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.
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
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
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Bone Scan
Procedure/SurgeryUndergo bone scan
Brachytherapy
RadiationUndergo brachytherapy
Computed Tomography
Procedure/SurgeryUndergo CT
Dual X-ray Absorptiometry
Procedure/SurgeryUndergo DEXA scan
External Beam Radiation Therapy
RadiationUndergo external beam radiation therapy
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
PSMA PET Scan
Procedure/SurgeryUndergo PSMA PET
Questionnaire Administration
Other interventionAncillary studies
Relugolix
DrugGiven PO
Biochemical recurrence
Will be defined as serum prostate-specific antigen (PSA) level of nadir + 2 ng/mL by blood test.
Composite quality of Life
Will be assessed by the Expanded Prostate Composite Index Short Form (EPIC-26) and will be compared between the 2 arms in terms of hormonal domain and sexual domain of EPIC-26. An area under the curve (AUC) metric will be utilized to account for the overall quality of life from baseline through 36 months for each patient. A mixed effect model will be employed to construct an estimate of the difference in AUC between Arms A and B, including fixed effects of time, arm, and baseline characteristics (two or three covariates depending on the available sample size). A two-sample t-test with a significance level of 0.05 will be performed.
Incidence of adverse events
Will be assessed by Common Terminology Criteria for Adverse Events version 5.0 and will be reported descriptively.
Incidence of major adverse cardiovascular events
Will be assessed by medical record review and will be reported descriptively.
Participant compliance
Will be assessed by patient study diary.
Click on the lead sponsor to view all of their trials.
University of Kansas Medical Center
Lead sponsor
University of Kansas
Sponsor institution
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
