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

Launched by SOPHIRIS BIO CORP · Jul 13, 2015

Keywords

ClinConnect Summary

A single center, open label, Phase IIa, Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) prospective development study. The study will treat approximately 20 men who meet the eligibility criteria, and give written informed consent. Safety and Tolerability will be assessed post-treatment at 2 days (phone call), 2 weeks, 6 weeks, 12 weeks, 24 weeks and 26 weeks. Potential Efficacy will be assessed by biopsy at 24 weeks and imaging (MRI) at 2 weeks, 12 weeks and 24 weeks and PSA outcomes at 12 and 24 weeks.

Gender

MALE

Eligibility 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).