Study on Salvage Radiotherapy With or Without Enzalutamide for Recurrent Prostate Cancer After Surgery
Sponsor: RTOG Foundation, Inc.
ClinicalTrials ID:NCT03809000
This clinical trial is exploring whether adding the drug enzalutamide to standard hormone therapy and radiation can improve outcomes for men with prostate cancer that has returned after surgery.
Patient Parameters
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Program Overview
The study aims to find out if using enzalutamide, a medication that blocks male hormones, along with standard hormone therapy and radiation, can help men with prostate cancer that has come back after surgery. Researchers want to see if this combination can better prevent the cancer from progressing compared to using standard hormone therapy and radiation alone.
Description
The main goal of this study is to determine if adding enzalutamide to standard hormone therapy and radiation can improve the time men with recurrent prostate cancer remain free from disease progression. This study focuses on men whose prostate cancer has returned after surgery and shows aggressive features. Participants will receive either standard hormone therapy with radiation or enhanced hormone therapy with enzalutamide and radiation to compare the effectiveness of these treatments.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with prostate cancer confirmed by surgery within the last 10 years.
- PSA level of 0.2 ng/mL or higher within 120 days before joining the study.
- Started hormone therapy no more than 42 days before joining the study.
- Blood counts and organ function within specified limits.
- At least one aggressive cancer feature, such as a high Gleason score or cancer spread to nearby areas.
- Good overall health with a performance status of 0 or 1.
Exclusion Criteria
- Evidence of cancer spread beyond nearby lymph nodes.
- History of other invasive cancers unless disease-free for at least 2 years.
- Previous chemotherapy for prostate cancer.
- Previous radiation that overlaps with the study treatment area.
- Certain medical conditions, such as recent heart attack, severe heart disease, or uncontrolled high blood pressure.
- History of seizures or conditions that increase seizure risk.
- Active infections or gastrointestinal disorders affecting medication absorption.
- HIV positive with low CD4 count or on certain HIV treatments.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Arizona Center for Cancer Care - Gilbert | 85297 | Gilbert | Arizona |
| Arizona Center for Cancer Care - Peoria | 85381 | Peoria | Arizona |
| Arizona Center for Cancer Care - Phoenix | 85027 | Phoenix | Arizona |
| Arizona Center for Cancer Care - Scottsdale East | 85251 | Scottsdale | Arizona |
| Arizona Center for Cancer Care - Scottsdale North | 85258 | Scottsdale | Arizona |
| Arizona Center for Cancer Care - Surprise | 85374 | Surprise | Arizona |
| Marin Cancer Care, Inc. | 94904 | Greenbrae | California |
| Marin Health Medical Center | 94904 | Greenbrae | California |
| University of Southern California | 90033 | Los Angeles | California |
| USC Medical Center - Los Angeles County | 90033 | Los Angeles | California |
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