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Androgen Receptor Signaling Inhibitor

Relugolix + Enzalutamide with Radiation Therapy for Prostate Cancer

Phase 2

Recruiting

Led By Sean Sachdev

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Patients with known history of HIV must meet specific viral load and CD4 count criteria

Patients with cardiac disease history must have a clinical risk assessment better than class III

Must not have

Patients with prior radiotherapy resulting in overlap of radiation therapy fields

Patients with specific medical history exclusions including inflammatory bowel disease, symptomatic congestive heart failure, unstable angina, seizure disorder, psychiatric illness, repeated falls and fractures, or any condition that may compromise safety or study endpoints

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing how well a combination of relugolix and enzalutamide, along with radiation therapy, works in treating patients with very high risk prostate cancer. Relugolix

Who is the study for?

This trial is for patients with very high risk prostate cancer. Participants should be suitable for hormone therapy and radiation, have no prior treatments for their condition, and must be able to undergo imaging tests like MRI or CT scans.

What is being tested?

The OPTIMAL trial is testing the combination of two drugs, Relugolix and Enzalutamide, with radiation therapy. The goal is to see if this combo is more effective in treating very high risk prostate cancer than standard therapies.

What are the potential side effects?

Potential side effects include hot flashes, fatigue, joint pain from hormone therapy (Relugolix), seizures or spinal cord compression from Enzalutamide, and skin irritation or other typical reactions from radiation.

Eligibility Criteria

Inclusion Criteria

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

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I have HIV with controlled viral load and specific CD4 counts.

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My heart condition is not severe.

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I am 18 years old or older.

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I am able to get out of my bed or chair and move around.

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My prostate cancer is confirmed to be very high risk.

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My prostate cancer is classified as very high-risk based on its stage and grade.

Exclusion Criteria

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

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I have had radiotherapy where the treatment areas overlapped.

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I do not have conditions like severe heart issues, bowel disease, or mental illness that could risk my safety in the study.

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My cancer has spread to other parts of my body.

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I cannot take pills by mouth due to digestive issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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

Pathologic response (biopsy positivity rate)

Secondary study objectives

Disease-free survival

Testosterone recovery

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (relugolix, enzalutamide, IGRT)Experimental Treatment10 Interventions

Patients receive relugolix PO QD and enzalutamide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 18 months in the absence of disease progression or unacceptable toxicity. After 4 months of treatment with relugolix and enzalutamide, patients begin IGRT per standard of care. Patients also undergo fluorine F 18 piflufolastat PET/MRI and CT on the trial, undergo collection of blood samples throughout the trial, and undergo biopsy during follow up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Image Guided Radiation Therapy

2016

Completed Phase 2

~20

Computed Tomography

2017

Completed Phase 2

~2740