with different PSA responses after two cycles of treatment.
- Explore the relationship between overall survival and initial PSA response before randomization.
Study Process:
- Initial Step: Patients receive Lutetium 177Lu PSMA RLT every 6 weeks for up to 2 cycles. If PSA levels drop by 50% or more, they move to the next step.
- Randomization Step: Patients are divided into two groups. One group continues with the standard dosing every 6 weeks. The other group has their PSA levels monitored every 3 weeks, and further doses are given only if PSA levels rise or if there are signs of cancer progression.
Throughout the study, patients will have regular blood tests, CT scans, bone scans, and possibly MRI scans if needed. After treatment, patients will be monitored every 12 weeks until the cancer progresses, and then every 6 months for up to 5 years.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of prostate adenocarcinoma.
- Positive PSMA PET/CT scan showing cancer spread.
- PSA level greater than 2.0 ng/mL.
- Progressive metastatic castration-resistant prostate cancer (mCRPC) based on specific criteria.
- Previous orchiectomy or ongoing hormone therapy with low testosterone levels.
- Prior treatment with at least one androgen receptor pathway inhibitor.
- No previous taxane-based chemotherapy for mCRPC.
- Recovery from previous treatment side effects to a mild level.
- Stable use of bone-strengthening medications for at least 30 days.
- No recent treatment with certain radioactive therapies or systemic anti-cancer therapies.
- Age 18 or older.
- Good overall health with a performance status of 2 or less.
- Adequate blood cell counts and organ function.
- No acute biliary or urinary obstruction.
- Treated and stable brain metastases, if present.
- Controlled HIV, hepatitis B, or hepatitis C infections, if applicable.
- No recent use of investigational agents or other cancer therapies.
- No known allergies to study medications.
- Ability to understand and consent to the study in English or Spanish.
- Completion of 2 doses of Lutetium 177Lu PSMA RLT with a significant PSA decline.
- Continued good health and organ function at registration.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| AIS Cancer Center at San Joaquin Community Hospital | 93301 | Bakersfield | California |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | 92612 | Irvine | California |
| City of Hope at Irvine Lennar | 92618 | Irvine | California |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| Helen F Graham Cancer Center | 19713 | Newark | Delaware |
| Medical Oncology Hematology Consultants PA | 19713 | Newark | Delaware |
| CTCA at Southeastern Regional Medical Center | 30265 | Newnan | Georgia |
| Kootenai Health - Coeur d'Alene | 83814 | Coeur d'Alene | Idaho |
| Kootenai Clinic Cancer Services - Post Falls | 83854 | Post Falls | Idaho |
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