Clinical trial NCT01193855 (phase 2, status: unknown status)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: dutasteride, gadolinium-chelate
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C
Eligibility 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