Strategic Endocrine Therapy and Targeted Radiotherapy for Prostate Cancer

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07364071
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Prostate Adenocarcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation therapy — RADIATION
    Radiotherapy with short-term androgen deprivation therapy plus, if indicated, an androgen receptor pathway inhibitor.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Jan 2026
Primary completion
Apr 30, 2031
Completion
Apr 30, 2034

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RT + ST-ADT
    Radiotherapy with short-term androgen deprivation therapy (6 months) plus, if indicated, an androgen receptor pathway inhibitor.
  • Active Comparator: RT + LT-ADT
    Radiotherapy with long-term androgen deprivation therapy (18 months).

Primary Outcome Measure

Failure-free survival [ Time Frame: Within 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093
Tyler Seibert, MD, PhD
[email protected]
858-822-5354
Genitourinary Research Team
[email protected]
858-822-5354

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By research site
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