Hormone + Radiation Therapy for Prostate Cancer

(SENTRY Trial)

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of California, San Diego

Must be taking: Androgen deprivation therapy

Must not be taking: Androgen receptor inhibitors, Chemotherapy

Disqualifiers: Metastatic disease, Prior prostatectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 6-18 months

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Tyler Seibert, MD, PhD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

Men over 18 with advanced prostate cancer (Gleason score 8-10, PSA ≥20 ng/mL, stage T3a or higher) who plan to receive standard radiotherapy and hormone therapy. They must understand the study and agree to sign consent, be willing to use contraception if needed, and have a performance status showing they can handle daily activities.

Inclusion Criteria

I can understand and am willing to sign the informed consent.

My prostate cancer is confirmed by tissue analysis.

My PSA level is 20 ng/mL or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive definitive external beam radiation therapy and androgen deprivation therapy for either 6 or 18 months

6-18 months

Visits every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Visits every 3 months, with in-person visits at 3 months, 1 year, and 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Androgen Deprivation Therapy
• External Beam Radiation Therapy

Trial Overview

The trial is testing whether giving men with prostate cancer hormone-blocking drugs for just 6 months is as effective as the usual 18 months when combined with radiation therapy. The focus is on long-term outcomes like needing more treatment or developing resistance within five years.

How Is the Trial Designed?

Group I: RT + ST-ADT Experimental Treatment 1 Intervention

Radiotherapy with short-term androgen deprivation therapy (6 months) plus, if indicated, an androgen receptor pathway inhibitor.

Group II: RT + LT-ADT Active Control 1 Intervention

Radiotherapy with long-term androgen deprivation therapy (18 months).

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Lantheus

Collaborator

Trials

1

Recruited

180+