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

NCT00706966 | Completed Results DMC

• 3 other identifiers: CDR0000596822UCSF-05551H7056-26910-03
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonmalignant Neoplasm; Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer; benign prostatic hyperplasia

Outcome Measures

Primary Outcomes (1)

• Change in Extent of Cancer

  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.

  1 month, 6 months

Secondary Outcomes (8)

• Adverse Events Indicative of Safety of Dutasteride

  Baseline, 1, 3, and 6 months

• Symptom Indices Over Time - IPSS

  Baseline, 1, 3, and 6 months

• Symptom Indices Over Time - IIEF-5

  Baseline, 1, 3, and 6 months

• Health-Related Quality of Life (HRQL) Indices Over Time - FACE

  Baseline, 1, 3, and 6 months

• Health-Related Quality of Life (HRQL) Indices Over Time - SQLI

  Baseline, 1, 3, and 6 months

Study Arms (1)

Dutasteride

EXPERIMENTAL

Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months

Drug: dutasteride

Interventions

dutasteride DRUG

6 months of dutasteride 3.5 mg daily

Also known as: Avodart

Dutasteride

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Neoplasms; Prostatic Neoplasms; Prostatic Hyperplasia

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The inclusion of only men with low volume disease may have limited our ability to accurately assess response rates after dutasteride due to the background effects on normal prostate metabolism.

Results Point of Contact

• Title: Mack Roach, MD
• Organization: University of California San Francisco

tdiep@radonc.ucsf.edu

415-353-9855

Study Officials

• Mack Roach, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: June 30, 2008
• Study Start: June 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: August 1, 2011
• Last Updated: January 17, 2014
• Results First Posted: January 17, 2014

Record last verified: 2013-12

Locations

US (1)