NCT06499870View on ClinicalTrials.gov

Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 6, 2024

Primary Completion Date

November 19, 2028

Study Completion Date

November 19, 2032

Conditions
Prostate Adenocarcinoma
Interventions
PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Enzalutamide

Given PO

OTHER

Fluorine F 18 Piflufolastat

Undergo fluorine F 18 piflufolastat PET/MRI

RADIATION

Image Guided Radiation Therapy

Undergo IGRT

PROCEDURE

Magnetic Resonance Imaging

Undergo PET/MRI

PROCEDURE

Positron Emission Tomography

Undergo PET/MRI

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Relugolix

Given PO

Trial Locations (1)

60611

RECRUITING

Northwestern University, Chicago

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Northwestern University

OTHER