Trials / Completed
CompletedNCT01790126
The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Aragon Pharmaceuticals, Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ARN-509 | |
| DRUG | LHRH Agonist |
Timeline
- Start date
- 2013-03-04
- Primary completion
- 2019-03-01
- Completion
- 2019-03-01
- First posted
- 2013-02-13
- Last updated
- 2020-03-11
- Results posted
- 2020-03-11
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01790126. Inclusion in this directory is not an endorsement.