Trial · NCT07553988
A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer
NCT07553988, Phase 2, Active not recruiting, R-Pharm International, LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer. Trials, record NCT07553988. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07553988
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer
- NCT number
- NCT07553988
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 120 participants, estimated
- Lead sponsor
- R-Pharm International, LLC
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Interventions
- RS-113, 160 mg, RS-113, 240 mg, RS-113, 320 mg, Abiraterone, Prednisolone, Androgen deprivation therapy (ADT)
- First posted
- 2026-04-28
- Last updated
- 2026-04-28
Source ClinicalTrials.gov
Registered outcomes54
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 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/NCT07553988
GET https://conductscience.org/api/trials/v1/NCT07553988/registered?page=2