Benign Prostatic HyperplasiaNCT02566551
Prospective Controlled Randomized Study of PAE vs TURP for BPH Treatment.
A study testing PAE, Gelatin microspheres and TURP in people with Benign Prostatic Hyperplasia, run by Group of Research in Minimally Invasive Techniques at 1 site in Spain.
Trial summary
The purpose of this prospective randomized controlled study is to compare the improvement of symptoms from benign prostatic hyperplasia (BPH) and the improvement of QoL, in patients undergoing prostatic artery embolization (PAE) or conventional transurethral resection of the prostate (TURP). Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- PAE, Gelatin microspheres and TURP
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to May 2019
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients evaluated in the Urology Service because of BPH, candidate to TURP.
- Signed informed consent
- Lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study AND/OR baseline IPSS Score > 13 AND/OR acute urinary retention with impossibility to remove urinary catheter AND/OR BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused Prostate size of at least 50 grams measured by MRI
- Patient must meet ONE of the following criteria:
- Baseline Prostate Specific Antigen (PSA) <4 ng/mL (no prostate biopsy required)
- Baseline PSA >4 ng/mL and ≤10 ng/mL AND free PSA > 15% of total PSA (no prostate biopsy required)
- Baseline PSA >4 ng/mL and ≤10 ng/mL AND free PSA <15% of total PSA AND a negative prostate biopsy result (minimum 12 core biopsy)
- Baseline PSA >10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy)
Who cannot join
- Active urinary tract infection
- Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study
- Biopsy proven prostate or bladder cancer
- The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study:
- Patients with digital rectal examination (DRE) findings suspicious for prostate cancer
- Patients with baseline PSA levels > 10 ng/mL
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- Patients with baseline PSA levels >4 ng/mL and < 10 ng/mL AND free PSA < 15% of total PSA
- Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc)
- Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
- Allergy to iodinated contrast agents
- Hypersensitivity to gelatin products
- Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate
- Known major iliac arterial occlusive disease or any known condition that catheterization of the prostatic arteries or is a contraindication to embolization, as vasospasm, anatomical variations that imply a risk of embolization, bleeding, prostatic arteries diameter inferior to microcatheter profile, pelvic inflammatory disease
- Contraindication to magnetic resonance imaging
- History of prostatitis in the last 5 years, not totally controlled with medical treatment
- History of pelvic irradiation or radical pelvic surgery
- Coagulation disturbances not normalized by medical treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Controlled Randomized Study of Prostatic Arteries Embolization (PAE) vs Transurethral Resection of the Prostate (TURP) for Benign Prostatic Hyperplasia (BPH) Treatment.
The purpose of this prospective randomized controlled study is to compare the improvement of symptoms from benign prostatic hyperplasia (BPH) and the improvement of QoL, in patients undergoing prostatic artery embolization (PAE) or conventional transurethral resection of the prostate (TURP).
Read the detailed description
The purpose of this prospective randomized controlled study is to compare the improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) and the improvement of QoL assessed by QoL questionnaire in patients undergoing prostatic artery embolization (PAE) to patients of similar characteristics undergoing conventional transurethral resection of the prostate (TURP).
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- PAE, Gelatin microspheres, TURP, Bipolar electrosurgery generator
- Keywords
- Prostatic artery embolization, Transurethral resection of the prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAEProcedure or surgery
Also called Prostate artery embolization, Prostate arteries embolization, Embolization of the prostate, Prostatic artery embolization
Embolization of the prostate with gelatin embolization spheres via microcatheterization of the prostatic arteries.
Gelatin microspheresDevice
Also called Embolization microspheres
Gelatin embolization microspheres (300-500 microns) will be used as embolic material for the prostatic artery embolization (PAE) protocol
TURPProcedure or surgery
Also called Transurethral resection of the prostate, Transurethral prostatic resection
Bipolar transurethral resection of the prostate
Bipolar electrosurgery generatorDevice
Also called Transurethral prostatic resection
A bipolar electrosurgery generator will be used to perform transurethral resection of the prostate (TURP)
| Study group | Role | What they receive |
|---|---|---|
| Prostate artery embolization | Experimental | Prostatic artery embolization (PAE) To perform embolization, gelatin microspheres (300-500 microns) will be used in this arm Receives: Procedure: PAE; Device: Gelatin microspheres |
| Transurethral resection of the prostate | Active comparator | Transurethral resection of the prostate (TURP) A bipolar electrosurgery generator will be used to perform TURP Receives: Procedure: TURP; Device: Bipolar electrosurgery generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of symptoms
Improvement (change) of symptoms assessed by IPSS Score (International Prostate Symptom Score )
Measured: 12 months
Secondary outcomes (3)
Improvement in QoL
Improvement (change) of quality of life assessed by QoL score
Measured: 12 months
Duration of hospitalization post procedure
Number of days of postprocedure hospitalization
Measured: 3 weeks
Preservation of erectile function
Change from baseline in erectile function using the International Index of Erectile Function (IIEF)
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 posted2 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2019 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Group of Research in Minimally Invasive Techniques
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico Universitario Lozano Blesa, Universidad de Zaragoza
- Responsible party
- Principal investigator, José A. Guirola, MD, Group of Research in Minimally Invasive Techniques
- Investigators
- Miguel A De Gregorio, PhD, Principal investigator, University of Zaragoza. Chairman of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566551
- Sponsor's protocol ID
- GTM-02
- Status last verified
- Jul 2019
- First submitted
- 10 Aug 2015
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Controlled Randomized Study of Prostatic Arteries Embolization (PAE) vs Transurethral Resection of the Prostate (TURP) for Benign Prostatic Hyperplasia (BPH) Treatment.
- ClinicalTrials.gov ID
- NCT02566551
- Acronym / sponsor ID
- GTM-02
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Prostatic artery embolization, Transurethral resection of the prostate
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Group of Research in Minimally Invasive TechniquesUniversity, hospital or other
- Collaborators
- Hospital Clínico Universitario Lozano Blesa, Universidad de Zaragoza
- Study start
- Oct 2015 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 2 Oct 2015 (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 purpose of this prospective randomized controlled study is to compare the improvement of symptoms from benign prostatic hyperplasia (BPH) and the improvement of QoL, in patients undergoing prostatic artery embolization (PAE) or conventional transurethral resection of the prostate (TURP).
Detailed description
The purpose of this prospective randomized controlled study is to compare the improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) and the improvement of QoL assessed by QoL questionnaire in patients undergoing prostatic artery embolization (PAE) to patients of similar characteristics undergoing conventional transurethral resection of the prostate (TURP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate artery embolization | Experimental | Procedure: PAE, Device: Gelatin microspheresProstatic artery embolization (PAE) To perform embolization, gelatin microspheres (300-500 microns) will be used in this arm |
| Transurethral resection of the prostate | Active comparator | Procedure: TURP, Device: Bipolar electrosurgery generatorTransurethral resection of the prostate (TURP) A bipolar electrosurgery generator will be used to perform TURP |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients evaluated in the Urology Service because of BPH, candidate to TURP.
- Signed informed consent
- Lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study AND/OR baseline IPSS Score > 13 AND/OR acute urinary retention with impossibility to remove urinary catheter AND/OR BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused Prostate size of at least 50 grams measured by MRI
- Patient must meet ONE of the following criteria:
Key exclusion criteria (17 listed)
- Active urinary tract infection
- Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study
- Biopsy proven prostate or bladder cancer
- The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study:
- Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, 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 |
|---|---|---|
| PAEAlso: Prostate artery embolization, Prostate arteries embolization, Embolization of the prostate, Prostatic artery embolizationEmbolization of the prostate with gelatin embolization spheres via microcatheterization of the prostatic arteries. | Procedure or surgery | Prostate artery embolization |
| Gelatin microspheresAlso: Embolization microspheresGelatin embolization microspheres (300-500 microns) will be used as embolic material for the prostatic artery embolization (PAE) protocol | Device | Prostate artery embolization |
| TURPAlso: Transurethral resection of the prostate, Transurethral prostatic resectionBipolar transurethral resection of the prostate | Procedure or surgery | Transurethral resection of the prostate |
| Bipolar electrosurgery generatorAlso: Transurethral prostatic resectionA bipolar electrosurgery generator will be used to perform transurethral resection of the prostate (TURP) | Device | Transurethral resection of the prostate |
Primary outcome
Improvement of symptoms
Time frame: 12 months
Improvement (change) of symptoms assessed by IPSS Score (International Prostate Symptom Score )
3 secondary outcomes
Improvement in QoL
Time frame: 12 months
Duration of hospitalization post procedure
Time frame: 3 weeks
Preservation of erectile function
Time frame: 12 months
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 12 Jul 2019.
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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.
Miguel A De Gregorio, PhD principal investigator
University of Zaragoza. Chairman of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAE, Gelatin microspheres and TURP in people with Benign Prostatic Hyperplasia, run by Group of Research in Minimally Invasive Techniques at 1 site in Spain.
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 8 inclusion and 17 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 12 Jul 2019. 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 Spain. 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.
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?
Improvement of symptoms (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 12 Jul 2019.