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Radiation

Group B (SBRT, watchful waiting) for Prostate Cancer (DIVINE Trial)

Phase 2

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

DIVINE Trial 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.Check my eligibility

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.See study design

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.

DIVINE Trial 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.

DIVINE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Modified radiographic progression-free survival (mrPFS)

Secondary outcome measures

Adverse event (AE) rate

Biologic progression-free survival (bPFS)

Overall survival (OS)

+2 more

DIVINE 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 ARPI (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

Positron Emission Tomography

2008

Completed Phase 2

~2240

Computed Tomography

2017

Completed Phase 2

~2720

Biospecimen Collection

2004

Completed Phase 2

~1700

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,227 Previous Clinical Trials

3,771,548 Total Patients Enrolled

34 Trials studying Prostate Cancer

8,388 Patients Enrolled for Prostate Cancer

Jacob J. Orme, M.D., Ph.D.Principal InvestigatorMayo Clinic in Rochester

2 Previous Clinical Trials

33 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"According to information available on clinicaltrials.gov, this particular trial is not actively seeking participants. The trial was originally listed on 5/1/2024 and underwent its latest revision on 4/16/2024. Despite the lack of current recruitment for this study, there are currently 2523 other trials in search of eligible individuals."

Answered by AI

Has Group B (SBRT, watchful waiting) received official approval by the FDA?

"In this Phase 2 trial, Group B's safety profile (SBRT, watchful waiting) has been assessed as a level 2 by our team at Power. This signifies that while some safety data exists, there is currently no evidence supporting its effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial

2024. "Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06378866.