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

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. Radia

Trial Details

NCT ID
NCT06499870
Phase
PHASE2
Sponsor
Sean Sachdev
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Biopsy
  • Biospecimen Collection
  • Computed Tomography
  • Enzalutamide
  • Fluorine F 18 Piflufolastat
  • Image Guided Radiation Therapy
Locations (sample)
  • Chicago, Illinois, United States|41.85003,-87.65005

Key Eligibility Criteria

  • Patients must have histologically confirmed prostate adenocarcinoma consistent with NCCN very-high-risk (VHR) prostate cancer defined with at least…
  • cT3b-cT4 (American Joint Committee on Cancer \[AJCC\] 9.0)
  • \> 4 cores with grade group 4 or 5 prostate cancer
  • Primary gleason pattern 5

For full eligibility, visit ClinicalTrials.gov.

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