A Pilot Study of MRI and Spectroscopy Imaging Changes With 6-months of Dutasteride in Patients With Symptomatic Benign Prostatic Hypertrophy and Low-risk Prostate Cancer on Watchful Waiting or Requiring Neoadjuvant Androgen Suppression Prior to Prostate Brachytherapy
Overview
- Phase
- Not Applicable
- Intervention
- dutasteride
- Conditions
- Nonmalignant Neoplasm
- Sponsor
- University of California, San Francisco
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change in Extent of Cancer
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Arms & Interventions
Dutasteride
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
Intervention: dutasteride
Outcomes
Primary Outcomes
Change in Extent of Cancer
Time Frame: 1 month, 6 months
Proportion of voxels consistent with prostate cancer as measured by magnetic resonance spectroscopy imaging (MRSI). MRSI spectra were examined and scored as healthy or cancerous. The change in cancerous volumes over time was evaluated. Because a significant decrease in citrate and polyamines on MRSI spectra was noted at 1 month compared with baseline, healthy tissue appeared to be more like cancer and thus created a false impression that the cancer had grown after 1 month. To reduce this bias, primary comparisons were made between the 1-month and 6-month scans.
Secondary Outcomes
- Symptom Indices Over Time - IIEF-5(Baseline, 1, 3, and 6 months)
- Health-Related Quality of Life (HRQL) Indices Over Time - SQLI(Baseline, 1, 3, and 6 months)
- Health-Related Quality of Life (HRQL) Indices Over Time - FACE(Baseline, 1, 3, and 6 months)
- Total PSA Over Time(Baseline, 1, 3, and 6 months)
- Symptom Indices Over Time - IPSS(Baseline, 1, 3, and 6 months)
- Adverse Events Indicative of Safety of Dutasteride(Baseline, 1, 3, and 6 months)
- Dihydrotestosterone (DHT) Over Time(Baseline, 1, 3, and 6 months)
- Testosterone Over Time(Baseline, 1, 3, and 6 months)