Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Sophiris Bio Corp

ClinicalTrials.gov Identifier:

NCT01454349

First received: September 27, 2011

Last updated: May 13, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 27, 2011

Last Updated Date

May 13, 2013

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Safety of PRX302
Tolerability [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Tolerability of PRX302

Original Primary Outcome Measures ^ICMJE

Safety [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Safety of PRX302 will be monitored during routine visits and assessed by physical exam, 12-Lead ECG, vital signs, serum and urine analysis, Prostate-Specific Antigen (PSA), anti-PRX302 antibodies, PRX302 hypersensitivity monitoring, International Index of Erectile Function - Erectile Function Domain (IIEF-EF), New York Heart Association Functional Classification and adverse events at Month 3 compared to baseline and placebo controls.
Tolerability [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Tolerability of PRX302 will be monitored during routine visits and assessed by physical exam, 12-Lead ECG, vital signs, serum and urine analysis, Prostate-Specific Antigen (PSA), anti-PRX302 antibodies, PRX302 hypersensitivity monitoring, International Index of Erectile Function - Erectile Function Domain (IIEF-EF), New York Heart Association Functional Classification and adverse events at Month 3 compared to baseline and placebo controls.

Change History

Complete list of historical versions of study NCT01454349 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Efficacy of PRX302 assessed by International Prostate Symptom Score (IPSS)
Efficacy [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Efficacy of PRX302 assessed by Qmax
Pharmacokinetics [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Pharmacokinetics (PK) measurements of PRX302
Safety [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Safety of PRX302
Tolerability [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Tolerability of PRX302
Efficacy [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Efficacy of PRX302 assessed by uroflowmetry (Qmax)
Efficacy [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Efficacy of PRX302 assessed by IPSS

Original Secondary Outcome Measures ^ICMJE

Efficacy [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Efficacy of PRX302 assessed by International Prostate Symptom Score (IPSS), quality of life (QOL), uroflowmetry (Qmax), post-void residual (PVR) and prostate volume (PV) at Month 3 compared to baseline and placebo controls.
Efficacy [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Longer term (12 months) efficacy of PRX302 assessed by IPSS, quality of life, uroflowmetry (Qmax), post-void residual (PVR) and prostate volume (PV) at Month 12 compared to baseline and placebo controls.
Pharmacokinetics [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Pharmacokinetics (PK) measurements of PRX302 will be assessed by taking serum (at baseline, 15 min, 1 hr, 2hr and 4hr post dose)and urine (at baseline, 30min, 1 hr, 2hr, 4hr and day 2) samples during the study. The levels of PRX302 will be compared to baseline and placebo controls.
Safety [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Longer term (12 months) safety of PRX302 assessed during routine visits by physical exam, 12-Lead ECG, vital signs, serum and urine analysis, PSA, anti-PRX302 antibodies, PRX302 hypersensitivity monitoring, IIEF-EF, New York Heart Association Functional Classification and adverse events at Month 12 compared to baseline and placebo controls.
Tolerability [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Longer term (12 months) tolerability of PRX302 assessed during routine visits by physical exam, 12-Lead ECG, vital signs, serum and urine analysis, PSA, anti-PRX302 antibodies, PRX302 hypersensitivity monitoring, IIEF-EF, New York Heart Association Functional Classification and adverse events at Month 12 compared to baseline and placebo controls.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)

Official Title ^ICMJE

A Randomized Dose-Escalation, Multicenter Safety and Efficacy Study of a Single Transrectal Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Benign Prostatic Hyperplasia

Intervention ^ICMJE

Drug: PRX302
Single intraprostatic injection with an ascending dose per cohort of 0.75, 1.5, 3.0, and 6.0 µg/mL
Drug: Placebo
Single intraprostatic injection of matching placebo

Study Arm (s)

Experimental: PRX302
Intervention: Drug: PRX302
Placebo Comparator: Inactive substance
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months
Written informed consent prior to enrollment in the study
IPSS ≥12
Prostate volume of 30 - 100 mL as determined by TRUS
Maximum urine flow (Qmax) of 4 - 15 mL/sec
Refractory, intolerant or refused the use of alpha-blockers and/or 5 alpha-reductase inhibitors
Unwilling or unable to undergo conventional surgical or available minimally invasive treatments
Blood PSA values <10 ng/mL

Exclusion Criteria:

Inability to void at least 125 mL of urine
PVR volume >200 mL
Presence of or history of certain conditions that could interfere with study results or endanger subject
Use of certain prescribed medications that could interfere with study results

Gender

Male

Ages

50 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01454349

Other Study ID Numbers ^ICMJE

PRX302-2-06

Has Data Monitoring Committee

Yes

Responsible Party

Sophiris Bio Corp

Study Sponsor ^ICMJE

Sophiris Bio Corp

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Richard C. Yocum, MD

Sophiris Bio Corp

Information Provided By

Sophiris Bio Corp

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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