Benign Prostatic HypertrophyNCT00382356
Dutasteride After Failure of Finasteride In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)
A study testing Dutasteride in people with Benign Prostatic Hypertrophy, run by North Florida/South Georgia Veterans Health System.
Trial summary
The study is to determine the safety and efficacy of Dutasteride in patients who have failed Finasteride therapy for their symptomatic benign prostatic enlargement/ hypertrophy (BPE/H). Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hypertrophy
- What is being tested?
- Dutasteride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Jul 2009
- Phase
- Interventional
- 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 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male with history of treatment with Finasteride for more than six months, and who demonstrate clinical evidence of failure (subjective symptoms of bladder outlet obstruction secondary to BPH-related LUTS; objective evidence: AUASS> 10;Q-max > 5cc/sec and <10c/sec (total voided volume of at least 125cc); post void volumes > 200cc)
- Prostate volume > 30cc and < 80cc by transrectal ultrasound measurement
- Total Serum PSA of < 15 ng/ml (corrected for Finasteride therapy)
- Willingness and ability to give written informed consent and comply with study instructions and procedures.
Who cannot join
- Clinical evidence of non-response to therapy with Finasteride for symptomatic BPH.
- Total serum corrected PSA of greater than 15 ng/ml
- History or clinical evidence of prostate cancer
- History of acute urinary retention in three months prior.
About this study
Official title: A Pilot Investigation of Dutasteride (Avodart) After Failure of Finasteride (Proscar) In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)
The study is to determine the safety and efficacy of Dutasteride in patients who have failed Finasteride therapy for their symptomatic benign prostatic enlargement/ hypertrophy (BPE/H).
Read the detailed description
STUDY SUMMARY
TITLE: A Pilot Investigation of Dutasteride (Avodart) After Failure of Finasteride (Proscar) in the Management of Symptomatic Prostatic Enlargement/Hypertrophy OBJECTIVE: To determine the safety and efficacy of Dutasteride in patients who have failed Finasteride therapy for their symptomatic benign prostatic enlargement/ hypertrophy (BPE/H)
EXPERIMENTAL PLAN:
PATIENT SELECTION: Inclusion Criteria
- Patients who demonstrate clinical evidence of failure after treatment with Finasteride for 12 or more months. Failure includes one or more of the following: (i) AUA SS > 10; (ii) Q-max < 10 cc/sec; (iii) Post void residual volume (PVR) >200cc.
- Patients who remain subjectively symptomatic of LUTS secondary to BPH after treatment with Finasteride for at least six months.
Exclusion Criteria Patients with Neurogenic Bladder/LUTS secondary to neurologic disease Patients with the diagnosis of prostate cancer Patients with an allergy to Finasteride/Dutasteride
STUDY DESIGN AND DURATION:
This will be a single institution, open label pilot study involving 26 patients over 18-24 months. Each patient will be treated with the standard dose of Dutasteride for at least twelve months and followed for an additional 12 months.
EFFICACY AND SAFETY MEASUREMENTS:
Improvement in flowmetry, AUASS and PVR will be the primary outcome measures of efficacy. Quality of life measurement will be made also. The exploratory measures will include PSA and prostate volume. All adverse events including tolerability of the test agent will be recorded.
SUMMARY:
A positive result showing objective (AUASS, Q-max, PVR) and subjective (satisfaction index) improvement in these previously treated patients should engender interest in a multicenter study to confirm our data. The clinical import is that this population should be switched to Dutasteride without prolonged treatment with Finasteride for no additional benefit to the patient. A failure of treatment with one hormonal agent does not necessarily imply a lack of response to another agent of the same class.
- Conditions
- Benign Prostatic Hypertrophy
- Being tested
- Dutasteride
- Keywords
- Benign Prostatic Enlargement, Benign Prostatic Hypertrophy, Dutasteride, 5-alpha reductase inhibitors, Hormonal therapy
- Medical subject headings
- 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
once daily dosing of 0.5mg Dutasteride for 12 months
| Study group | Role | What they receive |
|---|---|---|
| study drug | Experimental | Open label, single arm Receives: Drug: Dutasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urodynamic parameters (Qmax, Voided volume, and PVR) and AUASS
Measured: 12 months
Secondary outcomes (1)
To assess safety and tolerability of Dutasteride
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startNov 2004
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HypertrophyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Florida/South Georgia Veterans Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Unyime O. Nseyo, MD, North Florida/South Georgia Veterans Health System
- Investigators
- Unyime O Nseyo, M.D., Principal investigator, NF/SGVAHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382356
- Sponsor's protocol ID
- AVODART-550-04
- Status last verified
- Oct 2012
- First submitted
- 28 Sep 2006
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Investigation of Dutasteride (Avodart) After Failure of Finasteride (Proscar) In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)
- ClinicalTrials.gov ID
- NCT00382356
- Acronym / sponsor ID
- AVODART-550-04
- Conditions
- Benign Prostatic Hypertrophy
- Keywords
- Benign Prostatic Enlargement, Benign Prostatic Hypertrophy, Dutasteride, 5-alpha reductase inhibitors, Hormonal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- North Florida/South Georgia Veterans Health SystemUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 29 Sep 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.
The study is to determine the safety and efficacy of Dutasteride in patients who have failed Finasteride therapy for their symptomatic benign prostatic enlargement/ hypertrophy (BPE/H).
Detailed description
STUDY SUMMARY
TITLE: A Pilot Investigation of Dutasteride (Avodart) After Failure of Finasteride (Proscar) in the Management of Symptomatic Prostatic Enlargement/Hypertrophy OBJECTIVE: To determine the safety and efficacy of Dutasteride in patients who have failed Finasteride therapy for their symptomatic benign prostatic enlargement/ hypertrophy (BPE/H)
EXPERIMENTAL PLAN:
PATIENT SELECTION: Inclusion Criteria
- Patients who demonstrate clinical evidence of failure after treatment with Finasteride for 12 or more months. Failure includes one or more of the following: (i) AUA SS > 10; (ii) Q-max < 10 cc/sec; (iii) Post void residual volume (PVR) >200cc.
- Patients who remain subjectively symptomatic of LUTS secondary to BPH after treatment with Finasteride for at least six months.
Exclusion Criteria Patients with Neurogenic Bladder/LUTS secondary to neurologic disease Patients with the diagnosis of prostate cancer Patients with an allergy to Finasteride/Dutasteride
STUDY DESIGN AND DURATION:
This will be a single institution, open label pilot study involving 26 patients over 18-24 months. Each patient will be treated with the standard dose of Dutasteride for at least twelve months and followed for an additional 12 months.
EFFICACY AND SAFETY MEASUREMENTS:
Improvement in flowmetry, AUASS and PVR will be the primary outcome measures of efficacy. Quality of life measurement will be made also. The exploratory measures will include PSA and prostate volume. All adverse events including tolerability of the test agent will be recorded.
SUMMARY:
A positive result showing objective (AUASS, Q-max, PVR) and subjective (satisfaction index) improvement in these previously treated patients should engender interest in a multicenter study to confirm our data. The clinical import is that this population should be switched to Dutasteride without prolonged treatment with Finasteride for no additional benefit to the patient. A failure of treatment with one hormonal agent does not necessarily imply a lack of response to another agent of the same class.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study drug | Experimental | Drug: DutasterideOpen label, single arm |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male with history of treatment with Finasteride for more than six months, and who demonstrate clinical evidence of failure (subjective symptoms of bladder outlet obstruction secondary to BPH-related LUTS; objective evidence: AUASS> 10;Q-max > 5cc/sec and <10c/sec (total voided volume of at least 125cc); post void volumes > 200cc)
- Prostate volume > 30cc and < 80cc by transrectal ultrasound measurement
- Total Serum PSA of < 15 ng/ml (corrected for Finasteride therapy)
- Willingness and ability to give written informed consent and comply with study instructions and procedures.
Key exclusion criteria (4 listed)
- Clinical evidence of non-response to therapy with Finasteride for symptomatic BPH.
- Total serum corrected PSA of greater than 15 ng/ml
- History or clinical evidence of prostate cancer
- History of acute urinary retention in three months prior.
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: Avodartonce daily dosing of 0.5mg Dutasteride for 12 months | Drug | study drug |
Primary outcome
Urodynamic parameters (Qmax, Voided volume, and PVR) and AUASS
Time frame: 12 months
1 secondary outcome
To assess safety and tolerability of Dutasteride
Time frame: 12 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 19 Oct 2012.
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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.
Unyime O Nseyo, M.D. principal investigator
NF/SGVAHS
Questions about this trial
What is this clinical trial studying?
A study testing Dutasteride in people with Benign Prostatic Hypertrophy, run by North Florida/South Georgia Veterans Health System.
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 4 inclusion and 4 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 19 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Urodynamic parameters (Qmax, Voided volume, and PVR) and AUASS (time frame: 12 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 19 Oct 2012.