NCT07364071 · University of California, San Diego
Strategic Endocrine Therapy and Targeted Radiotherapy for Prostate Cancer
(SENTRY)
What this study 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.
View original scientific description
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.
Interventions
RADIATION
Radiation therapy
Radiotherapy with short-term androgen deprivation therapy plus, if indicated, an androgen receptor pathway inhibitor.
Primary outcome measures
Failure-free survival
Time frame: Within 5 years
To compare failure-free survival of radiotherapy plus short-term androgen deprivation therapy plus, if indicated, an androgen receptor pathway inhibitor to that of radiotherapy plus long-term androgen deprivation therapy. Participants will be considered to have failure-free survival if they do not experience any of the events in the 5 years after the end of radiation therapy: 1. Death from any cause. 2. Initiation of salvage hormone therapy as defined in the protocol. 3. Castration resistance per the Prostate Cancer Clinical Trials Working Group 3 definition. Castration resistance is defined as biochemical or clinical progression - as defined in the protocol - while serum testosterone is at castrate levels (\<50 ng/dL).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- La Jolla, California
Collaborators
Lantheus
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 4, 2026 · Source of record for eligibility and locations