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Radiation

Radiation and Hormone Therapy for Prostate Cancer (DIVINE Trial)

Phase 2

Recruiting

Led By Jacob J. Orme, M.D., Ph.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical confirmation of metachronous (metastatic) recurrent hormone-sensitive prostate cancer

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2

Must not have

Chemotherapy for prostate cancer at any time

Surgery ≤ 3 weeks prior to registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effects of a type of radiation therapy called stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) and

Who is the study for?

This trial is for men with hormone-sensitive prostate cancer that has spread and returned after improving. Participants should not have allergies to the treatments used in the study, which include various medications and radiation therapy.

What is being tested?

The DIVINE Trial is testing how well stereotactic body radiation therapy (SBRT) works alone or when combined with ARPIs and ADT in treating metastatic, recurrent prostate cancer. It compares different treatment timings to see which is more effective.

What are the potential side effects?

Possible side effects include fatigue, skin reactions from radiation, hormonal changes due to ADT leading to hot flashes or decreased libido, and potential risks associated with ARPIs like joint pain, high blood pressure, and liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has returned and spread, responding to hormone therapy.

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I am able to care for myself and perform daily activities.

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I am 18 years old or older.

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I have up to 5 cancer spread sites, with at least one outside my pelvis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received chemotherapy for prostate cancer.

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I had surgery less than 3 weeks ago.

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I have had treatment specifically for cancer that has spread.

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I have unstable chest pain.

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I currently have an infection.

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I have symptoms of heart failure.

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I have an irregular heartbeat.

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I have had a heart attack in the last 6 months or need ongoing treatment for severe heart rhythm problems.

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I need constant oxygen because of severe breathing problems from my advanced illness.

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I am not taking any experimental drugs for my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Modified radiographic progression-free survival (mrPFS)

Secondary study objectives

Adverse event (AE) rate

Biologic progression-free survival (bPFS)

Overall survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group B (SBRT, watchful waiting)Experimental Treatment8 Interventions

Patients undergo SBRT with watchful waiting. Cycles repeat every 4 months (16 weeks) in the absence of disease progression or unacceptable toxicity.

Group II: Group A (SBRT, APRI, ADT)Active Control19 Interventions

Patients undergo SBRT and receive APRI (abiraterone and prednisone, apalutamide, darolutamide, or enzalutamide) and ADT (leuprolide, triptorelin, histrelin, goserelin, degarelix, or relugolix). Cycles repeat every 4 months (16 weeks) for up to 6 months in the absence of unacceptable toxicity. Patients then undergo watchful waiting thereafter until disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Positron Emission Tomography

2011

Completed Phase 2

~2200