Strategic Endocrine Therapy and Targeted Radiotherapy for Prostate Cancer
Recruiting · NCT07364071 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Diego
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
Inclusion criteria
- Histologically confirmed adenocarcinoma of the prostate.
- High-risk localized prostate cancer, defined as ≥1 of the following (per National Comprehensive Cancer Network or D'Amico criteria):
- Prostate specific antigen ≥ 20 ng/mL
- Gleason score 8-10
- 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
- No evidence of distant metastasis, confirmed by:
- a. Prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) or equivalent staging imaging
- Planning to receive definitive external beam radiotherapy and hormone therapy as standard of care (on label or medically accepted) treatment
- Eastern Cooperative Oncology Group performance status 0-1.
- Age ≥ 18 years.
- Willingness to use adequate contraception if sexually active and of reproductive potential
- Ability to understand and willingness to sign informed consent.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
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.
Where it is running
1 location listed across 1 US state.
- University of California San Diego - La Jolla, California, United States