Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer

• Status: Completed
• Trial end date: 2019-04-05
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine a safe, effective, and tolerable dose of PRX302 for the treatment of low to intermediate risk prostate cancer.

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

Details

• Lead Sponsor: Sophiris Bio Corp

Criteria

Inclusion Criteria:

• Life expectancy ≥ 10 years.

• Serum prostate-specific antigen (PSA) ≤ 15ng/mL.

• A histologically proven, clinically significant lesion visible on mpMRI (magnetic resonance imaging) that is accessible to PRX302 transperineal injection.

• Radiological stage T1-T2 N0 Mx/M0 disease.

• Targeted prostate biopsy within 6 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion.

Exclusion Criteria:

• Previous radiation therapy to the pelvis.

• Androgen suppression or anti-androgen therapy within the 12 months prior to dosing, for prostate cancer.

• Use of 5-alpha reductase inhibitor within the 3 months prior to dosing.

• Evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging.

• Inability to tolerate transrectal ultrasound (TRUS).

• Known allergy to latex or gadolinium (Gd).

• Prior rectal surgery preventing insertion of the TRUS probe.

• Any previous ablative procedures performed on the prostate, e.g., electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, photochemical, thermal or microwave therapy to treat cancer of the prostate.

• Unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc., likely to contribute significant artifact to images).