Trial Outcomes & Findings for MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk Prostate Cancer (NCT NCT00706966)
NCT ID: NCT00706966
Last Updated: 2014-01-17
Results Overview
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.
COMPLETED
NA
10 participants
1 month, 6 months
2014-01-17
Participant Flow
Patients were recruited from June 2005 to June 2008 from untreated patients seen at the University of California San Francisco
Participant milestones
| Measure |
Dutasteride
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride : 6 months of dutasteride 3.5 mg daily
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Dutasteride
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride : 6 months of dutasteride 3.5 mg daily
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk Prostate Cancer
Baseline characteristics by cohort
| Measure |
Dutasteride
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride : 6 months of dutasteride 3.5 mg daily
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
|
Clinical Stage
T1c
|
7 Participants
n=5 Participants
|
|
Clinical Stage
T2a
|
3 Participants
n=5 Participants
|
|
Total PSA
|
5.05 ng/mL
n=5 Participants
|
|
Prostate volume
|
47.3 mL
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month, 6 monthsPopulation: One participant withdrew from the study
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.
Outcome measures
| Measure |
Dutasteride
n=9 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride : 6 months of dutasteride 3.5 mg daily
|
Dutasteride - 1 Month
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 1 month.
|
Dutasteride - 3 Months
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 3 months.
|
Dutasteride - 6 Months
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 6 months.
|
|---|---|---|---|---|
|
Change in Extent of Cancer
30-45% Decrease
|
3 participants
|
—
|
—
|
—
|
|
Change in Extent of Cancer
No change (95 - 100%)
|
2 participants
|
—
|
—
|
—
|
|
Change in Extent of Cancer
65-167% Increase
|
4 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1, 3, and 6 monthsToxicities from Dutasteride were recorded at each study visit and assessed by NCI-CTCAE v3.0.
Outcome measures
| Measure |
Dutasteride
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride : 6 months of dutasteride 3.5 mg daily
|
Dutasteride - 1 Month
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 1 month.
|
Dutasteride - 3 Months
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 3 months.
|
Dutasteride - 6 Months
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 6 months.
|
|---|---|---|---|---|
|
Adverse Events Indicative of Safety of Dutasteride
|
5 adverse events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1, 3, and 6 monthsPopulation: Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.
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).
Outcome measures
| Measure |
Dutasteride
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride : 6 months of dutasteride 3.5 mg daily
|
Dutasteride - 1 Month
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 1 month.
|
Dutasteride - 3 Months
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 3 months.
|
Dutasteride - 6 Months
n=9 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 6 months.
|
|---|---|---|---|---|
|
Symptom Indices Over Time - IPSS
|
8.8 units on a scale
Standard Deviation 3.8
|
6.6 units on a scale
Standard Deviation 3.0
|
7.9 units on a scale
Standard Deviation 4.4
|
5.9 units on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline, 1, 3, and 6 monthsPopulation: One participant withdrew from the study prior to the 6 month timepoint; thus n=9 at 6 months.
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
Outcome measures
| Measure |
Dutasteride
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride : 6 months of dutasteride 3.5 mg daily
|
Dutasteride - 1 Month
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 1 month.
|
Dutasteride - 3 Months
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 3 months.
|
Dutasteride - 6 Months
n=9 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 6 months.
|
|---|---|---|---|---|
|
Symptom Indices Over Time - IIEF-5
|
16.4 units on a scale
Standard Deviation 7.8
|
17.0 units on a scale
Standard Deviation 8.7
|
16.0 units on a scale
Standard Deviation 7.9
|
15.3 units on a scale
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Baseline, 1, 3, and 6 monthsPopulation: One participant withdrew from the study prior to the 6 month timepoint; thus n=9 at 6 months.
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.
Outcome measures
| Measure |
Dutasteride
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride : 6 months of dutasteride 3.5 mg daily
|
Dutasteride - 1 Month
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 1 month.
|
Dutasteride - 3 Months
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 3 months.
|
Dutasteride - 6 Months
n=9 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 6 months.
|
|---|---|---|---|---|
|
Health-Related Quality of Life (HRQL) Indices Over Time - FACE
|
4.6 units on a scale
Standard Deviation 2.5
|
4.7 units on a scale
Standard Deviation 1.2
|
5.0 units on a scale
Standard Deviation 1.9
|
4.8 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline, 1, 3, and 6 monthsPopulation: One participant withdrew from the study prior to 6 months; thus, n=9 at 6 months.
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.
Outcome measures
| Measure |
Dutasteride
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride : 6 months of dutasteride 3.5 mg daily
|
Dutasteride - 1 Month
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 1 month.
|
Dutasteride - 3 Months
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 3 months.
|
Dutasteride - 6 Months
n=9 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 6 months.
|
|---|---|---|---|---|
|
Health-Related Quality of Life (HRQL) Indices Over Time - SQLI
|
9.7 units on a scale
Standard Deviation 0.7
|
9.9 units on a scale
Standard Deviation 0.3
|
9.6 units on a scale
Standard Deviation 0.7
|
9.9 units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Baseline, 1, 3, and 6 monthsPopulation: Because one participant withdrew from the study prior to 6-months, n=9 for the 6-month Mean(SD) levels.
Outcome measures
| Measure |
Dutasteride
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride : 6 months of dutasteride 3.5 mg daily
|
Dutasteride - 1 Month
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 1 month.
|
Dutasteride - 3 Months
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 3 months.
|
Dutasteride - 6 Months
n=9 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 6 months.
|
|---|---|---|---|---|
|
Total PSA Over Time
|
5.44 ng/mL
Standard Deviation 2.90
|
4.33 ng/mL
Standard Deviation 2.23
|
2.85 ng/mL
Standard Deviation 1.49
|
2.59 ng/mL
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: Baseline, 1, 3, and 6 monthsPopulation: Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.
Outcome measures
| Measure |
Dutasteride
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride : 6 months of dutasteride 3.5 mg daily
|
Dutasteride - 1 Month
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 1 month.
|
Dutasteride - 3 Months
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 3 months.
|
Dutasteride - 6 Months
n=9 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 6 months.
|
|---|---|---|---|---|
|
Dihydrotestosterone (DHT) Over Time
|
33.5 ng/dL
Standard Deviation 8.9
|
5.2 ng/dL
Standard Deviation 5.5
|
2.5 ng/dL
Standard Deviation 0.8
|
2.5 ng/dL
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline, 1, 3, and 6 monthsPopulation: Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.
Outcome measures
| Measure |
Dutasteride
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride : 6 months of dutasteride 3.5 mg daily
|
Dutasteride - 1 Month
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 1 month.
|
Dutasteride - 3 Months
n=10 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 3 months.
|
Dutasteride - 6 Months
n=9 Participants
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 6 months.
|
|---|---|---|---|---|
|
Testosterone Over Time
|
356.5 ng/dL
Standard Deviation 109.3
|
418.4 ng/dL
Standard Deviation 155.7
|
443.2 ng/dL
Standard Deviation 132.1
|
484.3 ng/dL
Standard Deviation 106.0
|
Adverse Events
Dutasteride
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dutasteride
n=10 participants at risk
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride: 6 months of dutasteride 3.5 mg daily
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 2 • 6 months
Toxicities from dutasteride were recorded at each follow-up visit using the National Cancer Institute's Common Terminology Criteria for Adverse Events toxicity scale version 3.0
|
|
Reproductive system and breast disorders
Decreased ejaculate volume
|
30.0%
3/10 • Number of events 3 • 6 months
Toxicities from dutasteride were recorded at each follow-up visit using the National Cancer Institute's Common Terminology Criteria for Adverse Events toxicity scale version 3.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place