Trial · NCT06582628
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PSA response (PSA50) | within the first 16 weeks | Percentage of participants with a PSA decline greater than or equal to 50 percent from baseline confirmed by a consecutive PSA value (taken at least 3 weeks apart), prior to PSA progression |
| Primary | Objective response rate (ORR) | during the first 16 weeks | Defined as the best overall radiographic response (partial or complete) during the first 16 weeks on follow up as per investigator assessment of soft tissue/visceral disease per RECIST 1.1 in subjects who have a measurable tumour and/or Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases |
| Secondary | Radiographic Progression Free Survival (rPFS) | Through study completion, an average of 2 years | Time from randomization to first objective evidence of radiographic progression, based on RECIST 1.1 for soft tissue/visceral disease and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines for bone metastases, or death, whichever occurs first. |
| Secondary | Time to PSA Progression (TTPP) | Through study completion, an average of 2 years | Time from randomization to PSA progression defined as PSA greater than or equal to 25 percent and greater than or equal to 2ng/mL from nadir (or baseline for participants with no PSA decline), confirmed by a second value obtained 3 or more weeks apart as per PCWG3 guidelines. |
| Secondary | Time to unequivocal clinical progression (TTCP) | Through study completion, an average of 2 years | Time from randomization to clinical worsening of prostate cancer related symptoms, as new onset cancer pain requiring chronic administration of opiate analgesia, deterioration from prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to 3 or higher, time to first skeletal-related event (the time from randomization to first incidence of radiotherapy to the bone or bone surgery, pathological bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain); or initiation of subsequent lines of active treatment including cytotoxic chemotherapy or radiation therapy or surgical intervention due to complications or symptoms related to disease progression. |
| Secondary | Progression Free Survival (PFS) | Through study completion, an average of 2 years | Time from randomization to PSA progression, unequivocal clinical progression or radiographic progression, whichever occurs first. |
| Secondary | Incidence of adverse events (AEs) | Through study completion, an average of 2 years | Total, grouped by grades and AEs category, related and unrelated with the trial treatment. The AEs Defined as incidence of prespecified AEs as per National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, change from baseline in targeted vital signs and change from baseline in targeted clinical laboratory test results. |
| Secondary | Incidence of serious adverse events (SAEs) | Through study completion, an average of 2 years | Number of Serious Adverse Events, related and unrelated. SAEs leading to treatment discontinuation. |
| Secondary | Drug compliance | Through study completion, an average of 2 years | Percentage of dose taken for each treatment drug, dose reductions, dose discontinuation (temporary or permanent) |
| Other | Assessment of PSA response rate | Through study completion, an average of 2 years | In participants with and without germline and/or somatic DDR alterations. |
| Other | Assessment of ORR | Through study completion, an average of 2 years | In participants with and without germline and/or somatic DDR alterations |
| Other | Assessment of rPFS | Through study completion, an average of 2 years | In participants with and without germline and/or somatic DDR alterations |
| Other | Assessment of TTPP | Through study completion, an average of 2 years | In participants with and without germline and/or somatic DDR alterations. |
| Other | Assessment of TTCP | Through study completion, an average of 2 years | In participants with and without germline and/or somatic DDR alterations. |
| Other | Changes in expression levels of AR in tissue | Through study completion, an average of 2 years | Changes from tissue samples, studying the correlation of these changes with clinical activity |
| Other | Changes in expression levels of AR in plasma | Through study completion, an average of 2 years | Changes from plasma samples, studying the correlation of these changes with clinical activity |
| Other | Changes in expression of AR-related genes in tissue | Through study completion, an average of 2 years | Changes from tissue samples, studying the correlation of these changes with clinical activity |
| Other | Changes in expression of AR-related genes in plasma | Through study completion, an average of 2 years | Changes from plasma samples, studying the correlation of these changes with clinical activity |
| Other | Changes in open chromatin regions in tissue | Through study completion, an average of 2 years | Changes from tissue samples, studying the correlation of these changes with clinical activity |
| Other | Changes in open chromatin regions in plasma | Through study completion, an average of 2 years | Changes from plasma samples, studying the correlation of these changes with clinical activity |
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/NCT06582628/registered