Prostate CancerPhase 3NCT00398281
Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer
A Phase 3 study testing dutasteride in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
RATIONALE: Diagnostic procedures, such as ultrasound-guided biopsy, may help find prostate cancer. Dutasteride may improve the ability of ultrasound-guided biopsy to find prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- dutasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Sep 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Suspected prostate cancer due to 1 of the following criteria:
- Prior abnormal digital rectal exam
- Elevated prostate-specific antigen (PSA) ≥ 2.6 ng/mL within the past 90 days
- PSA velocity > 0.75 ng/mL/year
- Must be planning to undergo a transrectal ultrasound with biopsy
PATIENT CHARACTERISTICS:
- Must be in adequate physical health to tolerate a prolonged transrectal examination and biopsy
- Must not be clinically unstable, severely ill, or moribund
PRIOR CONCURRENT THERAPY:
- More than 30 days since prior biopsy of the prostate
- More than 1 week since prior acetylsalicylic acid or blood thinner
- More than 30 days since prior participation in a clinical trial involving an investigational drug
- No prior therapy for prostate cancer
- No other concurrent 5-alpha reductase inhibitor
Trial locations and contacts
1 site in 1 country.
United States1 site
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
About this study
Official title: Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride
RATIONALE: Diagnostic procedures, such as ultrasound-guided biopsy, may help find prostate cancer. Dutasteride may improve the ability of ultrasound-guided biopsy to find prostate cancer. It is not yet known whether dutasteride followed by ultrasound-guided biopsy is more effective than a placebo followed by ultrasound-guided biopsy in finding prostate cancer.
PURPOSE: This randomized phase III trial is studying dutasteride and ultrasound-guided biopsy to see how well they find prostate cancer compared with a placebo and ultrasound-guided biopsy.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of dutasteride followed by contrast-enhanced, ultrasound-guided targeted biopsy in detecting prostate cancer.
- Determine the detection rate of prostate cancer with targeted biopsy using contrast-enhanced ultrasound combined with dutasteride.
- Determine the efficacy of targeted biopsy using contrast-enhanced ultrasound vs systematic biopsy in diagnosing clinically significant prostate cancer.
- Determine the reduction in post-biopsy bleeding after dutasteride in these patients.
- Determine the cost effectiveness of this regimen in these patients.
OUTLINE: This is a prospective, double-blind, placebo-controlled, randomized study. Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral dutasteride once daily on days 1-14.
- Arm II: Patients receive oral placebo once daily on days 1-14. On day 14, patients in both arms undergo blood collection and contrast-enhanced (perflutren protein-type A microspheres) transrectal ultrasound. Conventional gray-scale imaging, color Doppler imaging, and power Doppler imaging are performed. Biopsies are then performed; first up to 6 targeted ultrasound-guided biopsies and then up to 12 systematic biopsies.
After completion of study procedures, patients are followed at 1 day.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- dutasteride, placebo
- Keywords
- prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dutasterideDrug
Given orally
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral dutasteride once daily on days 1-14. Receives: Drug: dutasteride |
| Arm II | Placebo comparator | Patients receive oral placebo once daily on days 1-14. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of short-term dutasteride in improving prostate cancer detection
Detection rate of prostate cancer
Cost effectiveness of contrast-enhanced ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionJul 2010
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Ethan J. Halpern, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398281
- Sponsor's protocol ID
- CDR0000513051
- Other IDs
- TJUH-06F-145
- Status last verified
- Jun 2009
- First submitted
- 9 Nov 2006
- Last updated
- 10 Jan 2014
- Results posted
- No
Publications
Halpern EJ, Gomella LG, Forsberg F, McCue PA, Trabulsi EJ. Contrast enhanced transrectal ultrasound for the detection of prostate cancer: a randomized, double-blind trial of dutasteride pretreatment. J Urol. 2012 Nov;188(5):1739-45. doi: 10.1016/j.juro.2012.07.021. Epub 2012 Sep 19.
PubMed 22998915
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride
- ClinicalTrials.gov ID
- NCT00398281
- Acronym / sponsor ID
- CDR0000513051
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 10 Nov 2006 (estimated)
- Results
- Not posted in the source record
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 ultrasound-guided biopsy, may help find prostate cancer. Dutasteride may improve the ability of ultrasound-guided biopsy to find prostate cancer. It is not yet known whether dutasteride followed by ultrasound-guided biopsy is more effective than a placebo followed by ultrasound-guided biopsy in finding prostate cancer.
PURPOSE: This randomized phase III trial is studying dutasteride and ultrasound-guided biopsy to see how well they find prostate cancer compared with a placebo and ultrasound-guided biopsy.
Detailed description
OBJECTIVES:
- Determine the efficacy of dutasteride followed by contrast-enhanced, ultrasound-guided targeted biopsy in detecting prostate cancer.
- Determine the detection rate of prostate cancer with targeted biopsy using contrast-enhanced ultrasound combined with dutasteride.
- Determine the efficacy of targeted biopsy using contrast-enhanced ultrasound vs systematic biopsy in diagnosing clinically significant prostate cancer.
- Determine the reduction in post-biopsy bleeding after dutasteride in these patients.
- Determine the cost effectiveness of this regimen in these patients.
OUTLINE: This is a prospective, double-blind, placebo-controlled, randomized study. Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral dutasteride once daily on days 1-14.
- Arm II: Patients receive oral placebo once daily on days 1-14. On day 14, patients in both arms undergo blood collection and contrast-enhanced (perflutren protein-type A microspheres) transrectal ultrasound. Conventional gray-scale imaging, color Doppler imaging, and power Doppler imaging are performed. Biopsies are then performed; first up to 6 targeted ultrasound-guided biopsies and then up to 12 systematic biopsies.
After completion of study procedures, patients are followed at 1 day.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: dutasteridePatients receive oral dutasteride once daily on days 1-14. |
| Arm II | Placebo comparator | Other: placeboPatients receive oral placebo once daily on days 1-14. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| dutasterideGiven orally | Drug | Arm I |
| placeboGiven orally | Other | Arm II |
Primary outcome
Efficacy of short-term dutasteride in improving prostate cancer detection
Detection rate of prostate cancer
Cost effectiveness of contrast-enhanced ultrasound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
- Derived from this study: PubMed 22998915Halpern EJ, Gomella LG, Forsberg F, McCue PA, Trabulsi EJ. Contrast enhanced transrectal ultrasound for the detection of prostate cancer: a randomized, double-blind trial of dutasteride pretreatment. J Urol. 2012 Nov;188(5):1739-45. doi: 10.1016/j.juro.2012.07.021. Epub 2012 Sep 19.
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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.
Ethan J. Halpern, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dutasteride in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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?
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 10 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of short-term dutasteride in improving prostate cancer detection. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00398281, which also lists 1 linked publication.
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 10 Jan 2014.