Trial · NCT07553988
Registered outcomes54
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 54
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Progression-free survival (PFS) at 1 year in RS-113 treatment arms | Up to day 337 (visit 16) | Progression-free survival (PFS) expressed as the median PFS for a period of up to 1 year of treatment inclusive in RS-113 treatment arms (per RECIST 1.1 and PCWG3 criteria) PFS is defined as the time from randomization to disease progression per RECIST 1.1 (an ≥ 20% increase in the sum of diameters of target lesions taking as reference the smallest sum recorded during the study (with an absolute increase of sum at least 5 mm), or the appearance of ≥ 1 new lesions), or death due to any cause According to PCWG3, progression is defined as: * two or more new lesions detected on the first post-baseline scan with at least 2 additional lesions on a subsequent scan * two or more new lesions detected on a subsequent scan (if one or no new lesions were seen at the first post-baseline scan) and confirmed by a follow-up scan |
| Secondary | Progression-free survival (PFS) rate (%) at 1 year in RS-113 treatment arms | Up to day 337 (visit 16) | Progression-free survival (PFS) expressed as the rate (%) at 1 year PFS in RS-113 treatment arms (per RECIST 1.1 and PCWG3 criteria) PFS is defined as the time from randomization to disease progression per RECIST 1.1 (an ≥ 20% increase in the sum of diameters of target lesions taking as reference the smallest sum recorded during the study (with an absolute increase of sum at least 5 mm), or the appearance of ≥ 1 new lesions), or death due to any cause According to PCWG3, progression is defined as: * two or more new lesions detected on the first post-baseline scan with at least 2 additional lesions on a subsequent scan * two or more new lesions detected on a subsequent scan (if one or no new lesions were seen at the first post-baseline scan) and confirmed by a follow-up scan |
| Secondary | Prostate-specific antigen (PSA) response rate (%) in RS-113 treatment arms | at Week 9, 21, 33, 45, 57, 69, 81, 93, 101 and FU visit | Prostate-specific antigen (PSA) response rate (%) in RS-113 treatment arms |
| Secondary | Number (%) of patients achieved ≥50% prostate-specific antigen (PSA) decline in RS-113 treatment arms | once at screening, on days 29 (visit 3), 57 (visit 5), 85-701 (visits 7-29) and FU visit | Number (%) of patients achieved ≥50% PSA decline at 6, 12, 18 and 24 months in RS-113 treatment arms Defined as a ≥50% reduction in PSA level from baseline at any time post-baseline. The response must be confirmed by the next PSA assessment performed at least 2 weeks later |
| Secondary | Number (%) of patients achieved ≥90% prostate-specific antigen (PSA) decline in RS-113 treatment arm | once at screening, on days 29 (visit 3), 57 (visit 5), 85-701 (visits 7-29) and FU visit | Number (%) of patients achieved ≥90% PSA decline at 6, 12, 18 and 24 months in RS-113 treatment arm Defined as a ≥90% reduction in PSA level from baseline at any time post-baseline. The response must be confirmed by the next PSA assessment performed at least 2 weeks later |
| Secondary | Objective response rate (ORR)(%) at 1 year in RS-113 treatment arms | once at screening, on days 57 (visit 5), 113 (visit 8), 169 (visit 10), 253 (visit 13), 337 (visit 16) and FU visit | The objective response rate (ORR)(%) is defined as the percentage of patients in RS-113 treatment arms who achieve a complete or partial response per RECIST 1.1: * Complete response (CR): disappearance of all target lesions confirmed by CT for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \< 10 mm * Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions sustained for at least 4 weeks taking as reference the baseline sum at screening |
| Secondary | Disease control rate (DCR)(%) at 1 year in RS-113 treatment arms | once at screening, on days 57 (visit 5), 113 (visit 8), 169 (visit 10), 253 (visit 13), 337 (visit 16) and FU visit | The disease control rate is defined as the percentage of patients in RS-113 treatment arms who achieve a complete response, partial response, or stable disease during treatment per RECIST 1.1: * Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \<10 mm * Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks taking as reference the baseline (screening) measurements * Stable Disease (SD) - neither sufficient shrinkage in the sum of diameters to qualify as partial response nor sufficient increase to qualify as progressive disease taking as reference the smallest sum recorded during the study |
| Secondary | Time to Tumor Response (TTR) at 1 year in RS-113 treatment arms | once at screening, on days 57 (visit 5), 113 (visit 8), 169 (visit 10), 253 (visit 13), 337 (visit 16) and FU visit | Time to Tumor Response (TTR) at 1 year in RS-113 treatment arms |
| Secondary | Duration of Response (DOR) at 1 year in RS-113 treatment arms | once at screening, on days 57 (visit 5), 113 (visit 8), 169 (visit 10), 253 (visit 13), 337 (visit 16) and FU visit | Duration of Response (DOR) at 1 year in RS-113 treatment arms |
| Secondary | Time to prostate-specific antigen (PSA) progression in RS-113 treatment arms | once at screening, on days 29 (visit 3), 57 (visit 5), 85-701 (visits 7-29) and FU visit | Time to PSA progression is the time from randomization to the earliest date of confirmed PSA progression (per PCWG3 criteria). The date of PSA progression is defined as the date of a documented ≥25% increase in PSA and an absolute increase of ≥2 ng/mL above the nadir (or above baseline for patients with no PSA decline by Week 12), confirmed by two consecutive values obtained at least 3 weeks apart |
| Secondary | Radiographic Progression-Free Survival (rPFS) at 1 year in RS-113 treatment arms | Up to day 337 (visit 16) | Radiographic Progression-Free Survival (rPFS) in RS-113 treatment arms, expressed as median rPFS for a period of up to 1 year of treatment inclusive (defined as the time from randomization to the first objective evidence of radiographic disease progression per RECIST 1.1 criteria or death due to any cause) |
| Secondary | Overall survival (OS) rate (%) at 1 year in RS-113 treatment arms | Up to day 337 (visit 16) | Overall survival (OS) expressed as the rate (%) at 1 year OS in RS-113 treatment arms |
| Secondary | Number of patients (%) with adverse drug reactions (ADRs) of any severity | Up to day 701 (visit 29) | Number of patients (%) with adverse drug reactions (ADRs) of any severity |
| Secondary | Number of patients (%) with adverse events (AEs) of any severity | Up to day 701 (visit 29) | Number of patients (%) with adverse events (AEs) of any severity |
| Secondary | Number of patients (%) with AEs grade ≥ 3 per CTCAE v. 5.0 | Up to day 701 (visit 29) | Number of patients (%) with AEs grade ≥ 3 per CTCAE v. 5.0 |
| Secondary | Number of patients (%) with ADRs grade ≥ 3 per CTCAE v. 5.0 | Up to day 701 (visit 29) | Number of patients (%) with ADRs grade ≥ 3 per CTCAE v. 5.0 |
| Secondary | Number of patients (%) with serious adverse events (SAEs) | Up to day 701 (visit 29) | Number of patients (%) with serious adverse events (SAEs) SAEs will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0 |
| Secondary | Number of patients (%) with serious adverse drug reactions (SADRs) | Up to day 701 (visit 29) | Number of patients (%) with serious adverse drug reactions (SADRs) SADRs will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0 |
| Secondary | Number of patients (%) who required discontinuation of treatment due to development of ADRs | Up to day 701 (visit 29) | Number of patients (%) who required discontinuation of treatment due to development of ADRs ADRs will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0 |
| Secondary | Number of patients (%) who required discontinuation of treatment due to development of SADRs | Up to day 701 (visit 29) | Number of patients (%) who required discontinuation of treatment due to development of SADRs SADRs will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0 |
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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