Study on Radiation Therapy With or Without Apalutamide for Treating Recurrent Prostate Cancer (BALANCE Trial)
Sponsor: NRG Oncology
ClinicalTrials ID:NCT03371719
This clinical trial is exploring whether adding the drug apalutamide to radiation therapy can improve treatment outcomes for patients with prostate cancer that has returned after surgery. The study aims to see if this combination can better control the cancer compared to radiation therapy alone.
Patient Parameters
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Program Overview
This study is investigating if combining radiation therapy with the drug apalutamide can more effectively treat prostate cancer that has come back after surgery. Radiation therapy uses high-energy x-rays to kill cancer cells, while apalutamide is a medication that reduces the levels of androgens, hormones that can promote the growth of prostate cancer cells. The trial will compare the effectiveness of radiation therapy alone versus radiation therapy combined with apalutamide in controlling the cancer.
Description
The main goal of this study is to find out if adding apalutamide to radiation therapy can improve the time patients remain free from cancer progression after surgery for prostate cancer. The study will also look at other outcomes, such as overall survival, cancer-specific survival, and the spread of cancer to other parts of the body.
Participants will be randomly assigned to one of two groups:
- Group 1: Will receive radiation therapy alone for 7-8 weeks, along with a placebo (a pill with no active drug) taken daily for up to 6 cycles.
- Group 2: Will receive radiation therapy for 7-8 weeks, along with apalutamide taken daily for up to 6 cycles.
After completing the treatment, participants will have regular follow-up visits to monitor their health and the status of their cancer every 3 months for the first 2 years, then every 6 months for the next 3 years, and annually thereafter.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with prostate cancer and had surgery within the last 10 years.
- Detectable PSA levels between 0.1 and 1.0 ng/mL after surgery.
- Gleason score of 7-10 or specific disease characteristics.
- No evidence of cancer spread to lymph nodes or other parts of the body.
- Good overall health with a performance status score of 70-100.
- Available tumor tissue sample for genomic analysis.
- Prior hormone therapy is allowed if stopped at least 90 days before joining the study.
- Adequate blood counts and organ function based on specific tests.
- Willing to use effective birth control methods during and after the study.
- Agree not to donate sperm during and after the study.
- Provide informed consent to participate in the study.
Exclusion Criteria
- Evidence of cancer spread to other parts of the body or lymph nodes.
- History of other invasive cancers unless disease-free for at least 2 years.
- Previous chemotherapy for prostate cancer.
- Previous radiation therapy that overlaps with the study treatment area.
- History of seizures or conditions that increase seizure risk.
- Recent heart attack or severe heart conditions.
- Active infections or uncontrolled medical conditions.
- Prior whole gland ablative therapy for prostate cancer.
- HIV positive with low CD4 count or on certain HIV treatments.
- Participation in other clinical trials during the study.
- Unable to provide a tumor sample for genomic analysis if not previously done.
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 - Scottsdale | 85258 | Scottsdale | Arizona |
| Arizona Center for Cancer Care-Surprise | 85374 | Surprise | Arizona |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Alta Bates Summit Medical Center-Herrick Campus | 94704 | Berkeley | California |
| Marin General Hospital | 94904 | Greenbrae | California |
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
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