Nonmalignant NeoplasmNCT00706966
MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk Prostate Cancer
A study testing dutasteride in people with Nonmalignant Neoplasm and Prostate Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Nonmalignant Neoplasm, Prostate Cancer
- What is being tested?
- dutasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- No regional lymph node involvement
- No evidence of distant metastases
- Zubrod performance status 0-1
- Able to swallow and retain oral medications
Who cannot join
- 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)
Show all 25Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
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
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.
Read the 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.
- Conditions
- Nonmalignant Neoplasm, Prostate Cancer
- Being tested
- dutasteride
- Keywords
- adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, benign prostatic hyperplasia
- Medical subject headings
- Neoplasms, Prostatic Neoplasms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dutasterideDrug
Also called Avodart
6 months of dutasteride 3.5 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Dutasteride | Experimental | Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months Receives: Drug: dutasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month, 6 months
Secondary outcomes (8)
Adverse Events Indicative of Safety of Dutasteride
Toxicities from Dutasteride were recorded at each study visit and assessed by NCI-CTCAE v3.0.
Measured: Baseline, 1, 3, and 6 months
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).
Measured: Baseline, 1, 3, and 6 months
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
Measured: Baseline, 1, 3, and 6 months
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.
Measured: Baseline, 1, 3, and 6 months
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.
Measured: Baseline, 1, 3, and 6 months
Total PSA Over Time
Measured: Baseline, 1, 3, and 6 months
Dihydrotestosterone (DHT) Over Time
Measured: Baseline, 1, 3, and 6 months
Testosterone Over Time
Measured: Baseline, 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startJun 2005
- Primary completionDec 2008
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nonmalignant NeoplasmStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mack Roach, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706966
- Sponsor's protocol ID
- CDR0000596822
- Other IDs
- UCSF-05551, H7056-26910-03
- Status last verified
- Dec 2013
- First submitted
- 27 Jun 2008
- Last updated
- 17 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00706966
- Acronym / sponsor ID
- CDR0000596822
- Conditions
- Nonmalignant Neoplasm, Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, benign prostatic hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 30 Jun 2008 (estimated)
- Results
- Posted 17 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dutasteride | Experimental | Drug: dutasterideDutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed adenocarcinoma of the prostate
- 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
Key exclusion criteria (25 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dutasterideAlso: Avodart6 months of dutasteride 3.5 mg daily | Drug | Dutasteride |
Primary outcome
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.
8 secondary outcomes
Adverse Events Indicative of Safety of Dutasteride
Time frame: Baseline, 1, 3, and 6 months
Symptom Indices Over Time - IPSS
Time frame: Baseline, 1, 3, and 6 months
Symptom Indices Over Time - IIEF-5
Time frame: Baseline, 1, 3, and 6 months
Health-Related Quality of Life (HRQL) Indices Over Time - FACE
Time frame: Baseline, 1, 3, and 6 months
Health-Related Quality of Life (HRQL) Indices Over Time - SQLI
Time frame: Baseline, 1, 3, and 6 months
Total PSA Over Time
Time frame: Baseline, 1, 3, and 6 months
Dihydrotestosterone (DHT) Over Time
Time frame: Baseline, 1, 3, and 6 months
Testosterone Over Time
Time frame: Baseline, 1, 3, and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mack Roach, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dutasteride in people with Nonmalignant Neoplasm and Prostate Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Extent of Cancer (time frame: 1 month, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2014.