University of Utah
The purpose of this study is to evaluate intermittent relugolix + androgen receptor pathway inhibitor (ARPI) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) achieving optimal PSA response.
Inclusion Criteria: Cohort A Eligibility (Step 1 Registration) * Participant aged ≥ 18 years * Hormone-sensitive prostate cancer with histologically/cytologically confirmed adenocarcinoma without small cell histology. * Metastasis detected any time prior to study registration on conventional or functional imaging as determined by the treating investigator and can be of any site. * Baseline testosterone \>50 ng/dl before start of therapy for metastatic disease * PSA ≥ 1 ng/mL before start of therapy for metastatic disease * ECOG Performance Status ≤ 2 * Eligible to receive standard of care tr…
Step 1: Continuous treatment with relugolix + ARPI
Intermittent treatment with relugolix + ARPI.
Step 2: Standard-of-care, continuous treatment with relugolix or androgen deprivation therapy (ADT) + ARPI.
Step 2: Intermittent treatment with relugolix + ARPI.
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