Trial · NCT07904026
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative incidence of participants who experience castration resistance, clinical relapse, or death in the 18-month trial period. | Enrollment to the end of follow up at 18 months. | Castration resistance will be defined as the time interval from treatment initiation to the first documented evidence of castration-resistant prostate cancer according to the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria defined as three consecutive rises in PSA at least 1 week apart, resulting in two 50% increases over the nadir, with a PSA \>2 ng/mL. Clinical relapse will be defined by soft tissue progression according to RECIST criteria, two or more new bone lesions on bone scan, or worsening symptoms attributable to prostate cancer. |
| Secondary | Time to PSA PFS defined as castration resistance, death, or clinical/radiographic progression | Enrollment to the end of follow up at 18 months. | Time to PSA PFS defined as castration resistance, clinical progression, or death. |
| Secondary | Number of participants transitioned to continuous ADT based on 2 consecutive rises in PSA of combined >0.2 at least 3 weeks apart | Enrollment to the end of follow up at 18 months. | Number of participants transitioned to continuous ADT |
| Secondary | Overall survival | Enrollment to the end of follow up at 18 months. | Overall survival: time from treatment initiation to death |
| Secondary | Quality of life based on Hot Flash-Related Daily Interference Scale (HFRDIS) | Day 1, Months 6, 12, and 18 | Scale from 0-10. Zero is equivalent to does not interfere and 10 is equivalent to completely interferes with specific aspects of life. |
| Secondary | Quality of life based on Functional Assessment of Cancer Therapy - Prostate (FACT-P) | Day 1, Months 6, 12, and 18 | The scoring system uses a 5-point Likert scale (from 0 to 4). The total score is calculated by summing the scores across all domains, providing a range of 0 to 156. Zero is equal to "Not at all", 1 is equal to "A little bit", 2 is equal to "Somewhat", 3 is equal to "Quite a bit", and 4 is equal to 'Very much". |
| Secondary | Number of GnRH agonist doses able to be skipped in the 18-month period | Enrollment to the end of follow up at 18 months. | Doses of GnRH skipped |
| Secondary | Number of participants able to skip >2 doses of GnRH agonist before testosterone becomes supra-castrate | Enrollment to the end of follow up at 18 months. | Doses of GnRH skipped |
| Secondary | Tumor growth via PSA kinetics | Day 1, Months 3, 6, 9, 12, 15, and 18. | PSA level ng/mL |
| Secondary | Time to non-castrate testosterone according to specific ADT and ARPI regimens | Day 1, Months 3, 6, 9, 12, 15, and 18. | Testosterone level ng/dL |
| Secondary | Correlation of duration of ADT plus ARPI therapy with time to non-castrate testosterone | Day 1, Months 3, 6, 9, 12, 15, and 18. | Testosterone level ng/dL |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT07904026/registered