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Prostate Cancer Clinical Trials

ARN-509 for Relapsed Hormone Sensitive Prostate Cancer (20130917)
The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men with Biochemically Relapsed Hormone Sensitive Prostate Cancer
Status Conditions Phase Study ID
Recruiting Prostate Cancer Phase II 20130917
NCT01790126
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 to 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.


Investigator
Tia Higano, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Histologically proven adenocarcinoma of the prostate
  • Rising PSA after prior definitive local therapy (radical prostatectomy, external beam radiation, or brachytherapy) or combination of radical prostatectomy and radiotherapy with curative intent
  • PSA doubling time less than or equal to 12 months
  • No evidence of metastatic disease by CT/MRI abdomen/pelvis and whole body bone scan
  • Minimum PSA 1.0 ng/mL if prior radical prostatectomy +/- adjuvant or salvage radiation; nadir + 2.0 ng/mL if prior RT without prior radical prostatectomy
  • No androgen deprivation therapy or anti-androgen (i.e. bicalutamide) within 12 months of study entry
  • No prior androgen deprivation therapy (ADT) or anti-androgen for biochemical relapse
  • Serum testosterone > 150 ng/dL at study entry
  • No history of seizures or medical conditions which may lower seizure threshold
Exclusions (conditions that would prevent participation in this study)
  • Use of 5-alpha reductase antagonist (i.e. finasteride, dutasteride) within 3 months of study entry
  • Use of antiandrogen (e.g. flutamide, nilutamide, bicalutamide) within 12 months of study entry
  • Prior bilateral orchiectomy
  • Prior hormonal treatment with ADT or antiandrogen for biochemically relapsed prostate cancer
  • Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher at the time of study entry
  • Any history of seizures or medical condition which lowers seizure threshold
Last Updated
September 17, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.