Ongoing Clinical Trials

Protox Therapeutics has initiated a Phase 2a clinical trial for patients with moderate to severe benign prostatic hyperplasia (BPH) using PRX302.

In this study up to 30 patients will receive a volume of PRX302 dosing solution equivalent to 10, 20 or 30 percent of the total prostate volume. A fixed concentration of PRX302 (3µg/ml) will be delivered in 3 distinct deposition points along the urethra through a single ultrasound-guided transperineal injection into each lobe of the prostate. Therapeutic activity will be assessed based on symptomatic relief, prostate shrinkage and uroflow measurements at 3 months following a single treatment with PRX302.

Protox Therapeutics has initiated a Phase 2a clinical trial for patients with localized recurrent prostate cancer using PRX302.

A total of up to 30 patients with recurrent localized prostate cancer following primary radiation therapy will be enrolled in this Phase 2a, single-arm, open-label, multi-centre study. The trial is designed to determine the optimal injection regimen that provides the maximal therapeutic benefit, while maintaining safety and tolerability of a single intra-prostatic treatment of PRX302. By increasing the volume and/or number of deposits, it is anticipated that the treatment effects of PRX302 may extend to larger volumes of the prostate and, consequently, enhance its therapeutic activity. Measure of therapeutic activity will be based on changes in PSA levels, PSA doubling time and tumour burden.

For more information about this trial, please contact:

Nina Merchant
VP, Development and Regulatory Affairs
nmerchant@protoxtherapeutics.com