NCT07553988 RS-113 Metastatic castration-resistant prostate cancer Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07553988 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 24 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07553988 is a hot trial to watch
Metastatic castration-resistant prostate cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07553988 is notable because it evaluates RS-113 in a Phase 2 design sponsored by R-Pharm International LLC. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07553988 |
| Official title | A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer |
| Phase / status | Phase 2 / Active, not recruiting |
| Intervention | RS-113 |
| Sponsor | R-Pharm International LLC |
| Geography | Russia |
| Enrollment | [object Object] |
| Primary endpoint | Median Progression-free survival (PFS) at 1 year in RS-113 treatment arms |
| Endpoint time frame | Up to day 337 (visit 16) |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The primary objective of the study is to determine the therapeutic dose of RS-113 in patients with metastatic castration-resistant prostate cancer based on efficacy, safety, and pharmacokinetic parameters. The secondary objectives are to assess a pilot efficacy and safety of different doses of RS-113 versus abiraterone, as well as to investigate pharmacokinetics profile and to perform a pilot evaluation of pharmacokinetics parameters of RS-113 in patients with metastatic castration-resistant prostate cancer
Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across Russia shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- 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 le
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: RS-113 is indexed as Small molecule drug, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status Phase 2.
Company & Deal Intelligence MCP profile: R-Pharm International LLC is resolved to a normalized organization record in United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07553988 provides a focused lens on Metastatic castration-resistant prostate cancer development. Its value will be determined by whether RS-113 can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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