Prostate CancerPhase 3NCT00780754
Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia
A Phase 3 study testing dutasteride and prostate biopsy in people with Prostate Cancer, run by Kaunas University of Medicine at 1 site in Lithuania.
Trial summary
Patients with diagnosis of HPIN were enrolled. Patients were randomized into two groups: dutasteride treatment group and watchful waiting strategy group. According to the study protocol the subjects would undergo 10 core biopsies after 6, 12, 24, and 36 months after randomization. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- dutasteride and prostate biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteLithuania
- Study dates
- Apr 2007to Dec 2010
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age - 40-80 years
- HPIN on prostate biopsy specimens
- PSA below 20ng/ml
- No hormone therapy or radiation in pelvic region
- No previous treatment with 5alfa reductase inhibitors
- Signed Subject Information and Informed Subject Consent Form.
Who cannot join
- 1. Not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate
Patients with diagnosis of HPIN were enrolled. Patients were randomized into two groups: dutasteride treatment group and watchful waiting strategy group. According to the study protocol the subjects would undergo 10 core biopsies after 6, 12, 24, and 36 months after randomization.
There are assessed the rate of prostate cancer at repeated transrectal ultrasound guided biopsies and the effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).
- Conditions
- Prostate Cancer
- Being tested
- dutasteride, prostate biopsy
- Keywords
- prostate cancer, chemoprevention, dutasteride
- 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
0.5mg
prostate biopsyProcedure or surgery
prostate biopsy
| Study group | Role | What they receive |
|---|---|---|
| dutasteride | Experimental | treatment group Receives: Drug: dutasteride; Procedure: prostate biopsy |
| watchful waiting strategy | Active comparator | Not described Receives: Procedure: prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN
Measured: 6, 12, 24, and 36 months
Secondary outcomes (1)
effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).
Measured: 6, 12, 24, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startApr 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaunas University of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stasys Auskalnis, Lithuanian University of Health Sciences
- Investigators
- Daimantas Milonas, assist professor, Principal investigator, Kaunas Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780754
- Sponsor's protocol ID
- BE-2-27
- Status last verified
- Oct 2008
- First submitted
- 26 Oct 2008
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate
- ClinicalTrials.gov ID
- NCT00780754
- Acronym / sponsor ID
- BE-2-27
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, chemoprevention, dutasteride
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kaunas University of MedicineUniversity, hospital or other
- Study start
- Apr 2007 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Oct 2008 (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.
Patients with diagnosis of HPIN were enrolled. Patients were randomized into two groups: dutasteride treatment group and watchful waiting strategy group. According to the study protocol the subjects would undergo 10 core biopsies after 6, 12, 24, and 36 months after randomization.
There are assessed the rate of prostate cancer at repeated transrectal ultrasound guided biopsies and the effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dutasteride | Experimental | Drug: dutasteride, Procedure: prostate biopsytreatment group |
| watchful waiting strategy | Active comparator | Procedure: prostate biopsy |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age - 40-80 years
- HPIN on prostate biopsy specimens
- PSA below 20ng/ml
- No hormone therapy or radiation in pelvic region
- No previous treatment with 5alfa reductase inhibitors
Key exclusion criteria (1 listed)
- 1. Not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
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 |
|---|---|---|
| dutasteride0.5mg | Drug | dutasteride |
| prostate biopsyprostate biopsy | Procedure or surgery | dutasteride, watchful waiting strategy |
Primary outcome
rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN
Time frame: 6, 12, 24, and 36 months
1 secondary outcome
effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).
Time frame: 6, 12, 24, and 36 months
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 6 Mar 2018.
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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.
Daimantas Milonas, assist professor principal investigator
Kaunas Medical 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 and prostate biopsy in people with Prostate Cancer, run by Kaunas University of Medicine at 1 site in Lithuania.
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 6 inclusion and 1 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 6 Mar 2018. 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 Lithuania. 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.
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?
rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN (time frame: 6, 12, 24, and 36 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 6 Mar 2018.