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Clinical Trials/NCT03081481
NCT03081481CompletedPhase 2

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

Sophiris Bio Corp8 sites in 2 countries38 target enrollmentStarted: June 7, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
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

Experimental

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (8)

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