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

Primary Purpose

Nonmalignant Neoplasm, Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dutasteride
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nonmalignant Neoplasm focused on measuring adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, benign prostatic hyperplasia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dutasteride

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse Events Indicative of Safety of Dutasteride
Toxicities from Dutasteride were recorded at each study visit and assessed by NCI-CTCAE v3.0.
Symptom Indices Over Time - IPSS
IPSS (The International Prostate Symptom Score) is a symptom index based on seven questions concerning urinary symptoms (1 Incomplete emptying, 2 Frequency, 3 Intermittency, 4 Urgency, 5 Weak Stream, 6 Straining, 7 Nocturia) for which the patient chooses one out of six answers indicating increasing severity of the particular symptom, ranging from 0 (Not at all) to 5(Almost always). The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); Severe (symptom score range 20-35).
Symptom Indices Over Time - IIEF-5
The International Index of Erectile Function (IIEF-5) is an abridged five-item version of the original IIEF 15-item questionnaire designed to evaluate erectile function, based on a definition arrived at by the National Institutes of Health Consensus Panel. Each of 5 questions about erectile function over the past 6 months is scored by the patient from 1 (severe dysfunction) to 5 (little or no dysfunction). The IIEF-5 is scored from 5 to 25, with lower scores indicating erectile dysfunction: 22-25 = No erectile dysfunction; 17-21 = Mild erectile dysfunction; 12-16 = Mild to moderate erectile dysfunction; 8-11 = Moderate erectile dysfunction; 5-7 = Severe erectile dysfunction
Health-Related Quality of Life (HRQL) Indices Over Time - FACE
Functional Alterations due to Changes in Elimination (FACE) is a 14-item questionnaire designed to evaluate the effects of changes in urinary and bowel elimination on daily functioning. It is scored out of 56, with higher scores reflecting poorer HRQL.
Health-Related Quality of Life (HRQL) Indices Over Time - SQLI
The Spitzer Quality of Life Index (SQLI) is a validated five-item questionnaire evaluating global HRQL. Activity, daily living, health, support of family and friends, and outlook are each rated on a 3-point scale (0 to 2), with total score ranging from 0-10, with lower score indicating poorer HRQL.
Total PSA Over Time
Dihydrotestosterone (DHT) Over Time
Testosterone Over Time

Full Information

First Posted
June 27, 2008
Last Updated
December 2, 2013
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00706966
Brief Title
MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk Prostate Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonmalignant Neoplasm, Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, benign prostatic hyperplasia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dutasteride
Arm Type
Experimental
Arm Description
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
Intervention Type
Drug
Intervention Name(s)
dutasteride
Other Intervention Name(s)
Avodart
Intervention Description
6 months of dutasteride 3.5 mg daily
Primary Outcome Measure Information:
Title
Change in Extent of Cancer
Description
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.
Time Frame
1 month, 6 months
Secondary Outcome Measure Information:
Title
Adverse Events Indicative of Safety of Dutasteride
Description
Toxicities from Dutasteride were recorded at each study visit and assessed by NCI-CTCAE v3.0.
Time Frame
Baseline, 1, 3, and 6 months
Title
Symptom Indices Over Time - IPSS
Description
IPSS (The International Prostate Symptom Score) is a symptom index based on seven questions concerning urinary symptoms (1 Incomplete emptying, 2 Frequency, 3 Intermittency, 4 Urgency, 5 Weak Stream, 6 Straining, 7 Nocturia) for which the patient chooses one out of six answers indicating increasing severity of the particular symptom, ranging from 0 (Not at all) to 5(Almost always). The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); Severe (symptom score range 20-35).
Time Frame
Baseline, 1, 3, and 6 months
Title
Symptom Indices Over Time - IIEF-5
Description
The International Index of Erectile Function (IIEF-5) is an abridged five-item version of the original IIEF 15-item questionnaire designed to evaluate erectile function, based on a definition arrived at by the National Institutes of Health Consensus Panel. Each of 5 questions about erectile function over the past 6 months is scored by the patient from 1 (severe dysfunction) to 5 (little or no dysfunction). The IIEF-5 is scored from 5 to 25, with lower scores indicating erectile dysfunction: 22-25 = No erectile dysfunction; 17-21 = Mild erectile dysfunction; 12-16 = Mild to moderate erectile dysfunction; 8-11 = Moderate erectile dysfunction; 5-7 = Severe erectile dysfunction
Time Frame
Baseline, 1, 3, and 6 months
Title
Health-Related Quality of Life (HRQL) Indices Over Time - FACE
Description
Functional Alterations due to Changes in Elimination (FACE) is a 14-item questionnaire designed to evaluate the effects of changes in urinary and bowel elimination on daily functioning. It is scored out of 56, with higher scores reflecting poorer HRQL.
Time Frame
Baseline, 1, 3, and 6 months
Title
Health-Related Quality of Life (HRQL) Indices Over Time - SQLI
Description
The Spitzer Quality of Life Index (SQLI) is a validated five-item questionnaire evaluating global HRQL. Activity, daily living, health, support of family and friends, and outlook are each rated on a 3-point scale (0 to 2), with total score ranging from 0-10, with lower score indicating poorer HRQL.
Time Frame
Baseline, 1, 3, and 6 months
Title
Total PSA Over Time
Time Frame
Baseline, 1, 3, and 6 months
Title
Dihydrotestosterone (DHT) Over Time
Time Frame
Baseline, 1, 3, and 6 months
Title
Testosterone Over Time
Time Frame
Baseline, 1, 3, and 6 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mack Roach, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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