TRADE-Testosterone Replacement and Dutasteride Effectiveness
Condition: Hypogonadism; Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hypogonadism; Hyperplasia
Intervention: Dutasteride; Testosterone gel; Placebo dutasteride
Intervention description: Dutasteride 0.5 mg orally daily; Testosterone gel 7.5 g daily topical; placebo dutasteride orally daily
Intervention MeSH terms: Testosterone; Dutasteride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 53.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: androgen deficiency; testosterone; Benign Prostatic Hyperplasia; hypogonadism; prostate; BPH

Summary:

      The purpose of this research study is to determine whether the combination of the male
      hormone testosterone [T] in gel form and the oral drug dutasteride [D], used to shrink large
      prostate glands can safely reduce the size of the prostate gland and symptoms of prostate
      enlargement (called benign prostatic hyperplasia [BPH]) compared to T treatment alone in men
      with low testosterone (called hypogonadism).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy older men 50 years old or older

          -  Hypogonadism; low testosterone (total T less than 280 ng/dL on one occasion or an
             average of equal to or less than 300 ng/dl on two occasions)

          -  Prostate volume equal to or more than 30 cc by prostate MRI

          -  Prostate Specific Antigen (PSA) equal to or more than 1.5 ng/mL and equal to or less
             than 10 ng/mL

          -  Subjects with a PSA greater than 4.0 ng/ml must have a negative prostate biopsy

          -  International Prostate Symptom Score (IPSS) greater than or equal to 8 and less than
             or equal to 20 at screening

          -  Comply with study procedures for the full 10 months

          -  No contraindications to MRI

        Subjects with symptomatic Benign Prostatic Hyperplasia (BPH) will be recruited from the
        Urology and General Internal Medicine Clinics at the VA Puget Sound Health Care System and
        University of Washington Medical Center in Seattle.

        Exclusion Criteria:

          -  A history of prostate or breast cancer

          -  Invasive therapy for BPH in the past

          -  History of acute urinary retention in the 3 months prior to screening

          -  Previous treatment with a 5 alpha-reductase inhibitor (finasteride or dutasteride)

          -  Medical therapy for BPH within the past month (alpha-blocker, phytotherapy)

          -  Use of androgenic or antiandrogenic drugs in the past year

          -  History or evidence of prostate cancer including suspicious DRE or history of
             high-grade PIN on prostate biopsy.

          -  Severe systemic illness (renal, liver, cardiac, lung disease, cancer, diabetes)

          -  Known untreated obstructive sleep apnea

          -  Hematocrit greater than 52

          -  Severe skin disease which may interfere with testosterone gel absorption

          -  Hypersensitivity to any of the drugs used in the study

          -  History of a bleeding disorder or need for chronic anticoagulation

          -  Participation in a drug study concurrently or in the last 90 days

          -  History or current evidence of drug or alcohol abuse within 12 mo.

          -  Weight more than 300 lbs.