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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Sean Sachdev
Study ID
NCT06499870
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Prostate Adenocarcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Enzalutamide — DRUG
    Given PO
  • Fluorine F 18 Piflufolastat — OTHER
    Undergo fluorine F 18 piflufolastat PET/MRI
  • Image Guided Radiation Therapy — RADIATION
    Undergo IGRT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo PET/MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/MRI
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Relugolix — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Sep 6, 2024
Status verified
May 2026
Primary completion
Nov 19, 2030
Completion
Nov 19, 2032

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (relugolix, enzalutamide, IGRT)
    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.

Primary Outcome Measure

Pathologic response (biopsy positivity rate) [ Time Frame: At 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Study Coordinator
[email protected]
(312) 695-0990
Sean Sachdev, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern University· Chicago, IL

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