Evaluate, Safety and Tolerability of Intraprostatic PRX302 Administration, Low to Intermediate Risk Prostate Cancer

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

To Evaluate Safety, Tolerability and Potential Efficacy of PRX302 effect on clinically significant localised low to intermediate prostate cancer.

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

Details

• Lead Sponsor: Sophiris Bio Corp

Criteria

Inclusion Criteria:

• Men aged ≥40 years and life expectancy of ≥10 years.

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

• Transperineal prostate biopsy within 12 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion.

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

• A visible lesion on mpMRI that is accessible to PRX302 transperineal injection.

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 a 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 a transrectal ultrasound (TRUS).

• Known allergy to latex or gadolinium (Gd).

• Previous electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, 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).