Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk Prostate Cancer

Summary: RATIONALE: Diagnostic procedures, such as MRI and magnetic resonance spectroscopy imaging, may help in learning how well dutasteride works in patients with benign prostatic hypertrophy and low-risk prostate cancer.
  PURPOSE: This clinical trial is studying MRI and magnetic resonance spectroscopy imaging in patients receiving dutasteride for benign prostatic hypertrophy and low-risk prostate cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To determine whether there is a decrease in the extent of prostate cancer as measured by endorectal MRI and magnetic resonance spectroscopy imaging in patients with symptomatic benign prostatic hypertrophy and low-risk prostate cancer treated with dutasteride for 6 months.
  Secondary
  -  To monitor the effects of dutasteride on serum testosterone, dihydrotestosterone, and free and total prostate-specific antigen (PSA).
  -  To monitor the effects of dutasteride on symptom and quality-of-life indices.
  OUTLINE: Patients receive oral dutasteride once daily for 6 months.
  Patients undergo endorectal MRI and magnetic resonance spectroscopy imaging at baseline and at 1, 3, and 6 months.
  Patients complete quality-of-life questionnaires using the International Index of Erectile Function Questionnaire, American Urological Association Symptom Index, Functional Alterations due to Changes in Elimination, and Spitzer Quality-of-Life Index at baseline and at 1, 3, and 6 months.

Eligibility: Inclusion criteria:
  -  Histologically confirmed adenocarcinoma of the prostate
  -  Clinical stage T1b, T1c, or T2a disease
  -  Gleason score ≤ 6
  -  Maximal prostate-specific antigen (PSA) < 10 ng/mL
  -  Demonstrates intra-prostatic metabolite abnormalities, consistent with adenocarcinoma of the prostate (i.e., ≥ 3 voxels with magnetic resonance spectroscopy imaging [MRSI] scores 4-5) by baseline MRI and MRSI
  -  Has symptomatic benign prostatic hypertrophy and is currently undergoing watchful waiting OR opting to undergo permanent seed implant (i.e., brachytherapy), but requires neoadjuvant androgen suppression for prostate shrinkage
  -  No regional lymph node involvement
  -  No evidence of distant metastases
  -  Zubrod performance status 0-1
  -  Able to swallow and retain oral medications
  Exclusion Criteria:
  -  Other prior or concurrent invasive cancer, other than localized basal cell or squamous cell carcinoma of the skin
  -  Contraindications to MRI/MRSI, including any of the following:
  -  Prostate biopsy (within the past 8 weeks) and any continued post-biopsy bleeding
  -  Rectal bleeding
  -  Anal fissures
  -  Rectal surgery (end-to-end anastomosis)
  -  Inflammatory bowel disease
  -  Prior radical prostatectomy
  -  Hip replacement
  -  Certain types of penile implants
  -  Vascular clips
  -  Known anaphylactic reaction to latex compounds
  -  Anticoagulant drugs
  -  Severe claustrophobia
  -  Cardiac pacemaker
  -  Metal in eye
  -  Any other metallic or foreign object in the body
  -  Unstable serious co-morbidities including, but not limited to, myocardial infarction, coronary artery syndrome, cardiac arrhythmias, symptomatic congestive heart failure, or cerebrovascular accident
  -  Major medical or psychiatric illness that, in the investigator's opinion, would preclude the completion of treatment and interfere with follow up
  -  Known hypersensitivity to any 5α-reductase inhibitor or drug chemically related to the study drug
  -  Prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
  -  Prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  -  Prior or concurrent cytotoxic chemotherapy for prostate cancer
  -  Prior hormonal therapy, such as luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide acetate), antiandrogens (e.g., flutamide or bicalutamide), or estrogens (e.g., diethylstilbestrol)
  -  Prior or concurrent finasteride, dutasteride, other drugs with known antiandrogenic properties (e.g., spironolactone or progestational agents), or any dietary or herbal supplement (e.g., selenium, vitamin E, saw palmetto, or PC-SPES)

Relevance to patient case: not relevant