Dose Escalation Study With QLT0074 for Benign Prostatic Hyperplasia

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: QLT Inc.

Criteria

• Twenty-seven men with symptomatic BPH despite adequate drug therapy and who are candidates for surgical or minimally invasive treatment will be enrolled in the study.

• Subjects must have an AUA SI >13, Qmax between 5 and 15 mL/sec, and a urethral treatment length between 30 and 65 mm (defined as the length of the urethra between the bladder neck and the edge of the verumontanum distal to the bladder).