About this trial
This phase II trial evaluates the best duration for relugolix to be given in combination with radiation therapy when treating patients with high risk prostate cancer. Prostate cancer is a hormonal influenced cancer. Part of the usual treatment for patients with prostate cancer is androgen deprivation therapy (ADT). ADT is used to lower the amount of testosterone in the body, because testosterone appears to help prostate cancer grow. Relugolix works to reduce testosterone levels, which may inhibit proliferation of prostate cancer cells. It is approved by the Food and Drug Administration to treat prostate cancer. Adding relugolix to standard radiation therapy might work better and have fewer side effects than prior forms of hormonal therapy, but the optimal duration of relugolix in combination with radiation is not known.
Eligibility criteria
Qualifiers
Ability of participant or Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
Life expectancy > 5 years
Disqualifiers
Simultaneously enrolled in any therapeutic clinical trial
Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
Has a known allergic reaction to any excipient or component contained in the study drug formulation
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Bone Scan
- Brachytherapy
- Computed Tomography
- Dual X-ray Absorptiometry
- External Beam Radiation Therapy
- Magnetic Resonance Imaging
- PSMA PET Scan
- Questionnaire Administration
- Relugolix
Treatment groups
Locations
1Sponsors and collaborators
University of Kansas Medical Center
Lead sponsor
University of Kansas
Sponsor institution
National Cancer Institute (NCI)
Collaborator