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Urology Practice Management - April 2015, Vol 4, No 2 - Clinical Trials Tracker

The following clinical trials are currently recruiting patients with benign prostatic hyperplasia for inclusion in several investigations. Each trial description includes the NLM Identifier to use as a reference with ClinicalTrials.gov.

  1. Placebo-Controlled Study of Talaporfin Sodium

    This phase 2, double-blind, placebo-controlled study investigates the safety and efficacy of talaporfin sodium that are activated by an intraurethrally placed drug-activating device. Patients who have symptoms of benign prostatic hyperplasia and who are aged ≥45 years, weigh ≤200 kg, have had lower urinary tract symptoms for ≥6 months, and have been stabilized for ≥6 months on 5-alpha reductase inhibitors or ≥3 months with other drugs may enroll if other criteria are met. Patients who have withdrawn from their regularly prescribed medication will require a washout period. Patients are randomized in a 2:2:1:1 ratio to receive a single treatment of talaporfin sodium or saline placebo activated at either a higher or lower dose of light.

    The primary outcome is the International Prostate Symptom Score at 12 weeks, measured as the score change from baseline. Secondary outcome measures include the Modified International Prostate Symptom Score, Patient and Clinical Global Impressions of Improvement, and quality of life. The maximum urinary flow rate, postvoid residual volume, 3-day frequency/volume data, and serum prostate-specific antigen levels are also collected. This study is expected to enroll 192 patients in Anchorage, AK, and Pompano Beach, FL. For more information, contact Maggie Wilson or Sally Rooney at info@contact-clinical-­trials.com. The NLM Identifier is NCT02326454.

  2. Postmarketing Study Using Prolieve

    The objective of this phase 4, open-label, single-group assignment study is to collect safety and effectiveness data for 5 years in patients who are treated with Prolieve, a transurethral microwave therapy device. This data will provide information on long-term treatment effects and time to retreatment. Patients aged ≥18 years with a peak urine flow rate of <12 mL/sec on voided volume of >125 mL and an American Urological Association (AUA) Symptom Score of ≥9 many enroll if other criteria are met. All patients will receive Prolieve throughout the study.

    The primary outcome is the time to retreatment estimated over 5 years. The secondary outcome is the change from baseline in AUA total score at 5 years, based on the number of patients who worsened, had no change (1%-29%), or had ≥30% improvement. A responder analysis will also be conducted on the peak flow rate of each category. This trial is expected to enroll 250 patients at locations throughout the United States. For more information, contact Perry Weiner, DO, FACOS, at 215-503-3300. The NLM Identifier is NCT02021032.

  3. Prostate Artery Embolization versus TURP

    This phase 3, randomized, open-label, parallel-assignment study evaluates symptom improvement in patients who receive prostatic artery embolization (PAE) using Embosphere Microspheres versus conventional transurethral resection of the prostate (TURP). Patients aged 50 to 79 years with lower urinary tract symptoms secondary to benign pro­static hyperplasia for ≥6 months before study treatment, who are refractory to medical treatment or for whom medication is contraindicated, and who have a baseline International Prostate Symptom Score of >13 and a prostate size of 50 to 90 g may enroll if other criteria are met. Patients are randomized to receive either PAE or TURP.

    The primary outcome measure is International Prostate Symptom Score improvement at 12 months postprocedure. Secondary outcome measures include the duration of hospitalization postprocedure, duration of postprocedure catheterization, adverse events, and safety. Other measured outcomes include the change from baseline in peak urine flow rate, erectile function, mean prostate volume, postvoid residual urinary volume, detrusor muscle pressure, and prostate-specific antigen. This study is expected to enroll 186 patients at sites throughout the United States. For more information, contact Melodie Domurad, PhD, at 781-681-7900 or best@merit.com. The NLM Identifier is NCT01789840.

  4. Prostate Artery Embolization Patients

    The objective of this phase 2, open-label, single-group assignment study is to evaluate the safety and efficacy of PAE for the treatment of benign prostatic hyperplasia in patients who have a prostate size >90 g as measured by transrectal ultrasound (TRUS), and who experience lower urinary tract symptoms. Patients aged 50 to 85 years who have an International Prostate Symptom Score of ≥ 13, a peak urine flow rate of <12 mL/sec, who refuse surgical treatment, and who are refractory to or contraindicated for medical treatment may enroll if other criteria are met. All patients will receive PAE with Embosphere Microspheres within 4 weeks of the TRUS.

    The primary outcome measure is the improvement of disease symptoms as assessed by the International Prostate Symptom Score at 12 months postembolization. Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events and findings on physical examination. Follow-up visits will be conducted at 1, 3, 6, and 12 months after PAE. Repeat TRUS and urodynamic tests are conducted at 6- and 12-month follow-up visits. This trial is expected to enroll 30 patients at Tampa General Hospital, FL. For more information, contact Haydy Rojas, RN, at 813-844-5012 or hrojas@tgh.org. The NLM Identifier is NCT02167009.

  5. Prostate Embolization for Benign Prostatic Hyperplasia

    The purpose of this phase 1/2, open-label, prospective, single-­group observational study is to determine the safety of PAE for patients with benign prostatic hyperplasia. Patients aged 50 to 90 years with symptomatic disease for ≥6 months with a prostate enlargement of 50 to 100 cc, and who have symptoms and urinary flow rates that meet entrance criteria may enroll if other conditions are met. All patients will receive embolization with Embosphere Microspheres sized at 300 to 500 μm.

    Primary outcomes measure the evidence of bladder or rectal ischemic injury 1 week after PAE, and detection of bladder or rectal ischemic injury at 3, 6, and 12 months postprocedure; both are assessed via cystoscopy. Patients who experience an adverse event will be scored using Society of Interventional Radiology definitions. Secondary outcomes include improvement in International Prostate Symptom Score, International Index of Erectile Function, and uroflowmetry postembolization at 3, 6, and 12 months, and then annually for 5 years posttreatment. Measurements of the prostate volume, serum prostate-specific antigen, procedure time and radiation parameters, and the percentage of prostate tissue that is devascularized are also collected. This study is expected to enroll 30 patients at MedStar Georgetown University Hospital in Washington, DC. For more information, contact Angela White at 202-444-6825 or amwd@gunet.george town.edu. The NLM Identifier is NCT01924988.


  6. OnaBoNT-A (Botox) versus Oral Tamsulosin

    This phase 2, double-blind, placebo-controlled study compares the treatment effects of onaBoNT-A 200 U versus oral tamsulosin 0.4 mg in veterans who are diagnosed with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia. This investigation will assess whether onaBoNT-A shows potential for treating this condition. Males aged ≥50 years with voided volume >125 mL and a maximum urinary flow rate of <15 mL/sec may enroll if other criteria are met. Patients will be randomized to an onaBoNT-A 1-time injection with placebo oral capsules, or a normal saline 1-time injection into the prostate and tamsulosin 0.4-mg oral capsules. There will be 5 clinic visits and 2 telephone follow-ups throughout the study.

    The primary outcome is the AUA Symptom Score measured for a time frame of 3 months. This trial is expected to enroll 74 patients at the Michael E. DeBakey VA Medical Center in Houston, TX. For more information, contact Sebrina A. Tello at 713-791-1414 (extension 25326) or sebrina.tello@va.gov, or Christopher P. Smith, MD, at 713-791-1414 or christopherp.smith@va.gov. The NLM Identifier is NCT01589263.
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Last modified: April 14, 2015
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