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A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer

NCT07553988 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-28

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

RS-113, 160 mg

Hard gelatin capsules, 80 mg

DRUG

RS-113, 240 mg

Hard gelatin capsules, 80 mg

DRUG

RS-113, 320 mg

Hard gelatin capsules, 80 mg

DRUG

Abiraterone

Tablets, 250 mg

DRUG

Prednisolone

Tablets, 5 mg

DRUG

Androgen deprivation therapy (ADT)

* Goserelin: subcutaneous implant, 3.6 mg or 10.8 mg, or * Leuprorelin: lyophilisate for solution for subcutaneous injection, 7.5 mg or 22.5 mg, or * Triptorelin: lyophilisate for solution for intramuscular injection, 3.75 mg, or * Buserelin: lyophilisate for solution for intramuscular injection, 3.75 mg

Sponsors & Collaborators

  • R-Pharm International, LLC

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-24
Primary Completion
2026-05-14
Completion
2027-05-09

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07553988 on ClinicalTrials.gov