Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Participant received androgen deprivation therapy (defined as leuprolide or surgical castration) for metastatic hormone-sensitive prostate cancer.
The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.
Known brain metastases or cranial epidural disease.
Current evidence of uncontrolled, significant intercurrent illness, infection, non-compliance or other safety concerns which may affect clinical trial participation.
Trial design
Treatments tested in this trial
- relugolix + ARPI
- Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI
- relugolix or androgen deprivation therapy (ADT) + ARPI
- relugolix + ARPI.
Treatment groups
160 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov