Transperineal Intraprostatic Injection of PRX302 Under Ultrasound Guidance for Management of Prostatic Hyperplasia

Phase 2

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: Placebo; Drug: PRX302

• Registration Number: NCT00889707
• Lead Sponsor: Sophiris Bio Corp

Brief Summary

The purpose of this study is to determine whether PRX302 is safe and effective in the treatment of moderate to severe Benign Prostatic Hyperplasia (BPH).

Detailed Description

This is a randomized, double-blinded, placebo-controlled study of transperineal intraprostatic injection of PRX302 under sonographic guidance. Subjects will be randomly assigned to the two treatment groups in a ratio of 2:1 between PRX302 and Placebo, stratified by prostate size and baseline IPSS.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Primary Completion: 2009-12
• Study Completion: 2010-09
• Results First Submitted: 2013-05-28
• Results First Submitted QC: 2013-08-19
• Results First Posted: 2013-10-28
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 92

Inclusion Criteria

• Males aged 40 to 80 years;
• Lower urinary tract symptoms (LUTS), such as frequency, nocturia, urgency, weak urine stream, hesitancy, intermittency or post-void dribbling attributable to BPH for at least 6 months prior to dosing;
• Untreated, intolerant or refractory to α-blockers; should not have received the medication for at least 2 weeks prior to screening and 4 weeks prior to dosing;
• Subjects with PSA values 4 - 10 ng/mL should be assessed or medical records checked (e.g. biopsy report) to rule out the presence of prostate cancer;
• Untreated, intolerant or intolerant to 5-α reductase inhibitors AND must be off medication for at least 6 months prior to dosing;
• IPSS of 15 or higher;
• Prostate volume at screening estimated at 30 to 100 mL as determined by TRUS;
• Provided written Informed Consent for participation in the study.

Exclusion Criteria

• Maximum urine flow rate (Qmax) of greater than 12 mL/sec;

• Inability to void at least 150 mL of urine;

• Post voiding residual urine volume (PVR) of greater than 200 mL;

• Subjects unable to stand to void;

• Subjects with acute or chronic bacterial prostatitis;

• Using drugs (e.g. estrogen, androgen) that can produce androgen depression or anabolic steroids;

• Penile prosthesis or artificial urinary sphincter;

• Presence of prostatic cyst larger than 1 cm in diameter;

• Unwilling to use condoms for 3 weeks post-treatment to prevent pregnancy and to avoid semen contact with partner(s);

• Urethral stricture disease;

• Bladder neck abnormalities/strictures;

• Significant median lobe hyperplasia that contributes to outflow obstruction;

• Confirmed or suspected neurogenic bladder dysfunction;

• Systemic neurological disorders that may affect voiding function;

• Previous pelvic surgery, trauma or radiation;

• Active genitourinary infection within 7 days before screening;

• Significant renal dysfunction (as evidenced by a serum creatinine > 1.6 mg/dL on the screening laboratory evaluation);

• Abnormal liver function as evidenced by any of the following abnormal laboratory values being greater than 1.5 upper limit of normal (ULN) at screening:

  • alkaline phosphatase (ALP);
  • total bilirubin;
  • alanine transferase (ALT); and/or
  • aspartate aminotransferase (AST);

• Abnormal Prothrombin Time (PT > 13 sec) / International Normalized Ratio (INR > 1.2);

• Severe cardiovascular or hepatic disease (American Society of Anesthesiologists [ASA] > 3); Presence of suspected or confirmed malignancy other than non-melanomatous, cutaneous malignancies which have undergone curative interventions;

• Receiving anticoagulants (Subjects receiving anticoagulants may be enrolled after discontinuation of anticoagulant therapy and return of INR level to within normal limits (INR < 1.2) before dosing day. Subjects receiving platelet inhibitors (including garlic) must be off the inhibitors for at least 6 days or more. Subjects unable to discontinue anticoagulant therapy may not be enrolled in this study);

• Subjects who have received any treatment for BPH other than α-blockers, 5-α reductase inhibitors or phytotherapy;

• Subjects taking α-blockers and phytotherapy within 2 weeks of screening and 4 weeks of dosing;

• Subjects receiving 5-α reductase inhibitors within 6 months of dosing;

• Subjects taking part in other experimental programs prior to the start of the study or during the study period;

• Any medical, psychological or other condition or medical history of the subject that, in the opinion of the Investigator or the Sponsor's Medical Monitor, unduly increases the risk of subject's participation or that would unnecessarily confound the data to be collected in this study;

• Unable or unwilling to comply with the requirements of the protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Active Drug	PRX302	PRX302

Primary Outcome Measures

Name	Time	Method
Change in International Prostate Symptom Scale (IPSS) of Lower Urinary Tract Symptoms From Baseline to 3 Months (Total Score at 3 Months Minus Total Score at Baseline)	3 months post-treatment	Total of 7 questions regarding lower urinary tract symptoms, with each question scored on a range of 0 (not at all) to 5 (almost always have the symptom). The total score is the summation of all 7 questions, and therefore has a possible range of 0 to 35.

Secondary Outcome Measures

Name	Time	Method
Change in Maximum Urinary Flow Rate (Qmax) From Baseline to 3 Months (Qmax at 3 Months Minus Qmax at Baseline)	3 months after treatment	A printout of uroflowmetry was provided to a central, blinded, independent reviewer for determination of the Qmax values to be used for evaluation of efficacy. The central, independent, blinded reviewer determined the Qmax from over-reads of the uroflowmetry printouts, applying the 2-second rule to reduce variability and increase the accuracy.

Trial Locations

Locations (9)

The Fe/Male Health Centers; 🇨🇦 Oakville, Ontario, Canada

Brantford Urology Research; 🇨🇦 Brantford, Ontario, Canada

Urology Associates / Urology Medical Research; 🇨🇦 Kitchener, Ontario, Canada

Bramalea Medical Centre; 🇨🇦 Brampton, Ontario, Canada

Dr. Steinhoff Clinical Research; 🇨🇦 Victoria, British Columbia, Canada

Andreou Research; 🇨🇦 Surrey, British Columbia, Canada

Anthony Skehan Medicine Professional Corp.; 🇨🇦 Thunder Bay, Ontario, Canada

CanMed Clinical Research Inc.; 🇨🇦 Victoria, British Columbia, Canada

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada