Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Kansas Medical Center

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

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Kansas Medical Center

Lead sponsor

University of Kansas

Sponsor institution

National Cancer Institute (NCI)

Collaborator