Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH (PLUS-1)

Sophiris Bio Corp

Status and phase: Completed; Phase 3

Conditions: Benign Prostatic Hyperplasia

Treatments: Other: Placebo; Drug: PRX302

Study type: Interventional

Funder types: Industry

Identifiers

NCT01966614

PRX302-3-01

Details and patient eligibility

About

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

Enrollment: 479 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥50 years
• Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months
• IPSS ≥15
• Maximum urine flow (Qmax) of 5 - 15 mL/sec
• Prostate volume of 30 - 100 mL as determined by TRUS
• Serum prostate-specific antigen (PSA) values <10 ng/mL
• Post-void residual (PVR) <= 200 mL

Exclusion criteria

• Inability to void ≥125 mL urine
• Prior surgery/MIST for BPH
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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479 participants in 2 patient groups, including a placebo group

PRX302

Experimental group

Description:

PRX302 injection

Treatment:

Drug: PRX302

Placebo

Placebo Comparator group

Description:

Placebo (Vehicle-only injection)

Treatment:

Other: Placebo