Transperineal Intraprostatic Injection of PRX302 Under Ultrasound Guidance for Management of Prostatic Hyperplasia (TRIUMPH-1)

A Randomized, Double-blind, Placebo-controlled Phase II Study of Transperineal Intraprostatic Injection of PRX302 for the Treatment of Benign Prostatic Hyperplasia

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).

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: PRX302; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 1N1
      • Andreou Research
    • Victoria, British Columbia, Canada, V8T 5G1
      • CanMed Clinical Research Inc.
    • Victoria, British Columbia, Canada, V8V 3N1
      • Dr. Steinhoff Clinical Research
  • Ontario
    • Brampton, Ontario, Canada, L6T 4S5
      • Bramalea Medical Centre
    • Brantford, Ontario, Canada, N3R 4N3
      • Brantford Urology Research
    • Kitchener, Ontario, Canada, N2N 2B9
      • Urology Associates / Urology Medical Research
    • Oakville, Ontario, Canada, L6H 3P1
      • The Fe/Male Health Centers
    • Thunder Bay, Ontario, Canada, P7E 6E7
      • Anthony Skehan Medicine Professional Corp.
  • Quebec
    • Montreal, Quebec, Canada, H3A 2T5
      • McGill University Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; PRX302 will be administered at a volume equivalent to 20% of the prostate volume and at a fixed concentration. Treatment will be administered through 1 injection into the transition zone of each lobe of the prostate. A minimum of 2 deposits will be made in the transition zone into each of the right and left lobes of the prostate, with a minimum of 1.0 mL per deposit.
Experimental: Active Drug; PRX302	Drug: PRX302; PRX302 will be administered at a volume equivalent to 20% of the prostate volume and at a fixed concentration. Treatment will be administered through 1 injection into the transition zone of each lobe of the prostate. A minimum of 2 deposits will be made in the transition zone into each of the right and left lobes of the prostate, with a minimum of 1.0 mL per deposit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	3 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximum Urinary Flow Rate (Qmax) From Baseline to 3 Months (Qmax at 3 Months Minus Qmax at Baseline)	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.	3 months after treatment

Collaborators and Investigators

• Sponsor: Sophiris Bio Corp
• Investigators: Principal Investigator: Peter Pommerville, MD, CanMed Clinical Reaearch Inc.; Principal Investigator: Mostafa Elhilali, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: April 27, 2009
• First Submitted That Met QC Criteria: April 28, 2009
• First Posted (Estimate): April 29, 2009

Study Record Updates

• Last Update Posted (Actual): November 21, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia; BPH; Enlarged Prostate
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: PRX302-2-03