Study on Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel for Prostate Cancer Post-Surgery
Sponsor: NRG Oncology
ClinicalTrials ID:NCT03070886
This clinical trial is exploring whether adding the chemotherapy drug docetaxel to standard antiandrogen therapy and radiation therapy can improve treatment outcomes for patients with prostate cancer that has been surgically removed.
Patient Parameters
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Program Overview
The purpose of this study is to determine if adding the chemotherapy drug docetaxel to antiandrogen therapy and radiation therapy can better control prostate cancer that has been removed by surgery. Antiandrogen therapy reduces the amount of male hormones that can promote cancer growth, while radiation therapy uses high-energy rays to kill cancer cells. Docetaxel is a chemotherapy drug that can help stop cancer cells from growing and spreading. This study aims to see if this combination can help prevent the cancer from coming back or spreading.
Description
The study is divided into two phases. In Phase II, researchers will evaluate if adding docetaxel improves the time patients remain free from cancer progression. In Phase III, the focus will be on whether this combination improves survival without the cancer spreading.
Secondary goals include assessing overall survival, the time until cancer returns locally, and the levels of prostate-specific antigen (PSA) in the blood. The study will also explore the role of genetic profiling in deciding additional treatments after surgery and evaluate the side effects of docetaxel when combined with other therapies.
Participants will be randomly assigned to one of two groups:
- Group 1: Receives antiandrogen therapy for 6 months and radiation therapy for 7.5 weeks.
- Group 2: Receives the same antiandrogen and radiation therapy as Group 1, followed by docetaxel chemotherapy every 21 days for 6 cycles.
After completing the treatment, patients will have follow-up visits every 3 months for 2 years, then every 6 months for 3 years, and then annually.
Eligibility Criteria
Inclusion Criteria
- Had prostate cancer surgery with a Gleason score of 7 or higher.
- PSA level of 0.2 ng/ml or higher before starting hormone therapy.
- Testosterone level checked after surgery and before starting hormone therapy.
- Confirmed diagnosis of prostate adenocarcinoma at the time of surgery.
- Surgery performed within the last year.
- Available tumor sample for genetic analysis.
- Previous hormone therapy allowed if started within 30 days of study enrollment and lasted no more than 90 days before surgery.
- No cancer spread to lymph nodes or unknown lymph node status.
- Recent medical exams and scans showing no distant cancer spread.
- Good overall health with specific blood counts and organ function within normal limits.
- Willing to provide informed consent.
Exclusion Criteria
- Evidence of cancer spread beyond the prostate.
- History of other invasive cancers unless disease-free for at least 2 years.
- Previous radiation therapy that overlaps with study treatment areas.
- Previous chemotherapy for prostate cancer.
- Previous whole gland treatments like cryoablation for prostate cancer.
- Surgery performed more than a year ago.
- Severe health conditions like inflammatory bowel disease, active hepatitis, recent heart issues, or severe infections.
- HIV positive with low CD4 count unless well-managed with treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mobile Infirmary Medical Center | 36607 | Mobile | Alabama |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
| University of Arizona Cancer Center-Orange Grove Campus | 85704 | Tucson | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | 72401 | Jonesboro | Arkansas |
| Kaiser Permanente-Deer Valley Medical Center | 94531 | Antioch | California |
| Adventist Health Cancer Care Center Chico | 95973 | Chico | California |
| Kaiser Permanente Dublin | 94568 | Dublin | California |
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