Dose Escalation Study With QLT0074 for Benign Prostatic Hyperplasia

Summary

The primary objective of this study is to assess the safety and tolerance of transurethral photodynamic therapy (PDT) with QLT0074. Secondary objectives are: 1. To determine if transurethral PDT with QLT0074 has a therapeutic effect on benign prostatic hyperplasia (BPH), evaluated by the American Urological Association Symptom Index (AUA SI), urinary flow rate (Qmax), and post-void residual volume (PVR). 2. To determine the extent of systemic exposure to QLT0074 following transurethral intraprostatic injection. 3. To select up to two transurethral PDT drug-light regimens for further clinical development.

Timeline

Start

2003-03

Primary completion

2005-05

Completion

2005-05

Drugs

Indications