Clinical trial NCT02566551: Prospective Controlled Randomized Study of PAE vs TURP for BPH Treatment.
Official title: Prospective Controlled Randomized Study of Prostatic Arteries Embolization (PAE) vs Transurethral Resection of the Prostate (TURP) for Benign Prostatic Hyperplasia (BPH) Treatment.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Prostatic artery embolization
Transurethral resection of the prostate
Lead sponsor: Group of Research in Minimally Invasive Techniques
Sponsor class: OTHER
Collaborators: name: Hospital Clínico Universitario Lozano Blesa
name: Universidad de Zaragoza
First posted: 2015-10-02
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Improvement of symptoms
timeFrame: 12 months
Secondary outcomes:
measure: Improvement in QoL
timeFrame: 12 months
measure: Duration of hospitalization post procedure
timeFrame: 3 weeks
measure: Preservation of erectile function
timeFrame: 12 months
Other outcomes:
measure: Maximum urinary flow rate
timeFrame: 12 months
measure: Post-void residual urinary volume
timeFrame: 12 months
measure: Detrusor pressure
timeFrame: 12 months
measure: Mean prostate volume
timeFrame: 12 months
measure: Structural and morphological changes in MRI
timeFrame: 12 months
measure: Prostate specific antigen
timeFrame: 12 months
measure: Overall adverse events
timeFrame: 12 months
measure: Procedure related adverse events
timeFrame: 12 months
Locations:
city: Zaragoza
country: Spain
facility: Hospital Universitario Lozano Blesa
Study officials:
affiliation: University of Zaragoza. Chairman of Radiology
name: Miguel A De Gregorio, PhD
role: PRINCIPAL_INVESTIGATOR
References: