Quantifying Optimal Relugolix Duration With Radiation in High Risk Prostate Cancer (QURE-PC)
University of Kansas Medical Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. To compare the biochemical recurrence rate between 12 and 24 months of relugolix in patients with high risk prostate cancer treated with combination external beam radiation and brachytherapy. SECONDARY OBJECTIVES: I. To compare the composite quality of life in patient treated with 12 months and 24 months of relugolix as assessed by the Expanded Prostate Composite Index Short Form (EPIC-26) instrument. II. To compare the treatment related toxicity between 12 months and 24 months of relugolix as assessed by Common Terminology Criteria for Adverse Events version 5.0. (CT…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Patient diagnosed with National Comprehensive Cancer Network (NCCN) high risk and very high risk prostate cancer. * High risk is defined as: * T3a or * Grade group 4 or 5 or * Prostate-specific antigen (PSA) \> 20 ng/mL * Very high risk is defined as: * T3b to T4 or * Pr…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Scan
Undergo bone scan
- RadiationBrachytherapy
Undergo brachytherapy
- ProcedureComputed Tomography
Undergo CT
- ProcedureDual X-ray Absorptiometry
Undergo DEXA scan
- RadiationExternal Beam Radiation Therapy
Undergo external beam radiation therapy
- ProcedureMagnetic Resonance Imaging
Location
- University of Kansas Cancer CenterKansas City, Kansas