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

S

Sophiris Bio Corp

Status and phase

Completed
Phase 2
Phase 1

Conditions

Benign Prostatic Hyperplasia

Treatments

Drug: Placebo
Drug: PRX302

Study type

Interventional

Funder types

Industry

Identifiers

NCT01454349
PRX302-2-06

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Male

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

PRX302
Experimental group
Treatment:
Drug: PRX302
Inactive substance
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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