Prospective Controlled Randomized Study of PAE vs TURP for BPH Treatment.

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Prospective Controlled Randomized Study of Prostatic Arteries Embolization (PAE) vs Transurethral Resection of the Prostate (TURP) for Benign Prostatic Hyperplasia (BPH) Treatment.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02566551
• Other study ID #: GTM-02
• Status: Withdrawn
• Phase: N/A
• Start date: October 2015
• Est. completion date: May 2019

Study information

• Verified date: July 2019
• Source: Group of Research in Minimally Invasive Techniques
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

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:

1. Baseline Prostate Specific Antigen (PSA) <4 ng/mL (no prostate biopsy required)

2. Baseline PSA >4 ng/mL and =10 ng/mL AND free PSA > 15% of total PSA (no prostate biopsy required)

3. 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)

4. Baseline PSA >10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy)

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• PAE
Embolization of the prostate with gelatin embolization spheres via microcatheterization of the prostatic arteries.

Device:
• Gelatin microspheres
Gelatin embolization microspheres (300-500 microns) will be used as embolic material for the prostatic artery embolization (PAE) protocol

Procedure:
• TURP
Bipolar transurethral resection of the prostate

Device:
• Bipolar electrosurgery generator
A bipolar electrosurgery generator will be used to perform transurethral resection of the prostate (TURP)

Locations

Country	Name	City	State
Spain	Hospital Universitario Lozano Blesa	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
Group of Research in Minimally Invasive Techniques	Hospital Clínico Universitario Lozano Blesa, Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximum urinary flow rate	Change from baseline in maximum urinary flow rate (Qmax)	12 months
Other	Post-void residual urinary volume	Change from baseline in post-void residual urinary volume (PVR)	12 months
Other	Detrusor pressure	Change from baseline in detrusor pressure (Pdet)	12 months
Other	Mean prostate volume	Change from baseline in mean prostate volume, as determined by transrectal US	12 months
Other	Structural and morphological changes in MRI	Change from baseline in mean prostate volume, and structural and morphological changes as determined by MRI	12 months
Other	Prostate specific antigen	Change from baseline in prostate specific antigen (PSA)	12 months
Other	Overall adverse events	Overall adverse events	12 months
Other	Procedure related adverse events	Procedure related adverse events	12 months
Primary	Improvement of symptoms	Improvement (change) of symptoms assessed by IPSS Score (International Prostate Symptom Score )	12 months
Secondary	Improvement in QoL	Improvement (change) of quality of life assessed by QoL score	12 months
Secondary	Duration of hospitalization post procedure	Number of days of postprocedure hospitalization	3 weeks
Secondary	Preservation of erectile function	Change from baseline in erectile function using the International Index of Erectile Function (IIEF)	12 months