Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men
Condition: Neoplasms, Prostate
MeSH terms: Prostatic Neoplasms
Intervention: Dutasteride; Matching placebo
Intervention description: Dutasteride 0.5mg; Matching placebo
Intervention MeSH terms: Dutasteride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 302.0
Sex: Male
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Dutasteride Prostate Cancer Expectant management REDEEM

Summary:

      The purpose of this study is to examine the effect of dutasteride on the inhibition of
      low-risk, localized prostate cancer progression in men who would otherwise receive no active
      therapy (expectant management).
    

Eligibility criteria:

        Inclusion criteria:

          -  Must be male ≥48 and ≤82 years of age

          -  Have biopsy proven, low-risk, localized prostate cancer and active in expectant
             management not more than 14 months. [For the purposes of assessing subject eligibility
             a diagnostic biopsy must have included at least 10 cores, (< 4 cores positive and <50%
             of any one core positive) and must have been obtained within 8 months of screening].
             If a saturation biopsy was performed (20 or more cores obtained) 2-3 cores are to be
             positive for prostate cancer and with <50% of any one core positive. Initial diagnosis
             of T1a/T1b obtained during a Transrectal ultrasound (TURP) is not allowed.

          -  Gleason score ≤6 [Gleason pattern 4 or above must not be present on any biopsy
             (initial or entry)]

          -  Clinical stage T1c-T2a

          -  Serum Prostate Specific Antigen (PSA) ≤11ng/mL. If the screening PSA value from the
             central laboratory is greater than 11ng/ml, one PSA retest is allowed through the
             central laboratory

          -  A life expectancy greater than five years.

          -  Able to swallow and retain oral medication

          -  Able and willing to participate in the full 3 years of the study

          -  Able to read and write (health outcomes questionnaires are self-administered),
             understand instructions related to study procedures and give written informed consent.

        Exclusion criteria:

          -  Subject has ever been treated for prostate cancer with any of the following:

          -  Radiotherapy (external beam or brachytherapy)

          -  Chemotherapy

          -  Hormonal therapy (e.g., megestrol, medroxyprogesterone, cyproterone,
             diethylstilbestrol (DES)

          -  Oral glucocorticoids

          -  Gonadotropin-releasing hormone (GnRH) analogues (e.g., leuprolide, goserelin)

          -  Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to
             visit one

          -  Current and/or previous use of the following medications:

          -  Finasteride (Proscar, Propecia), or Dutasteride (GI198745, AVODART) exposure within 6
             months prior to study entry are excluded.

          -  Any other investigational 5α-reductase inhibitors within the past 12 months.

          -  Anabolic steroids (subject must discontinued for 6 months prior to study entry to be
             eligible)

          -  Drugs with antiandrogenic properties within the past 6 months (e.g,. spironolactone,
             flutamide, bicalutamide, *cimetidine, *ketoconazole, metronidazole, progestational
             agents) NOTE: Use of dietary and herbal supplements (e.g., selenium, Vitamin E, saw
             palmetto) during the study is discouraged but not prohibited. All dietary and herbal
             supplement usage will be recorded in the case report form (CRF).

             *The use of cimetidine is permitted prior to study entry. The use of topical
             ketoconazole is permitted prior to and during the study.

          -  Prostate volume >80 cc

          -  Subject has had prior prostatic surgery including Transurethral needle ablation of the
             prostate (TUNA), TURP, Transurethral incision of the prostate (TUIP), laser treatment,
             thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation within 3 months
             of enrolment

          -  Severe Benign Prostatic Hyperplasia (BPH) symptoms as manifested by International
             Prostate Symptom Score (IPSS) symptom score (calculated using the first 7 questions
             only) of ≥25 or >20 if already on alpha blocker therapy.

          -  Participation in any investigational or marketed drug trial within the 30 days prior
             to the first dose of study drug or anytime during the study period.

          -  Any unstable serious co-existing medical condition(s) including but not limited to
             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 or peptic ulcer disease which
             is uncontrolled by medical management.

          -  Abnormal liver function test (greater than 2 times the upper limit of normal for
             alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline
             phosphatase [ALP]); or bilirubin >1.5 times the upper limit of normal.

          -  Serum creatinine >1.5 times the upper limit of normal.

          -  History of another malignancy within five years that could affect the diagnosis of
             prostate cancer.

          -  History or current evidence of drug or alcohol abuse within the last 12 months.

          -  History of any illness (including psychiatric) that, in the opinion of the
             investigator, might confound the results of the study or pose additional risk to the
             subject.

          -  Known hypersensitivity to any 5α-reductase inhibitor or to any drug chemically related
             to dutasteride.