NCT07364071 Strategic Endocrine Therapy and Targeted Radiotherapy for Prostate Cancer
| NCT ID | NCT07364071 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, San Diego |
| Condition | Prostate Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-07-20 |
| Primary Completion | 2031-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2026-07-20 with a primary completion date of 2031-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate. 2. High-risk localized prostate cancer, defined as ≥1 of the following (per National Comprehensive Cancer Network or D'Amico criteria): 1. Prostate specific antigen ≥ 20 ng/mL 2. Gleason score 8-10 3. Clinical stage T3a or higher; imaging can be used to determine T stage if there is macroscopic (gross) extraprostatic extension or invasion of the seminal vesicles or other non-prostate organs 3. No evidence of distant metastasis, confirmed by: a. Prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) or equivalent staging imaging 4. Planning to receive definitive external beam radiotherapy and hormone therapy as standard of care (on label or medically accepted) treatment 5. Eastern Cooperative Oncology Group performance status 0-1. 6. Age ≥ 18 years. 7. Willingness to use adequate contraception if sexually active and of reproductive potential 8. Ability to understand and willingness to sign informed consent. 9. Stated willingness to comply with all study procedures and availability for the duration of the study. Exclusion Criteria: 1. Evidence of metastatic disease, including nodal disease beyond the pelvis or distant metastases on imaging. 2. Clear evidence of regional nodal disease on conventional imaging. 3. Prior prostatectomy. 4. Prior systemic therapy for prostate cancer, including: 1. Androgen deprivation therapy (Note that participants who have started Androgen deprivation therapy within 90 days prior to randomization can be enrolled.) 2. Androgen receptor pathway inhibitor (e.g., abiraterone, enzalutamide, apalutamide, darolutamide). 3. Chemotherapy for prostate cancer. 5. Prior pelvic radiotherapy. 6. Any condition that, in the investigator's judgment, would compromise the patient's safety or compliance.
Contact & Investigator
Tyler Seibert, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT07364071 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07364071 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07364071 currently recruiting?
Yes, NCT07364071 is actively recruiting participants. Contact the research team at cancerCTO@health.ucsd.edu for enrollment information.
Where is the NCT07364071 trial being conducted?
This trial is being conducted at La Jolla, United States.
Who is sponsoring the NCT07364071 clinical trial?
NCT07364071 is sponsored by University of California, San Diego. The principal investigator is Tyler Seibert, MD, PhD at University of California, San Diego. The trial plans to enroll 150 participants.