Prostate AdenocarcinomaPhase 2SENTRYNCT07364071
Strategic Endocrine Therapy and Targeted Radiotherapy for Prostate Cancer
A Phase 2 study testing Radiation therapy in people with Prostate Adenocarcinoma, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2026to Apr 2034
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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).
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- Chemotherapy for prostate cancer.
- Prior pelvic radiotherapy.
- Any condition that, in the investigator's judgment, would compromise the patient's safety or compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego
La Jolla, California, 92093
Tyler Seibert, MD, PhD, 858-822-5354, cancerCTO@health.ucsd.edu
Genitourinary Research Team, 858-822-5354, cancerCTO@health.ucsd.edu
About this study
Official title: Strategic ENdocrine and Targeted Radiation therapY
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?
Read more
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.
Read the detailed 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 treatment time. A trial studying shorter duration of hormone therapy is warranted for the following reasons.
First, the trials that established the benefits of long-term hormone therapy were conducted over 20 years ago. Since then, advances in staging imaging and image-guided biopsy techniques have led to major stage migration in prostate cancer that has improved the prognosis of patients with disease categorized as high risk but localized. Second, substantial improvements in radiotherapy techniques have made it possible to deliver higher, more ablative radiation doses to the tumor while sparing normal organs. Third, even recurrent disease after definitive radiotherapy can now be detected early and managed with advanced radiotherapy (stereotactic ablative radiotherapy) to delay a need for salvage hormone therapy. Fourth, recent randomized trials have demonstrated that combining conventional androgen-deprivation therapy - usually accomplished with a gonadotropin-releasing hormone agonist or antagonist - with an androgen receptor pathway inhibitor is safe and improves overall survival in advanced prostate cancer.
These advances suggest that modern radiotherapy combined with short-term androgen deprivation therapy - and an optional androgen receptor pathway inhibitor - may achieve outcomes comparable to radiotherapy with long-term androgen deprivation therapy. This strategy offers the potential to maintain tumor control, reduce treatment-related morbidity, and improve patient survivorship. This randomized trial will compare the efficacy and toxicity of this novel treatment approach against the current standard of care. The investigators hypothesize that the novel treatment approach will have excellent disease control - comparable to that achieved with traditional long term androgen deprivation therapy - while improving quality of life.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Radiation therapy
- Keywords
- Radiotherapy, Androgen deprivation therapy, Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
Radiotherapy with short-term androgen deprivation therapy plus, if indicated, an androgen receptor pathway inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| RT + ST-ADT | Experimental | Radiotherapy with short-term androgen deprivation therapy (6 months) plus, if indicated, an androgen receptor pathway inhibitor. Receives: Radiation: Radiation therapy |
| RT + LT-ADT | Active comparator | Radiotherapy with long-term androgen deprivation therapy (18 months). Receives: Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure-free survival
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:
- Death from any cause.
- Initiation of salvage hormone therapy as defined in the protocol.
- 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).
Measured: Within 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start20 Jul 2026
- Primary completionApr 2031 (estimated)
- Study completionApr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Lantheus
- Responsible party
- Principal investigator, Tyler Seibert, University of California, San Diego
- Investigators
- Tyler Seibert, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364071
- Sponsor's protocol ID
- 813314
- Acronym
- SENTRY
- Status last verified
- Jul 2026
- First submitted
- 15 Jan 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic ENdocrine and Targeted Radiation therapY
- ClinicalTrials.gov ID
- NCT07364071
- Acronym / sponsor ID
- SENTRY / 813314
- Conditions
- Prostate Adenocarcinoma
- Keywords
- Radiotherapy, Androgen deprivation therapy, Prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Lantheus
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2034 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 treatment time. A trial studying shorter duration of hormone therapy is warranted for the following reasons.
First, the trials that established the benefits of long-term hormone therapy were conducted over 20 years ago. Since then, advances in staging imaging and image-guided biopsy techniques have led to major stage migration in prostate cancer that has improved the prognosis of patients with disease categorized as high risk but localized. Second, substantial improvements in radiotherapy techniques have made it possible to deliver higher, more ablative radiation doses to the tumor while sparing normal organs. Third, even recurrent disease after definitive radiotherapy can now be detected early and managed with advanced radiotherapy (stereotactic ablative radiotherapy) to delay a need for salvage hormone therapy. Fourth, recent randomized trials have demonstrated that combining conventional androgen-deprivation therapy - usually accomplished with a gonadotropin-releasing hormone agonist or antagonist - with an androgen receptor pathway inhibitor is safe and improves overall survival in advanced prostate cancer.
These advances suggest that modern radiotherapy combined with short-term androgen deprivation therapy - and an optional androgen receptor pathway inhibitor - may achieve outcomes comparable to radiotherapy with long-term androgen deprivation therapy. This strategy offers the potential to maintain tumor control, reduce treatment-related morbidity, and improve patient survivorship. This randomized trial will compare the efficacy and toxicity of this novel treatment approach against the current standard of care. The investigators hypothesize that the novel treatment approach will have excellent disease control - comparable to that achieved with traditional long term androgen deprivation therapy - while improving quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT + ST-ADT | Experimental | Radiation: Radiation therapyRadiotherapy with short-term androgen deprivation therapy (6 months) plus, if indicated, an androgen receptor pathway inhibitor. |
| RT + LT-ADT | Active comparator | Radiation: Radiation therapyRadiotherapy with long-term androgen deprivation therapy (18 months). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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):
- No evidence of distant metastasis, confirmed by:
- 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.
Key exclusion criteria (9 listed)
- 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:
- Prior pelvic radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapyRadiotherapy with short-term androgen deprivation therapy plus, if indicated, an androgen receptor pathway inhibitor. | Radiation | RT + LT-ADT, RT + ST-ADT |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tyler Seibert, MD, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation therapy in people with Prostate Adenocarcinoma, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tyler Seibert, MD, PhD ((858) 822-5354, cancerCTO@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure-free survival (time frame: Within 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.