Prostate Cancer Clinical Trials
|Recruiting||Prostate Cancer||Phase II||
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.
- 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
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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