Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)

Lower Urinary Tract Symptoms Clinical Trial

Official title:

Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02676544
• Other study ID #: 803676
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: December 2015
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Benign Prostatic Hypertrophy
• Hypertrophy
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Device:
• Embosphere microspheres
This is a clinical trial assessing the feasibly and safety of prostate artery embolization (PAE) for benign prostatic hypertrophy (BPH) resulting in severe lower urinary tract symptoms (LUTS) in patients with gland size =90 grams who are TURP ineligible or non-operative candidates with Embosphere microspheres.

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedural time in minutes	Total PAE time for informational purposes	1 day
Other	Total fluoroscopy time in minutes	Total procedural fluoroscopy time in minutes for informational purposes	1 day
Other	Size of catheter used for embolization	Microcatheter size for informational purposes	1 day
Other	Volume of contrast used in mL	For informational purposes	1 day
Other	Length of hospital stay	Expected to be less than 1 day	1 day
Other	Volume of embolic material used in mL	Total volume per prostatic artery utilized to achieve stasis	1 day
Other	Total fluoroscopy dose mGy	Measured in mGy for informational purposes	1 day
Primary	Clinical Improvement in Lower Urinary Tract Symptoms (LUTS)	Questionnaire	24 months
Secondary	Number of participants with treatment-related adverse events	Safety and Tolerability as assess by CTCAE 4.0	12 months
Secondary	Change in peak urinary flow (Qmax)	Urodynamics	24 months
Secondary	Change in prostate size	Imaging (MRI or Transrectal ultrasound)	24 months
Secondary	Change in serum PSA from baseline	Blood test	24 months
Secondary	Erectile and sexual function questionnaire	Questionnaire	24 months
Secondary	Pain	Pain Questionnaire	12 months
Secondary	Post void residual bladder volume (PVR)	Imaging (ultrasound)	24 months