Trial · NCT07216248
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| 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. |
| Secondary | Time to systemic treatment change. | 12 months | 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 |
| Secondary | Duration of time on treatment | 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 | Time to first treatment restart | 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 | Duration of time with testosterone < 50 ng/mL | 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 | Testosterone-linked outcomes (time to recovery of testosterone ≥50 ng/dL; time to recovery of testosterone to baseline [≥screening testosterone level]). | 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 | Duration of time to recovery of testosterone to normal range [>300 ng/dL]). | 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 | The proportion of participants achieving a treatment-free interval (TFI) of at least one year from the time of registration and median TFI. | 12 months | To assess the TFI at one year in patients achieving optimal PSA response. |
| Secondary | Change in Brief Fatigue Inventory (BFI) score from baseline to 6 months after registration. | 6 months | To assess the change in quality of life measures from baseline. BFI Scored from 0 (no Fatigue) to 10 (as bad as you can imagine), and 0 (Does not interfere) to 10 (Completely Interferes). |
| Secondary | Changes in cognitive function as measured by the PROMIS-Cognitive Function Short Form 8a. | 13 months | To assess the change in quality of life measures from baseline. 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 intermittent arm with treatment break and start. | 13 months | To assess the change in quality of life measures from baseline. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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