Trial · NCT07216248
Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
NCT07216248, Phase 2, Recruiting, University of Utah
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer. Trials, record NCT07216248. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07216248
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
- NCT number
- NCT07216248
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 160 participants, estimated
- Lead sponsor
- University of Utah
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- Interventions
- relugolix + ARPI, Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI, relugolix or androgen deprivation therapy (ADT) + ARPI, relugolix + ARPI.
- First posted
- 2025-10-14
- Last updated
- 2026-11-09
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohort A: Brief Fatigue Inventory (BFI) score 6 months after randomization. | 6 months | 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). |
| Primary | 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. | 12 months | To assess PFS in patients with mHSPC on intermittent relugolix/ADT + ARPI at one year. |
| Secondary | 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 | To evaluate treatment effects on patient-reported outcomes (PROs). EORTC-QLQC30 scored from 1 (not at all)- 4 (very much). |
| Secondary | 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 | To evaluate treatment effects on patient-reported outcomes (PROs). EORTC-QLQ-PR25 scored from 1 (not at all)- 4 (very much). |
| Secondary | 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 | To evaluate treatment effects on patient-reported outcomes (PROs). EORTC-QLQ-PR25, question 52-55.Scored from 1 (not at all)- 4 (very much). |
| Secondary | Changes in severity of hot flashes as measured by the Hot Flash Related Daily Interference Scale (HFRDIS). | 13 months | To evaluate treatment effects on patient-reported outcomes (PROs). HFRDIS scored 0 (did not interfere to 10 (completely interfered). |
| Secondary | Changes in cognitive function as measured by the PROMIS-Cognitive function Short Form 8a. | 13 months | To evaluate treatment effects on patient-reported outcomes (PROs). PROMIS-Cognitive function Short Form 8a scored 5 (Never)- 1 (very often- Several times a day). |
| Secondary | Change from baseline over time in each PRO, including time to recovery and deterioration in the intermittent arm with treatment break and start. | 2 years | To evaluate treatment effects on patient-reported outcomes (PROs). |
| Secondary | Time to metastatic castration-resistant prostate cancer. | 12 months | Cohort A: To determine if intermittent relugolix + ARPI will provide similar efficacy as continuous relugolix/ADT + ARPI in clinically relevant endpoints in participants with mHSPC who reached PSA ≤0.2 ng/mL after 6-12 months of relugolix+ARPI treatment. Cohort B: To evaluate the treatment efficacy of intermittent relugolix/ADT + ARPI. |
| Secondary | Overall survival and prostate cancer-specific survival at 3 years from the date of randomization. | 12 months | Cohort A: To determine if intermittent relugolix + ARPI will provide similar efficacy as continuous relugolix/ADT + ARPI in clinically relevant endpoints in participants with mHSPC who reached PSA ≤0.2 ng/mL after 6-12 months of relugolix+ARPI treatment. Cohort B: Change from baseline over time in each PRO, including time to recovery and deterioration in intermittent arm with treatment break and start. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07216248
GET https://conductscience.org/api/trials/v1/NCT07216248/registered?page=2