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NCT07216248 · ClinicalTrials.gov registry record · Phase 2
Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
A Phase 2 study of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), sponsored by University of Utah.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT07216248: Recruiting Phase 2 study of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), sponsored by University of Utah.
NCT07216248 is a Phase 2 study of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) that is actively recruiting participants, run by University of Utah. The registered enrollment target is 160 participants, above the 51-participant average among 5 other Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) trials with a reported enrollment target (214% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07216248, a Phase 2 study of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), is actively recruiting participants, sponsored by University of Utah.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG relugolix + ARPI
- DRUG Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI
- DRUG relugolix or androgen deprivation therapy (ADT) + ARPI
- DRUG relugolix + ARPI.
Study Locations (1)
Utah
- Huntsman Cancer Institute at University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2025-10-27 |
| Est. Completion | 2031-10 |
| Phase | Phase 2 |
What NCT07216248 shows while recruiting
NCT07216248 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 51-participant average among 5 other Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) trials with a reported enrollment target (214% higher).
The record links to 1 condition, with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) appearing as the primary indexed condition, and to 4 interventions - of which relugolix + ARPI is the first listed.
NCT07216248 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT07216248 about?
NCT07216248 is a clinical study titled "Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer". 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.
What is the current status of trial NCT07216248?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2025-10-27. Estimated completion is 2031-10.
What conditions does trial NCT07216248 study?
This clinical trial studies the following conditions: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).
What interventions are being tested in trial NCT07216248?
The interventions under investigation include: relugolix + ARPI (DRUG), Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI (DRUG), relugolix or androgen deprivation therapy (ADT) + ARPI (DRUG), relugolix + ARPI. (DRUG).
Who is sponsoring clinical trial NCT07216248?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07216248 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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