NCT02676544

Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Rhode Island Hospital · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hypertrophy
• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2016-02-08
• Last updated: 2021-07-08

Locations

1 site across 1 country: United States