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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorSean Sachdev

About this 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. 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 criteria

Qualifiers

cT3b-cT4 (American Joint Committee on Cancer [AJCC] 9.0)

> 4 cores with grade group 4 or 5 prostate cancer

Primary gleason pattern 5

2 or 3 NCCN high-risk features.

Disqualifiers

Patients with definitive clinical or radiologic evidence of metastatic disease

Patients with prior invasive malignancy (except non-melanomatous skin cancer carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years

Prior radiotherapy that would result in overlap of radiation therapy fields

History of documented inflammatory bowel disease

Trial design

Treatments tested in this trial

  • Biopsy
  • Biospecimen Collection
  • Computed Tomography
  • Enzalutamide
  • Fluorine F 18 Piflufolastat
  • Image Guided Radiation Therapy
  • Magnetic Resonance Imaging
  • Positron Emission Tomography
  • Questionnaire Administration
  • Relugolix

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sean Sachdev

Lead sponsor

Northwestern University

Sponsor institution

National Cancer Institute (NCI)

Collaborator