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
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether hormone therapy (Androgen Deprivation Therapy) combined with radiation (External Beam Radiation Therapy) effectively treats prostate cancer. It compares two groups: one receives hormone therapy for 6 months, and the other for 18 months, both alongside radiation. The study aims to determine if the shorter treatment is equally effective in preventing the cancer from becoming resistant. Men with high-risk prostate cancer, who have not undergone surgery or other prostate cancer treatments, may be suitable candidates for this trial. Participants will attend checkups and monitor their medication doses for at least five years. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently on androgen deprivation therapy or other prostate cancer treatments, you may need to discuss this with the trial team, as prior systemic therapy for prostate cancer is an exclusion criterion.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining radiation therapy with short-term hormone treatment, known as androgen deprivation therapy (ADT), is generally safe but may cause some side effects. One study found that short-term ADT with radiation improved survival rates for prostate cancer patients. However, some patients experienced side effects like tiredness, hot flashes, and loss of muscle strength. These side effects are important to consider but can usually be managed.

For longer-term ADT, studies suggest it has similar safety, with common side effects including low energy, mood changes, and weight gain. These are typical of hormone treatments and usually aren't severe enough to stop treatment.

In summary, both short-term and long-term ADT with radiation have been studied and found to be generally safe, though they can cause some side effects. Discussing these potential effects with a doctor is important before joining a trial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore the combination of hormone therapy and radiation in new ways for prostate cancer. The first approach pairs radiotherapy with short-term androgen deprivation therapy (ADT) for six months, potentially enhanced by an androgen receptor pathway inhibitor. This may offer a quicker, more intense treatment option compared to standard long-term hormone therapy. The second approach involves radiotherapy with a longer, 18-month course of ADT, which could provide sustained tumor control. These strategies aim to optimize how hormone therapy is used alongside radiation, potentially improving outcomes and reducing side effects compared to current options.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research shows that combining radiation therapy with short-term hormone therapy (ST-ADT), which participants in this trial may receive, can improve outcomes for prostate cancer patients. One study found that 62% of patients who received this combined treatment were still alive after 10 years. Another study reported a 74.4% survival rate after 5 years, with 89.1% of patients surviving specifically from prostate cancer. In this trial, another group will receive longer hormone therapy, such as for 18 months, along with radiation. This longer treatment has been linked to a 63% reduction in the risk of death or cancer spreading. These findings suggest that both short-term and long-term hormone therapy with radiation are effective, but the longer treatment might offer extra protection against cancer progression.23678

Who Is on the Research Team?

TS

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.
See 7 more

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?

2

Treatment groups

Experimental Treatment

Active Control

Group I: RT + ST-ADTExperimental Treatment1 Intervention
Group II: RT + LT-ADTActive Control1 Intervention

Find a Clinic Near You

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+

Citations

The Benefit of Short-Term Androgen Deprivation Therapy ...

The present analysis confirms current knowledge that ST-ADT improves both OS and prostate-specific antigen-based outcomes for unselected ...

Radiotherapy and Short-Term Androgen Deprivation for ...

The 10-year rate of overall survival was 62% among patients receiving radiotherapy plus short-term ADT (the combined-therapy group), as compared ...

Outcomes following external beam radiotherapy to the ... - PMC

5-year overall survival and prostate cancer-specific survival were 74.4 and 89.1% respectively. 5-year failure-free survival was 55.4%; with 5-year biochemical ...

Interplay Between Duration of Androgen Deprivation ...

Prolonging ADT for 18 to 28 months was associated with a 63% reduction in death or metastasis with external beam radiotherapy; when a ...

The Benefit of Short-Term Androgen Deprivation Therapy ...

The present analysis confirms current knowledge that ST-ADT improves both OS and prostate-specific antigen-based outcomes for unselected patients with IR-PCa.

Impact of the duration of hormonal therapy following ... - PMC

Thus, the present study determined that ADT for ≥36 months combined with EBRT significantly improved the progression-free survival of patients with high-risk ...

Addition of short-term androgen deprivation therapy to ...

Although the addition of short-term ADT may improve prostate cancer outcomes, it can cause also significant side-effects including fatigue, hot flashes, loss of ...

Endocrine Therapy and Targeted Radiotherapy in Prostate ...

The goal of this clinical trial is to study definitive external beam radiation therapy together with drugs called androgen deprivation ...