Shorter androgen deprivation in combination with radiation for high-risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial compares definitive external beam radiotherapy combined with either 6 months or 18 months of androgen deprivation therapy in high-risk localized prostate cancer. Patients will be treated with standard radiation therapy and assigned to a 6-month or an 18-month course of hormone therapy, with follow-up visits every 3 months for at least 5 years to monitor outcomes and safety. The study aims to see if shorter hormone therapy can provide similar cancer control while reducing treatment-related toxicity and impact on quality of life. It builds on prior evidence that longer hormone therapy improves outcomes but increases toxicity, and it accounts for advances in imaging and radiotherapy that may influence optimal treatment duration.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California San Diego
  La Jolla, California, United States Recruiting

Study contacts

• Principal investigator: Tyler Seibert, MD, PhD — University of California, San Diego
• Study coordinator: Tyler Seibert, MD, PhD
• Email: cancerCTO@health.ucsd.edu
• Phone: (858) 822-5354

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer

  This phase II trial tests leuprolide acetate alone versus with 177Lu-PSMA-617 (with or without abiraterone acetate and prednisone) in men with hormone-sensitive, low-volume metastatic prostate cancer.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07650240

• Lower-dose radiation to parts of the prostate for some men with prostate cancer

  This study tests whether a smaller amount of radiation aimed at specific parts of the prostate can reduce side effects compared with giving the full prostate the same dose.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07635238

• Next-generation SABR for prostate cancer across Ireland

  This test uses focused high-dose stereotactic radiotherapy (SABR) with urethra-sparing, a rectal spacer, and nerve preservation for men with low-, intermediate-, or selected high-risk prostate cancer to try to control the tumor while reducing side effects.

  Recruiting at 2 sites Phase 2 Cancer Trials Ireland · Dublin, Leinster and 3 other locations · NCT07552168

• Focal HDR-Brachytherapy for Prostate Cancer

  This trial tests using targeted high-dose-rate brachytherapy to treat prostate cancer patients and see if it provides local control with fewer side effects.

  Recruiting Jonsson Comprehensive Cancer Center · Los Angeles, California · NCT07468903

• PSMA PET/CT plus MRI to find higher‑grade prostate cancer in men on active surveillance

  This study tries adding rhPSMA-7.3 (flotufolastat F18) PET/CT to standard mpMRI to see if it finds higher-grade prostate cancer in men on active surveillance.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07285057

• Relugolix to improve PSMA PET/CT imaging in men with high or very high risk prostate cancer

  We are testing whether a short course of relugolix can boost PSMA levels and make PSMA PET/CT scans better at finding cancer in men with high or very high risk prostate cancer.

  Recruiting Phase 2 Mayo Clinic · Scottsdale, Arizona · NCT07025369

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.