Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
A Phase II Randomized, Decentralized, De-escalation Study in Patients With Metastatic Hormone-Sensitive Prostate Cancer Achieving Optimal PSA Response (OPTIMAS)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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 treatment with relugolix and APRI per clinical investigator. * Participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception requirements as described in Section 5.5.1. * If the risk of seminal transfer from the participant is present, the participant must agree to use a condom during sexual intercourse as described in Section 5.5.2. * Participants must agree not to donate sperm from the start of study therapy until 3 months after the last dose of study therapy. * Clinically significant adverse effects from any prior oncologic treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy) must have resolved or have been determined to be clinically stable per the Investigator. * Has access to a smartphone and wireless services and is able to download and navigate study specific applications. * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. Cohort A Eligibility (Step 2 Registration) -PSA ≤ 0.2 ng/mL after 6-12 months of relugolix and androgen receptor pathway inhibitor treatment. Androgen receptor pathway inhibitor includes abiraterone, enzalutamide, apalutamide, darolutamide or similar drugs. Cohort B Eligibility * 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 clinical investigator and can be of any site. * PSA ≤ 0.2 ng/mL after treatment with androgen deprivation therapy or androgen receptor pathway inhibitor treatment or both of any duration. Androgen deprivation therapy in this context includes gonadotropin-releasing hormone agonists and antagonists. Androgen receptor pathway inhibitors include abiraterone, enzalutamide, apalutamide, darolutamide or similar drugs. * Eligible to receive standard of care treatment with relugolix and APRI per clinical investigator. * Participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception requirements as described in Section 5.5.1. * If the risk of seminal transfer from the participant is present, the participant must agree to use a condom during sexual intercourse as described in Section 5.5.2. * Participants must agree not to donate sperm from the start of study therapy until 3 months after the last dose of study therapy. * Has access to a smartphone and wireless services and is able to download and navigate study specific applications. * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. Exclusion Criteria: Cohort A Eligibility (Step 1 Registration) * 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. --Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Participants must be neurologically stable and receiving a stable or decreasing corticosteroid dose at the time of study entry. * Current evidence of uncontrolled, significant intercurrent illness, infection, non-compliance or other safety concerns which may affect clinical trial participation. * Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study. * Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v5.0 Grade ≥ 3). * Participants taking prohibited medications as described in Section 6.6.2. Cohort A Eligibility (Step 2 Registration) * Receiving other systemic anti-cancer therapy for prostate cancer. Prior treatment before Step 2 registration is allowed. * Progression to metastatic castration-resistant prostate cancer per clinical investigator. * 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. * Participants taking prohibited medications as described in Section 6.6.2. Cohort B Eligibility * Receiving other systemic anti-cancer therapy for prostate cancer. * History of surgical castration. * 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. --Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Participants must be neurologically stable and receiving a stable or decreasing corticosteroid dose at the time of study entry * Current evidence of uncontrolled, significant intercurrent illness, infection, compliance or other safety concerns which may affect clinical trial participation. * Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study. * Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v5.0 Grade ≥ 3). * Participants taking prohibited medications as described in Section 6.6.1.
Study sites (1)
UT
- Huntsman Cancer Institute at University of Utah · Salt Lake City, UT 84112Erynn Peyton · Study contact · 801-213-5601 · Erynn.Peyton@hci.utah.eduUmang Swami, MD · Study contact · 801-585-0255 · Umang.Swami@hci.utah.eduMore trials in Salt Lake City