Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)
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|ClinicalTrials.gov Identifier: NCT02676544|
Recruitment Status : Recruiting
First Posted : February 8, 2016
Last Update Posted : March 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hypertrophy Lower Urinary Tract Symptoms||Device: Embosphere microspheres||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||July 2021|
Experimental: Embosphere microspheres
Embospheres are calibrated microspheres which will be percutaneously delivered intra-arterially via a microcatheter under fluoroscopic guidance to occlude the prostatic arteries.
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.
- Clinical Improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 24 months ]Questionnaire
- Number of participants with treatment-related adverse events [ Time Frame: 12 months ]Safety and Tolerability as assess by CTCAE 4.0
- Change in peak urinary flow (Qmax) [ Time Frame: 24 months ]Urodynamics
- Change in prostate size [ Time Frame: 24 months ]Imaging (MRI or Transrectal ultrasound)
- Change in serum PSA from baseline [ Time Frame: 24 months ]Blood test
- Erectile and sexual function questionnaire [ Time Frame: 24 months ]Questionnaire
- Pain [ Time Frame: 12 months ]Pain Questionnaire
- Post void residual bladder volume (PVR) [ Time Frame: 24 months ]Imaging (ultrasound)
- Procedural time in minutes [ Time Frame: 1 day ]Total PAE time for informational purposes
- Total fluoroscopy time in minutes [ Time Frame: 1 day ]Total procedural fluoroscopy time in minutes for informational purposes
- Size of catheter used for embolization [ Time Frame: 1 day ]Microcatheter size for informational purposes
- Volume of contrast used in mL [ Time Frame: 1 day ]For informational purposes
- Length of hospital stay [ Time Frame: 1 day ]Expected to be less than 1 day
- Volume of embolic material used in mL [ Time Frame: 1 day ]Total volume per prostatic artery utilized to achieve stasis
- Total fluoroscopy dose mGy [ Time Frame: 1 day ]Measured in mGy for informational purposes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676544
|Contact: Susan M Foley, RTRCV, CCRPfirstname.lastname@example.org|
|Contact: Wendy J Smith, BS, RTRCV, CCRPemail@example.com|
|United States, Rhode Island|
|Rhode Island Hospital||Recruiting|
|Providence, Rhode Island, United States, 02903|
|Contact: Susan M Foley, RTRCV, CCRP 401-444-2980 firstname.lastname@example.org|
|Contact: Wendy J Smith, BS, RTRCV, CCRP 401-444-4233 email@example.com|