CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Rucaparibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03413995
NCT03413995Phase 2Completed

Phase II Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations (TRIUMPH)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Jan 29, 2018·Updated Oct 16, 2024

In Brief

A Phase 2 clinical trial evaluating Rucaparib for Prostate Cancer Metastatic. Completed, enrolled 12 participants across 2 sites.

Detailed Summary

The aim of this research is to find out if the study drug rucaparib leads to lowering of PSA levels in men with metastatic prostate cancer that has not yet been treated with androgen deprivation therapy (also referred to as metastatic hormone sensitive prostate cancer) and who have an inherited mutation in a gene involved in repairing DNA damage. The research will also examine if rucaparib is safe in individuals with metastatic prostate cancer. Prior research studies have shown that drugs like rucaparib can be of benefit to patients with advanced metastatic prostate cancer who are resistant to androgen deprivation therapy AND who carry a mutation in a DNA repair gene. We are studying if rucaparib will be an effective treatment for these patients earlier in their treatment course (for example, prior to the start of medicines that lower testosterone level). It is unknown whether rucaparib will have the same benefit in men with metastatic prostate cancer carrying a mutation in a DNA repair gene, prior to the use of medicines that lower your testosterone level.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 29, 2018
Enrollment StartSep 10, 2018
Primary CompletionNov 8, 2023
Study CompletionSep 12, 2024
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 8.4 years ago

Interventions

Rucaparibdrug

Continuous dosing