RecruitingPhase 2NCT06499870

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

Optimizing Treatment and Advanced Multi-Imaging Response Evaluation for Very-High-Risk Prostate Cancer (OPTIMAL) - a Phase II Single Arm Study


Sponsor

Northwestern University

Enrollment

50 participants

Start Date

Sep 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well relugolix and enzalutamide, in combination with radiation therapy, works in treating patients with very high risk prostate cancer. Relugolix is a form of androgen deprivation therapy. It prevents the release of testosterone, a hormone required to sustain prostate growth. Reducing testosterone levels may inhibit the proliferation of prostate tumor cells that need testosterone to grow. Enzalutamide is an androgen receptor signaling inhibitor. It inhibits the activity of prostate tumor cell receptors, which may reduce proliferation of prostate tumor cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Adding relugolix and enzalutamide to radiation therapy may be more effective at treating patients with very high risk prostate cancer than giving any of these treatments alone.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called OPTIMAL) is testing whether combining the hormone-blocking drugs relugolix and enzalutamide with radiation therapy produces better outcomes than standard hormone therapy plus radiation for men with very high-risk prostate cancer. **You may be eligible if...** - You are 18 or older with biopsy-confirmed prostate adenocarcinoma meeting NCCN "very-high-risk" criteria (advanced stage, high-grade cancer, or multiple high-risk features) - Pelvic lymph node involvement is allowed, provided it is below a certain level - Your testosterone level is above the normal threshold at enrollment - Your general health and organ function are adequate for treatment **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic disease) - You have already received hormone therapy for prostate cancer (some short-term exceptions may apply) - You have serious heart conditions or other illnesses that would make the treatment unsafe - You are unable to comply with radiation therapy appointments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREComputed Tomography

Undergo CT

DRUGEnzalutamide

Given PO

OTHERFluorine F 18 Piflufolastat

Undergo fluorine F 18 piflufolastat PET/MRI

RADIATIONImage Guided Radiation Therapy

Undergo IGRT

PROCEDUREMagnetic Resonance Imaging

Undergo PET/MRI

PROCEDUREPositron Emission Tomography

Undergo PET/MRI

OTHERQuestionnaire Administration

Ancillary studies

DRUGRelugolix

Given PO


Locations(1)

Northwestern University

Chicago, Illinois, United States

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NCT06499870


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