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NCT01790126 · ClinicalTrials.gov registry record · Phase 2
The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer
A Phase 2 study, sponsored by Aragon Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
NCT01790126: Completed Phase 2 study, sponsored by Aragon Pharmaceuticals.
NCT01790126 is a Phase 2 study that has completed, run by Aragon Pharmaceuticals. The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01790126, a Phase 2 study, has completed, sponsored by Aragon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
Study 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.
Primary Outcome
FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACT-General (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item pros
Interventions
- DRUG LHRH Agonist
- DRUG ARN-509
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2013-03-04 |
| Est. Completion | 2019-03-01 |
| Phase | Phase 2 |
What the finished NCT01790126 record still lists
NCT01790126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which LHRH Agonist is the first listed.
NCT01790126 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01790126 about?
NCT01790126 is a clinical study titled "The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer". 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 refle...
What is the current status of trial NCT01790126?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2013-03-04. Estimated completion is 2019-03-01.
What interventions are being tested in trial NCT01790126?
The interventions under investigation include: LHRH Agonist (DRUG), ARN-509 (DRUG).
Who is sponsoring clinical trial NCT01790126?
This trial is sponsored by Aragon Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01790126's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,199 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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