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

PHASE2RecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

June 3, 2024

Primary Completion Date

May 31, 2029

Study Completion Date

May 31, 2029

Conditions
Recurrent Castration-Sensitive Prostate CarcinomaStage IVB Prostate Cancer AJCC v8Recurrent Prostate CancerCastration-resistant Prostate Cancer
Interventions
DRUG

Abiraterone

Given abiraterone

DRUG

Apalutamide

Given apalutamide

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Darolutamide

Given darolutamide

DRUG

Degarelix

Given degarelix

DRUG

Enzalutamide

Given enzalutamide

DRUG

Goserelin

Given goserelin

DRUG

Histrelin

Given histrelin

DRUG

Leuprolide

Given leuprolide

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Patient Observation

Undergo watchful waiting

PROCEDURE

Positron Emission Tomography

Undergo PET

DRUG

Prednisone

Given prednisone

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Relugolix

Given relugolix

RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

DRUG

Triptorelin

Given triptorelin

Trial Locations (2)

55905

RECRUITING

Mayo Clinic in Rochester, Rochester

85054

RECRUITING

Mayo Clinic in Arizona, Phoenix

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Mayo Clinic

OTHER

NCT06378866 - Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial | Biotech Hunter | Biotech Hunter