Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer

Launched by SOPHIRIS BIO CORP · Mar 15, 2017

Keywords

ClinConnect Summary

A multi-centre, open label, phase IIb study, evaluating the safety, tolerability and efficacy of a targeted intraprostatic focal administration in development. The study will treat approximately 40 men who meet the eligibility criteria, and give written consent. Safety and tolerability will be assessed post-treatment over 26 weeks. Efficacy will be assessed by biopsy and imaging (mpMRI) at 24 weeks.

Gender

MALE

Eligibility 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).