Clinical trial NCT02676544: Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)
Official title: Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Benign Prostatic Hypertrophy
Lower Urinary Tract Symptoms
Keywords: Prostate Artery Embolization (PAE)
Benign Prostatic Hyperplasia (BPH)
Lower Urinary Tract Symptoms (LUTS)
PAE
BPH
LUTS
Prostate Artery Embolization
Embospheres
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2016-02-08
Enrollment: 9
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, open label single center feasibility study to demonstrate basic safety and effectiveness of prostate artery embolization for the treatment of symptomatic benign prostatic Hyperplasia (BPH) in a small series of patients with large (≥90 grams) glands.

Detailed description: This is a prospective, open labeled, non-randomized, single center feasibility study to evaluate the technical and clinical success of prostatic artery embolization utilizing Embosphere microspheres.

At initial consultation patients will be screened to assess the severity of lower urinary tract symptoms (LUTS) related to BPH utilizing the international prostate symptom score (IPSS). After determining eligibility, pre-procedure baseline evaluation will be completed. A baseline prostate ultrasound (TRUS) or MRI will be required to assess prostate mass, and baseline prostate-specific antigen will be measured to help exclude carcinoma and also to follow response to therapy. Patients with suspected malignancy of the prostate will not be enrolled without a negative biopsy finding. Pre- procedure urodynamic studies will be required to assess additional objective measurements and to exclude other causes of LUTS. Cystoscopy will be performed prior to any intervention to help exclude bladder malignancy.

If the patient qualifies by the level of symptoms (IPSS score ≥12), prostate size ≥ 90 grams and max urinary flow rate (Qmax) ≤ 12, the patient will be asked to consider enrolling in the study. A study investigator will review the proposed treatment and baseline/follow-up schedule. If the patient agrees to participate in the study, baseline data will be collected on a case report form and an appointment will be made for prostate artery embolization in the interventional radiology department.

Eligibility criteria: Inclusion Criteria:

* Patients selected for this study must meet all of the following criteria:

  * Age ≥ 50 years
  * Lower urinary tract symptoms secondary to BPH as defined by:
  * IPSS Symptom Index ≥ 12
  * Maximum Uroflow rate (Qmax) of ≤ 12cc per sec
  * Prostate of ≥ 90 gm as determined by MRI or transrectal ultrasound of the prostate (TRUS)

Exclusion Criteria:

* Patients meeting any of the following criteria will be excluded from the study.

  * Age less than 50 years
  * Prostate cancer
  * Bladder cancer
  * Severe, life-threatening allergy to iodinated contrast
  * Bilateral internal iliac artery occlusion
  * Causes of obstruction other than BPH such as stricture disease
  * Neurogenic bladder or other causes of bladder atonia
  * Post void residual greater than 250 cc
  * Any contraindication to embolization, including
  * Patients intolerant to occlusion procedures
  * Vascular anatomy or blood flow that precludes catheter placement or embolic agent injection
  * Presence or likely onset of vasospasm
  * Presence or likely onset of hemorrhage
  * Presence of severe atheromatous disease
  * Presence of feeding arteries smaller than distal branches from which they emerge
  * Presence of collateral vessel pathways potentially endangering normal territories during embolization
  * History of any illness or surgery that might confound the results of the study, which produces symptoms that might be confused with those of the disease process under consideration, or which poses additional risk to the patient.
  * Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
  * Confirmed or suspected bladder cancer
  * Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease
  * Previous pelvic irradiation or radical pelvic surgery
  * Recent (within 3 months) cystolithiasis
  * History or presence of urethral strictures, bladder neck contracture, potentially confounding bladder pathology, or (within 5 years) prostatitis
  * Active urinary tract infection
  * Concomitant medications:

    (i) Use of anti histaminics, anti convulsants, and antispasmodics within 1 week of treatment unless there is documented evidence that the patient has been on the same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study) (ii) Use of alpha blockers, anti-cholinergics, androgens, and gonadotropins-releasing hormonal analogs within 2 months of treatment (iii) Use of 5 alpha reductase inhibitors within 6 months of treatment
  * Compromised renal function (i.e. serum creatinine level greater than 1.8 mg/dl, or upper-tract disease)

Primary outcomes:
measure: Clinical Improvement in Lower Urinary Tract Symptoms (LUTS)
timeFrame: 24 months
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: 12 months
measure: Change in peak urinary flow (Qmax)
timeFrame: 24 months
measure: Change in prostate size
timeFrame: 24 months
measure: Change in serum PSA from baseline
timeFrame: 24 months
measure: Erectile and sexual function questionnaire
timeFrame: 24 months
measure: Pain
timeFrame: 12 months
measure: Post void residual bladder volume (PVR)
timeFrame: 24 months
Other outcomes:
measure: Procedural time in minutes
timeFrame: 1 day
measure: Total fluoroscopy time in minutes
timeFrame: 1 day
measure: Size of catheter used for embolization
timeFrame: 1 day
measure: Volume of contrast used in mL
timeFrame: 1 day
measure: Length of hospital stay
timeFrame: 1 day
measure: Volume of embolic material used in mL
timeFrame: 1 day
measure: Total fluoroscopy dose mGy
timeFrame: 1 day
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References: