Strategic Endocrine Therapy and Targeted Radiotherapy for Prostate Cancer (NCT07364071)
Strategic ENdocrine and Targeted Radiation therapY
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to study definitive external beam radiation therapy together with drugs called androgen deprivation therapy (ADT) in patients with prostate cancer. The investigators want to find out if these drugs work the same way if they are given for 6 months or for the usual 18 months in patients who receive also definitive external beam radiotherapy. The investigators will also learn about the safety of the treatments. The main questions the study aims to answer are: Do patients who get radiation therapy plus 6 months of androgen deprivation therapy need other hormone therapy or develop castration resistance at a higher rate within 5 years, compared to patients who get radiation therapy plus 18 months of androgen deprivation therapy? Participants will: Be treated with definitive external beam radiation therapy and receive androgen deprivation therapy for 6 months or 18 months. Have visits once every 3 months for checkups and tests for at least 5 years. The visits at 3 months, 1 year, and 5 years need to be done in person; all the other visits can be done in person or remotely (telehealth). Keep a diary of the missed doses of the androgen deprivation therapy.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (10 items).
Location: University of California San Diego — La Jolla, California
Age range: 18 Years
🧪 Interventions in This Study
- Radiation therapy (RADIATION)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Evidence of metastatic disease, including nodal disease beyond the pelvis or distant metastases on imaging.
- Clear evidence of regional nodal disease on conventional imaging.
- Prior prostatectomy.
- Prior systemic therapy for prostate cancer, including:
- Androgen deprivation therapy (Note that participants who have started Androgen deprivation therapy within 90 days prior to randomization can be enrolled.)
- Androgen receptor pathway inhibitor (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).
- Chemotherapy for prostate cancer.
- Prior pelvic radiotherapy.
- Any condition that, in the investigator's judgment, would compromise the patient's safety or compliance.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of California San Diego — La Jolla, California
📞 Contact the Study Coordinator
Phone: (858) 822-5354
Email: cancerCTO@health.ucsd.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer — Birmingham, Alabama
- Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer — Houston, Texas
- Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study — Pittsburgh, Pennsylvania
- Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Screening Prostate Cancer — Houston, Texas
Explore by condition: All Prostate Adenocarcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.