Multi-Centre, Ph IIb Study, Evaluating Safety & Efficacy of Targeted Intraprostatic Admin of PRX302 to Treat Men With Histologically Proven, Clinically Significant, Localised Prostate Cancer Associated With MRI Lesion
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Sophiris Bio Corp
- Enrollment
- 38
- Locations
- 8
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
PRX302
intraprostatic administration
Intervention: PRX302 (Drug)
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 26 weeks post administration
Treatment-emergent adverse events (TEAEs), including both serious and non-serious AEs, and assessments of severity and relatedness to both the study drug agent (PRX302) and the rest of the injection procedure
Secondary Outcomes
- Proportion of patients with an absence of clinically significant prostate cancer in the targeted area at 24 weeks post-administration of PRX302, as determined by a transperineal targeted biopsy [Efficacy](24 weeks post administration)