NCT02566551

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

2.6 years

First QC Date

August 10, 2015

Last Update Submit

July 11, 2019

Conditions

Benign Prostatic Hyperplasia

Keywords

Prostatic artery embolizationTransurethral resection of the prostate

Outcome Measures

Primary Outcomes (1)

  • Improvement of symptoms

    Improvement (change) of symptoms assessed by IPSS Score (International Prostate Symptom Score )

    12 months

Secondary Outcomes (3)

  • Improvement in QoL

    12 months

  • Duration of hospitalization post procedure

    3 weeks

  • Preservation of erectile function

    12 months

Other Outcomes (8)

  • Maximum urinary flow rate

    12 months

  • Post-void residual urinary volume

    12 months

  • Detrusor pressure

    12 months

  • +5 more other outcomes

Study Arms (2)

Prostate artery embolization

EXPERIMENTAL

Prostatic artery embolization (PAE) To perform embolization, gelatin microspheres (300-500 microns) will be used in this arm

Procedure: PAEDevice: 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

Procedure: TURPDevice: Bipolar electrosurgery generator

Interventions

PAEPROCEDURE

Embolization of the prostate with gelatin embolization spheres via microcatheterization of the prostatic arteries.

Also known as: Prostate artery embolization, Prostate arteries embolization, Embolization of the prostate, Prostatic artery embolization
Prostate artery embolization
Gelatin microspheresDEVICE

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

Also known as: Embolization microspheres
Prostate artery embolization
TURPPROCEDURE

Bipolar transurethral resection of the prostate

Also known as: Transurethral resection of the prostate, Transurethral prostatic resection
Transurethral resection of the prostate
Bipolar electrosurgery generatorDEVICE

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

Also known as: Transurethral prostatic resection
Transurethral resection of the prostate

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Lozano Blesa

Zaragoza, 50003, Spain

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Miguel A De Gregorio, PhD

    University of Zaragoza. Chairman of Radiology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 10, 2015

First Posted

October 2, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2019

Last Updated

July 12, 2019

Record last verified: 2019-07

Locations

ES(1)