Benign Prostate HyperplasiaPhase 4NCT02006303
Prostatic Artery Embolization Versus 532 nm Green Light PVP for Catheterized Patients
A Phase 4 study testing Green light PVP and Prostatic artery embolization in people with Benign Prostate Hyperplasia and Urinary Retention, run by Royal Victoria Hospital, Canada at 2 sites in Canada.
Trial summary
The primary objective is to assess whether prostatic artery embolization has a similar efficacy and safety profile as GreenLight PVP in treating patients with urinary retention secondary to benign prostate hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 40 to 95 years, men only
- Conditions the study is for
- Benign Prostate Hyperplasia, Urinary Retention
- What is being tested?
- Green light PVP and Prostatic artery embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2013to Dec 2015
- Phase
- Phase 4
- 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 95 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subjects, over 50 years of age at the time of enrollment.
- Subjects referred to urology for BPH leading to permanent indwelling bladder catheters and are considered poor surgical candidates
- Written informed consent to participate in the study.
- Ability to comply with the requirements of the study procedures
Who cannot join
- Previous surgical treatment for BPH
- Presence of bladder stones
- History of prostate cancer
- Prostate size > 150 g
- History of urethral stenosis or its management
- Known of suspected neurogenic bladder
Show all 13Show fewer
- History of recent hematochezia in the last 3 months
- Contraindication to intravascular iodinated contrast such as allergies or significant elevated creatinine/renal failure
- Uncorrected coagulopathy
- Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
- Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
- Subjects who are uncooperative or cannot follow instructions.
- Mental state that may preclude completion of the study procedure or obtention of informed consent
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Mostafa Elhilali, MD,PhD,FRCSC, 1- 514- 843-1516, mostafa.elhilali@muhc.mcgill.ca
Mohamed Elkoushy, MD. MSc, PhD, 1-514- 318- 6777, melkoushy@yahoo.com
- Recruiting
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Carlos Torres, MD,FRCPC, 1-514- 934-1934x44454, citorresp@yahoo.com
Louis-Martin Boucher, MD, PhD, 1- 514- 934-8003, lmboucher@yahoo.com
About this study
Official title: Prostatic Artery Embolization Versus 532 nm Green Light Laser Photoselective Vaporization of the Prostate for Treating Catheter-Dependent Patients With Benign Prostatic Hyperplasia: A Randomized Controlled Clinical Study
The primary objective is to assess whether prostatic artery embolization has a similar efficacy and safety profile as GreenLight PVP in treating patients with urinary retention secondary to benign prostate hyperplasia (BPH). Subjects who consent will be randomized to either the Prostate embolization (PAE) arm or to the GreenLight PVP arm.
The primary endpoint of efficacy of the procedure is measured by the ability of the patient to void. The secondary endpoints recorded will include patients' satisfaction measured by International Prostate Symptom Score (IPSS), peak flow rate (Qmax) and post-void residual urine volume (PVR) and prostate specific antigen (PSA) will be measured at 3, 6, and 12 months post treatment. Also, reduction in prostate volume is considered by MRI preoperatively, 3 months and 12 months.
Read the detailed description
The primary objective is to assess whether prostatic artery embolization has a similar efficacy and safety profile compared to GreenLight PVP in treating patients with urinary retention secondary to benign prostate hyperplasia (BPH) that have failed medical management.
The target population is composed of subjects referred to the urology department for treatment of BPH who have failed medical treatment, who present with permanent bladder catheterization and who meet the eligibility criteria.
Subjects who consent will be randomized to either the Prostate embolization (PAE) arm or to the GreenLight PVP arm.
The primary endpoint of efficacy of the procedure is measured by the successful removal of bladder catheter and ability of the patient to void. As well, the secondary endpoints recorded will be: International Prostate Symptom Score (IPSS), peak flow rate (Qmax) and post-void residual urine volume (PVP) and prostate specific antigen (PSA) will be measured at 3, 6, and 12 months post treatment. Trans-rectal ultrasound (TRUS) will be performed for measurement of prostate volume for the stratified randomization process. All adverse events will be captured and analyzed. MRI will be performed preoperatively, 3 months and 12 months. Hospital stays after the procedures will not be considered serious adverse events, unless a hospital admission occurs because of a complication of the treatment performed.
- Conditions
- Benign Prostate Hyperplasia, Urinary Retention
- Being tested
- Green light PVP, Prostatic artery embolization
- Keywords
- Benign Prostate Hyperplasia, Green light, Photoselective vaporization of the prostate, Prostatic artery embolization, Outcome
- Medical subject headings
- Prostatic Hyperplasia, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green light PVPProcedure or surgery
Also called XPS (Xcelerated Performance System), PVP, Photoselective vaporization of the prostate
The green light laser has a wavelength of 532 nm which is strongly absorbed by red tissues and hemoglobin; this renders a blood rich organ such as the prostate gland to be an excellent target. The procedure uses the technology of high-powered laser light combined with fiber optics to vaporize the overgrowth of prostate cells quickly and accurately. As the surgeon directs the laser at the prostate, the intense pulses of light emitted from the fiber are absorbed by the blood. Within moments, the temperature of the blood becomes so great it causes the nearby cells to vaporize. Once the procedure is completed, patients have immediate post-operative symptom relief and dramatic improvements in symptoms, urinary flow rates, and bladder emptying.
Prostatic artery embolizationProcedure or surgery
Also called PAE
Prostatic artery embolization consists of gaining access into the patients arterial system via a common femoral artery puncture using a small needle and sheath. Once the access is established, a micro-catheter is navigated through the arterial system using X-ray guidance into the arteries feeding the prostate. There, small polyvynil alcohol plastic beads are injected to block the blood flow to the prostate. By doing so, the prostate undergoes an ischemic injury and there is reduction in gland size and relief of obstructive symtpoms.
| Study group | Role | What they receive |
|---|---|---|
| Green light PVP | Active comparator | The KTP:YAG laser is based on the principle of passing Nd:YAG laser light through a KTP crystal. This halves the wavelength of the emitted laser to 532 nm and doubles its frequency. The emitted light is a visible green light, which is strongly absorbed by red tissues and hemoglobin; this renders a blood rich organ such as the prostate gland to be an excellent target. Prostate tissue is vaporized leaving an appropriate cavity for voiding. Receives: Procedure: Green light PVP |
| Prostatic Artery Embolization | Active comparator | Prostatic artery embolization consists of gaining access into the patients arterial system via a common femoral artery puncture using a small needle and sheath. Once the access is established, a micro-catheter is navigated through the arterial system using X-ray guidance into the arteries feeding the prostate. There, small polyvynil alcohol plastic beads are injected to block the blood flow to the prostate. By doing so, the prostate undergoes an ischemic injury and there is reduction in gland size and relief of obstructive symtpoms. Receives: Procedure: Prostatic artery embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the patient to void after removal of the urethral catheter
Measured: At 24-hours for PVP green light laser and 1-3 weeks for embolization
Secondary outcomes (5)
Patient subjective satisfaction of both procedures evaluated by the International Prostate Symptom Score (IPSS)
Measured: At 3, 6, and 12 months post treatment
Degree of prostatic size reduction evaluated by MRI
Measured: Preoperatively, 3 months and 12 months.
Change in peak flow rate (Qmax) and
Measured: At 3, 6 and 12 months post treatment
Change in post-void residual urine volume (PVR)
Measured: At 3, 6, and 12 months
Change in prostate specific antigen (PSA)
Measured: At 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate HyperplasiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Victoria Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Elhilali, Royal Victoria Hospital, Canada
- Investigators
- Mostafa Elhilali, MD,PhD,FRCSC, Study chair, Royal Victoria Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006303
- Sponsor's protocol ID
- 13-100-SDR
- Status last verified
- Nov 2014
- First submitted
- 28 Nov 2013
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostatic Artery Embolization Versus 532 nm Green Light Laser Photoselective Vaporization of the Prostate for Treating Catheter-Dependent Patients With Benign Prostatic Hyperplasia: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT02006303
- Acronym / sponsor ID
- 13-100-SDR
- Conditions
- Benign Prostate Hyperplasia, Urinary Retention
- Keywords
- Benign Prostate Hyperplasia, Green light, Photoselective vaporization of the prostate, Prostatic artery embolization, Outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Royal Victoria Hospital, CanadaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Dec 2013 (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 primary objective is to assess whether prostatic artery embolization has a similar efficacy and safety profile as GreenLight PVP in treating patients with urinary retention secondary to benign prostate hyperplasia (BPH). Subjects who consent will be randomized to either the Prostate embolization (PAE) arm or to the GreenLight PVP arm.
The primary endpoint of efficacy of the procedure is measured by the ability of the patient to void. The secondary endpoints recorded will include patients' satisfaction measured by International Prostate Symptom Score (IPSS), peak flow rate (Qmax) and post-void residual urine volume (PVR) and prostate specific antigen (PSA) will be measured at 3, 6, and 12 months post treatment. Also, reduction in prostate volume is considered by MRI preoperatively, 3 months and 12 months.
Detailed description
The primary objective is to assess whether prostatic artery embolization has a similar efficacy and safety profile compared to GreenLight PVP in treating patients with urinary retention secondary to benign prostate hyperplasia (BPH) that have failed medical management.
The target population is composed of subjects referred to the urology department for treatment of BPH who have failed medical treatment, who present with permanent bladder catheterization and who meet the eligibility criteria.
Subjects who consent will be randomized to either the Prostate embolization (PAE) arm or to the GreenLight PVP arm.
The primary endpoint of efficacy of the procedure is measured by the successful removal of bladder catheter and ability of the patient to void. As well, the secondary endpoints recorded will be: International Prostate Symptom Score (IPSS), peak flow rate (Qmax) and post-void residual urine volume (PVP) and prostate specific antigen (PSA) will be measured at 3, 6, and 12 months post treatment. Trans-rectal ultrasound (TRUS) will be performed for measurement of prostate volume for the stratified randomization process. All adverse events will be captured and analyzed. MRI will be performed preoperatively, 3 months and 12 months. Hospital stays after the procedures will not be considered serious adverse events, unless a hospital admission occurs because of a complication of the treatment performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green light PVP | Active comparator | Procedure: Green light PVPThe KTP:YAG laser is based on the principle of passing Nd:YAG laser light through a KTP crystal. This halves the wavelength of the emitted laser to 532 nm and doubles its frequency. The emitted light is a visible green light, which is strongly absorbed by red tissues and hemoglobin; this renders a blood rich organ such as the prostate gland to be an excellent target. Prostate tissue is vaporized leaving an appropriate cavity for voiding. |
| Prostatic Artery Embolization | Active comparator | Procedure: Prostatic artery embolizationProstatic artery embolization consists of gaining access into the patients arterial system via a common femoral artery puncture using a small needle and sheath. Once the access is established, a micro-catheter is navigated through the arterial system using X-ray guidance into the arteries feeding the prostate. There, small polyvynil alcohol plastic beads are injected to block the blood flow to the prostate. By doing so, the prostate undergoes an ischemic injury and there is reduction in gland size and relief of obstructive symtpoms. |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male subjects, over 50 years of age at the time of enrollment.
- Subjects referred to urology for BPH leading to permanent indwelling bladder catheters and are considered poor surgical candidates
- Written informed consent to participate in the study.
- Ability to comply with the requirements of the study procedures
Key exclusion criteria (13 listed)
- Previous surgical treatment for BPH
- Presence of bladder stones
- History of prostate cancer
- Prostate size > 150 g
- History of urethral stenosis or its management
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 |
|---|---|---|
| Green light PVPAlso: XPS (Xcelerated Performance System), PVP, Photoselective vaporization of the prostateThe green light laser has a wavelength of 532 nm which is strongly absorbed by red tissues and hemoglobin; this renders a blood rich organ such as the prostate gland to be an excellent target. The procedure uses the technology of high-powered laser light combined with fiber optics to vaporize the overgrowth of prostate cells quickly and accurately. As the surgeon directs the laser at the prostate, the intense pulses of light emitted from the fiber are absorbed by the blood. Within moments, the temperature of the blood becomes so great it causes the nearby cells to vaporize. Once the procedure is completed, patients have immediate post-operative symptom relief and dramatic improvements in symptoms, urinary flow rates, and bladder emptying. | Procedure or surgery | Green light PVP |
| Prostatic artery embolizationAlso: PAEProstatic artery embolization consists of gaining access into the patients arterial system via a common femoral artery puncture using a small needle and sheath. Once the access is established, a micro-catheter is navigated through the arterial system using X-ray guidance into the arteries feeding the prostate. There, small polyvynil alcohol plastic beads are injected to block the blood flow to the prostate. By doing so, the prostate undergoes an ischemic injury and there is reduction in gland size and relief of obstructive symtpoms. | Procedure or surgery | Prostatic Artery Embolization |
Primary outcome
Ability of the patient to void after removal of the urethral catheter
Time frame: At 24-hours for PVP green light laser and 1-3 weeks for embolization
5 secondary outcomes
Patient subjective satisfaction of both procedures evaluated by the International Prostate Symptom Score (IPSS)
Time frame: At 3, 6, and 12 months post treatment
Degree of prostatic size reduction evaluated by MRI
Time frame: Preoperatively, 3 months and 12 months.
Change in peak flow rate (Qmax) and
Time frame: At 3, 6 and 12 months post treatment
Change in post-void residual urine volume (PVR)
Time frame: At 3, 6, and 12 months
Change in prostate specific antigen (PSA)
Time frame: At 3, 6, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
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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.
Mostafa Elhilali, MD,PhD,FRCSC study chair
Royal Victoria Hospital, Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Green light PVP and Prostatic artery embolization in people with Benign Prostate Hyperplasia and Urinary Retention, run by Royal Victoria Hospital, Canada at 2 sites 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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Elhilali, MD,PhD,FRCSC (1- 514- 843-1516, mostafa.elhilali@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of the patient to void after removal of the urethral catheter (time frame: At 24-hours for PVP green light laser and 1-3 weeks for embolization). 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 4 Nov 2014.