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Complete title: The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men with Biochemically Relapsed Hormone Sensitive Prostate Cancer
|Research Study Number||20130917|
|Principal Investigator||Tia Higano, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Male
Key Inclusion Criteria:
- 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
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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
Other exclusion criteria may apply.
Prostate Cancer; Solid Tumors
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