Dutasteride in Treating Patients With Prostate Cancer

This is an interventional treatment trial for Prostate Cancer focused on measuring stage IIB prostate cancer, stage IIA prostate cancer Read More

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