Strategic ENdocrine and Targeted Radiation therapY
University of California, San Diego
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.
Description
Definitive radiation therapy combined with hormone therapy improves oncologic outcomes in patients with high-risk prostate cancer. However, hormone therapy has substantial toxicity, including metabolic and cardiovascular, and negatively impacts quality-of-life. Previous trials demonstrated that long-term hormone therapy lasting 18-36 months improved overall survival compared to short-term hormone therapy lasting only 4-6 months. However, long-term hormone therapy also extends the duration of treatment-related toxicity. There is great interest among patients and physicians to reduce the total t…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 tom…
Interventions
- RadiationRadiation therapy
Radiotherapy with short-term androgen deprivation therapy plus, if indicated, an androgen receptor pathway inhibitor.
Location
- University of California San DiegoLa Jolla, California