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New treatment option for Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Official title Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
ClinicalTrials.gov ID: NCT07216248
What this study is testing
What is relugolix + ARPI?
relugolix + ARPI is an investigational medicine, being studied as a potential treatment for metastatic hormone-sensitive prostate cancer (mhspc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Baseline testosterone \>50 ng/dl before start of therapy for metastatic disease
You likely can't join if
- 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...
- Known brain metastases or cranial epidural disease. --Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or...
- Current evidence of uncontrolled, significant intercurrent illness, infection, non-compliance or other safety concerns which may affect clinical...
- Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.