CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
ARN-509 +1 moredrug
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/NCT01790126
NCT01790126Phase 2Completed

The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer

Aragon Pharmaceuticals, Inc.·interventional·Posted Feb 13, 2013·Updated Mar 11, 2020

In Brief

A Phase 2 clinical trial evaluating ARN-509 and LHRH Agonist for Prostate Cancer. Completed, enrolled 90 participants across 5 sites.

Detailed Summary

The proposed clinical trial will study the effects of 12 months of therapy with ARN-509 alone, or in combination with an LHRH agonist (LHRHa), each compared with LHRHa alone, in men with a rapidly rising serum PSA after prior definitive local therapy for prostate cancer. The endpoints selected reflect measurable short term effects of androgen deprivation therapy (ADT), including quality of life and several metabolic parameters. In addition, the relative effect of each treatment strategy on PSA suppression as well as testosterone recovery (and subsequent PSA progression) after 12 months of therapy will be evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 13, 2013
Enrollment StartMar 4, 2013
Primary CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 13.4 years ago

Interventions

ARN-509drug

LHRH Agonistdrug