Dutasteride in Treating Patients With Prostate Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed prostate cancer, meeting all of the following criteria:
• •* Prostate-specific antigen (PSA) \< 10.0 ng/mL
• •* T1c-T2a disease
• •* Gleason sum of 6 or 7 (secondary pattern 4 only)
• •Patients with low risk disease must meet the following criteria:
• •* Gleason pattern 3 + 3
• •* PSA \< 10.0 ng/mL
• •* Clinical T2a disease
• •Patients with Gleason secondary pattern 4 (i.e., Gleason Pattern 3 + 4) are eligible but must not have a primary pattern 4, PSA \> 10 ng/mL, or clinical T2b disease
• •Measurable disease on MRI of at least 0.2 cc, based on planimetry volume
• •Biopsy-proven disease within 2 years of screening visit
• •* No biopsy artifact on MRI scan (minimum 12-week interval between biopsy and baseline MRI)
• •Eligible for active surveillance according to the criteria set out by the National Institute for Health and Clinical Excellence
• •PATIENT CHARACTERISTICS:
• •ALT and AST ≤ 2 times the upper limit of normal (ULN)
• •Alkaline phosphatase ≤ 2 times ULN
• •Bilirubin ≤ 1.5 times ULN
• •Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min
• •Able to swallow and retain oral medication
• •Able and willing to participate in the study for its duration
• •Able to read and write (health-outcomes questionnaires are written)
• •Able to understand instructions related to study procedures and give written informed consent
• •No history of another malignancy within five years that could affect the diagnosis of prostate cancer
• •No history or current evidence of drug or alcohol abuse within the last 12 months that might confound the results of the study or pose additional risk to the patient
• •No known hypersensitivity to any 5α-reductase inhibitor or to any drug chemically related to dutasteride
• •No contraindication for undergoing gadolinium-enhanced MRI, including any of the following:
• •* Inability to see tumor focus of ≥ 0.2 cc on T2 sequences
• •* Previous allergic reaction to gadolinium
• •* Serum creatinine \> ULN
• •* Incompatible pacemaker
• •* Metal fragments in eyes
• •* Hip replacements that give artifact with prostate/pelvis views
• •* Any artifact or condition that reduces image quality of MRI (e.g., inability to keep still)
• •No unstable serious co-existing medical condition(s) including, but not limited, to any of the following:
• •* Myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening visit
• •* Uncontrolled diabetes
• •* Peptic ulcer disease uncontrolled by medical management
• •PRIOR CONCURRENT THERAPY:
• •No prior radiotherapy (external-beam or brachytherapy), high-intensity focused ultrasound (HIFU), or photodynamic therapy (PDT)
• •No prior chemotherapy
• •At least 3 months since prior and no concurrent prostatic surgery, including TUNA, TURP, TUIP, laser treatment, thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation
• •No prior oral glucocorticoids
• •* Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to visit one
• •No prior GnRH analogues (e.g., leuprolide, goserelin)
• •No prior or concurrent hormonal treatment (e.g., megestrol, medroxyprogesterone, cyproterone, DES) of prostate cancer
• •No current and/or prior use of the following medications:
• •* Finasteride (Proscar, Propecia), or dutasteride (GI198745, AVODART) exposure within 12 months prior to study entry
• •* Any other investigational 5α-reductase inhibitors within the past 12 months
• •* Anabolic steroids within the past 6 months
• •* Drugs with antiandrogenic properties within the past 6 months (e.g., spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents)
• •* The use of cimetidine is permitted prior to study entry
• •* The use of topical ketoconazole is permitted prior to and during the study
• •No participation in another investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period