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
Sponsors and collaborators
Sean Sachdev
Lead sponsor
Northwestern University
Sponsor institution
National Cancer Institute (NCI)
Collaborator