Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer

NCT07216248 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HCI194008
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Outcome Measures

Primary Outcomes (2)

• Cohort A: Brief Fatigue Inventory (BFI) score 6 months after randomization.

  To assess the difference in fatigue 6 months after randomization in patients with mHSPC achieving optimal PSA response on intermittent relugolix + ARPI versus continuous relugolix/ADT + ARPI. Scored from 0 (no Fatigue) to 10 (as bad as you can imagine), and 0 (Does not interfere) to 10 (Completely Interferes).

  6 months

• Cohort B: Progression-free survival (PFS) as defined as the time from intermittent study initiation (first treatment break) to the time of documented disease progression or death from any cause at one year.

  To assess PFS in patients with mHSPC on intermittent relugolix + ARPI at one year.

  12 months

Secondary Outcomes (19)

• Changes in health-related quality of life as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC-QLQC30).

  13 months

• Changes in health-related quality of life as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC-QLQ-PR25).

  13 months

• Sexual function improvement in those with intact sexual function at baseline as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire.

  13 months

• Changes in severity of hot flashes as measured by the Hot Flash Related Daily Interference Scale (HFRDIS).

  13 months

• Changes in cognitive function as measured by the PROMIS-Cognitive function Short Form 8a.

  13 months

Study Arms (3)

Cohort A: Arm 1

ACTIVE COMPARATOR

INDUCTION (Step 1): Participants will receive continuous treatment with relugolix + an androgen receptor pathway inhibitor (ARPI). After 6-12 months of continuous treatment, participants whose PSA is ≤ 0.2 ng/mL and who have completed step two registration will be randomized to one of two treatment arms: • Cohort A: Arm 1 will continue standard-of-care, continuous treatment with relugolix or androgen deprivation therapy (ADT) + ARPI per clinical investigator.

Drug: relugolix + ARPI; Drug: relugolix or androgen deprivation therapy (ADT) + ARPI

Cohort A: Arm 2

EXPERIMENTAL

INDUCTION (Step 1): Participants will receive continuous treatment with relugolix + an androgen receptor pathway inhibitor (ARPI). After 6-12 months of continuous treatment, participants whose PSA is ≤ 0.2 ng/mL and who have completed step two registration will be randomized to one of two treatment arms: • Cohort A: Arm 2 will receive intermittent treatment with relugolix + ARPI.

Drug: relugolix + ARPI; Drug: relugolix + ARPI.

Cohort B

EXPERIMENTAL

Participants who have achieved PSA ≤ 0.2 ng/mL are eligible and will receive intermittent treatment with relugolix + ARPI.

Drug: Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI

Interventions

relugolix + ARPI. DRUG

Step 2: Intermittent treatment with relugolix + ARPI.

Cohort A: Arm 2

Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI DRUG

Intermittent treatment with relugolix + ARPI.

Cohort B

relugolix or androgen deprivation therapy (ADT) + ARPI DRUG

Step 2: Standard-of-care, continuous treatment with relugolix or androgen deprivation therapy (ADT) + ARPI.

Cohort A: Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 of any site.
• Baseline testosterone \>50 ng/dl before start of therapy for metastatic disease
• PSA ≥ 1 ng/mL
• 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.

You may not qualify 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 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Interventions

relugolix; Androgen Antagonists

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Erynn Peyton

CONTACT

801-213-5601; Erynn.Peyton@hci.utah.edu

Umang Swami, MD

CONTACT

801-585-0255; Umang.Swami@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 14, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2031
• Last Updated: October 29, 2025

Record last verified: 2025-10

Locations

US (1)