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

NCT00889707 | Completed Phase 2 Results

• 1 other identifier: PRX302-2-03
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 9

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).

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia; BPH; Enlarged Prostate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Maximum Urinary Flow Rate (Qmax) From Baseline to 3 Months (Qmax at 3 Months Minus Qmax at Baseline)

  3 months after treatment

Study Arms (2)

Active Drug

EXPERIMENTAL

PRX302

Drug: PRX302

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PRX302 DRUG

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.

Active Drug

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sophiris Bio Corp: lead

Study Sites (9)

Andreou Research

Surrey, British Columbia, V3V 1N1, Canada

Location

CanMed Clinical Research Inc.

Victoria, British Columbia, V8T 5G1, Canada

Location

Dr. Steinhoff Clinical Research

Victoria, British Columbia, V8V 3N1, Canada

Location

Bramalea Medical Centre

Brampton, Ontario, L6T 4S5, Canada

Location

Brantford Urology Research

Brantford, Ontario, N3R 4N3, Canada

Location

Urology Associates / Urology Medical Research

Kitchener, Ontario, N2N 2B9, Canada

Location

The Fe/Male Health Centers

Oakville, Ontario, l6H 3P1, Canada

Location

Anthony Skehan Medicine Professional Corp.

Thunder Bay, Ontario, P7E 6E7, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3A 2T5, Canada

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

PRX302

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Sophiris Bio Corp (formerly Protox Therapeutics)

richard@sophiris.com

858-255-4711

Study Officials

• Peter Pommerville, MD

  CanMed Clinical Reaearch Inc.

  PRINCIPAL INVESTIGATOR

• Mostafa Elhilali, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 29, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: September 1, 2010
• Last Updated: November 21, 2018
• Results First Posted: October 28, 2013

Record last verified: 2018-10

Locations

CA (9)