Benign Prostatic HyperplasiaPhase 3NCT00564460
On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)
A Phase 3 study testing Finasteride in people with Benign Prostatic Hyperplasia, run by University of Alberta at 1 site in Canada.
Trial summary
Transurethral resection of the prostate (TURP) is a common treatment for benign prostatic hyperplasia (BPH). A common complication of TURP is blood loss. Preliminary data suggest that preoperative Finasteride, a 5 alpha-reductase inhibitor, may reduce blood loss during TURP. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Finasteride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to Feb 2011
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TRUS-confirmed prostate gland > 30 g,
- 18 years of age or older,
- fit and scheduled to receive TURP,
- approval of the treating urologist,
- able to understand and provide written informed consent in English
Who cannot join
- active psychiatric condition,
- previous Finasteride use,
- abnormal DRE,
- PSA greater than 4.0 ng/ml,
- current anticoagulation use (Heparin, Warfarin),
- ESRD,
- previous prostate or urethral surgery,
- deemed to be a candidate for immediate surgery (within 1 week of initial evaluation).
Trial locations and contacts
1 site in 1 country.
About this study
Transurethral resection of the prostate (TURP) is a common treatment for benign prostatic hyperplasia (BPH). A common complication of TURP is blood loss. Preliminary data suggest that preoperative Finasteride, a 5 alpha-reductase inhibitor, may reduce blood loss during TURP. However, no study has examined the effect of preoperative Finasteride on clinical outcomes.
The study is a randomized, double-blind, placebo-controlled trial of preoperative Finasteride versus placebo in BPH patients undergoing TURP. Participants will be stratified by prostate volume (30 to 65 grams versus 66 to 100 grams) and randomly assigned to preoperative Finasteride or placebo. The primary end point is incidence of RBCT. Secondary end points are standard units of red blood cells transfused, variables related to perioperative bleeding (incidence of readmission, incidence of return to hospital, length of hospital stay), blood loss, change in serum hemoglobin, change in serum hematocrit, blood loss per gram of resected prostate tissue, operating time, change in AUA-SS, and change in HRQOL.
Read the detailed description
The proposed trial is warranted for two main reasons. First, no study has examined the effect of preoperative Finasteride on important clinical outcomes such as the incidence of red blood cell transfusion, standard units of red blood cells transfused, readmission, return to hospital, and length of hospital stay. Second, a definitive randomized, double-blind, placebo-controlled trial documenting the efficacy of preoperative Finasteride on blood loss variables (e.g., intra-operative blood loss, change in serum hemoglobin) has yet to be conducted.
Participants will be recruited from the practices of Credentialed Urologists at the Alberta Urology Institute (AUI) and UAH in Edmonton, Alberta, Canada. The eligibility criteria include medical, demographic, and logistic criterion, and focus on internal validity as well as external validity. Eligibility criteria for the study are: (1) TRUS-confirmed prostate gland > 30 g, (2) 18 years of age or older, (3) fit and scheduled to receive TURP, (4) approval of the treating urologist, (5) able to understand and provide written informed consent in English, (6) no active psychiatric condition, (7) no previous Finasteride use, (8) normal DRE, (9) PSA greater than or equal to 4.0 ng/ml, (10) no current anticoagulation use (Heparin, Warfarin), (11) no ESRD, (12) no previous prostate or urethral surgery, and (13) not deemed to be a candidate for immediate surgery (within 1 week of initial evaluation).
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Finasteride, Placebo
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinasterideDrug
Also called Proscar
Finasteride 5 mg PO once daily for 8 weeks prior to TURP
PlaceboDrug
Placebo once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Finasteride 5 mg PO once daily for 8 weeks prior to TURP Receives: Drug: Finasteride |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the incidence of red blood cell transfusion after TURP in BPH patients randomized to receive preoperative Finasteride with those randomized to receive placebo.
Measured: During/post surgery
Secondary outcomes (1)
To compare standard units of red blood cells transfused, variables related to perioperative bleeding, blood loss, serum hemoglobin, serum hematocrit, blood loss per gram of resected prostate tissue, operating time, AUA-SS, HRQOL after TURP
Measured: during/post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2007 (estimated)
- Study startFeb 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Change of practice pattern. Green light laser
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Frosst Canada Ltd.
- Responsible party
- Sponsor
- Investigators
- Howard Evans, MD, Principal investigator, AUIRC/University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564460
- Sponsor's protocol ID
- E-2007
- Status last verified
- Nov 2009
- First submitted
- 26 Nov 2007
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)
- ClinicalTrials.gov ID
- NCT00564460
- Acronym / sponsor ID
- E-2007
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change of practice pattern. Green light laser
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Merck Frosst Canada Ltd.
- Study start
- Feb 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 28 Nov 2007 (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.
Transurethral resection of the prostate (TURP) is a common treatment for benign prostatic hyperplasia (BPH). A common complication of TURP is blood loss. Preliminary data suggest that preoperative Finasteride, a 5 alpha-reductase inhibitor, may reduce blood loss during TURP. However, no study has examined the effect of preoperative Finasteride on clinical outcomes.
The study is a randomized, double-blind, placebo-controlled trial of preoperative Finasteride versus placebo in BPH patients undergoing TURP. Participants will be stratified by prostate volume (30 to 65 grams versus 66 to 100 grams) and randomly assigned to preoperative Finasteride or placebo. The primary end point is incidence of RBCT. Secondary end points are standard units of red blood cells transfused, variables related to perioperative bleeding (incidence of readmission, incidence of return to hospital, length of hospital stay), blood loss, change in serum hemoglobin, change in serum hematocrit, blood loss per gram of resected prostate tissue, operating time, change in AUA-SS, and change in HRQOL.
Detailed description
The proposed trial is warranted for two main reasons. First, no study has examined the effect of preoperative Finasteride on important clinical outcomes such as the incidence of red blood cell transfusion, standard units of red blood cells transfused, readmission, return to hospital, and length of hospital stay. Second, a definitive randomized, double-blind, placebo-controlled trial documenting the efficacy of preoperative Finasteride on blood loss variables (e.g., intra-operative blood loss, change in serum hemoglobin) has yet to be conducted.
Participants will be recruited from the practices of Credentialed Urologists at the Alberta Urology Institute (AUI) and UAH in Edmonton, Alberta, Canada. The eligibility criteria include medical, demographic, and logistic criterion, and focus on internal validity as well as external validity. Eligibility criteria for the study are: (1) TRUS-confirmed prostate gland > 30 g, (2) 18 years of age or older, (3) fit and scheduled to receive TURP, (4) approval of the treating urologist, (5) able to understand and provide written informed consent in English, (6) no active psychiatric condition, (7) no previous Finasteride use, (8) normal DRE, (9) PSA greater than or equal to 4.0 ng/ml, (10) no current anticoagulation use (Heparin, Warfarin), (11) no ESRD, (12) no previous prostate or urethral surgery, and (13) not deemed to be a candidate for immediate surgery (within 1 week of initial evaluation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: FinasterideFinasteride 5 mg PO once daily for 8 weeks prior to TURP |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- TRUS-confirmed prostate gland > 30 g,
- 18 years of age or older,
- fit and scheduled to receive TURP,
- approval of the treating urologist,
- able to understand and provide written informed consent in English
Key exclusion criteria (8 listed)
- active psychiatric condition,
- previous Finasteride use,
- abnormal DRE,
- PSA greater than 4.0 ng/ml,
- current anticoagulation use (Heparin, Warfarin),
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 |
|---|---|---|
| FinasterideAlso: ProscarFinasteride 5 mg PO once daily for 8 weeks prior to TURP | Drug | 1 |
| PlaceboPlacebo once daily for 8 weeks | Drug | 2 |
Primary outcome
To compare the incidence of red blood cell transfusion after TURP in BPH patients randomized to receive preoperative Finasteride with those randomized to receive placebo.
Time frame: During/post surgery
1 secondary outcome
To compare standard units of red blood cells transfused, variables related to perioperative bleeding, blood loss, serum hemoglobin, serum hematocrit, blood loss per gram of resected prostate tissue, operating time, AUA-SS, HRQOL after TURP
Time frame: during/post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
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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.
Howard Evans, MD principal investigator
AUIRC/University of Alberta
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 Finasteride in people with Benign Prostatic Hyperplasia, run by University of Alberta at 1 site in Canada.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 30 Oct 2017. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
To compare the incidence of red blood cell transfusion after TURP in BPH patients randomized to receive preoperative Finasteride with those randomized to receive placebo. (time frame: During/post surgery). 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 30 Oct 2017.