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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: PRX302

• Registration Number: NCT02499848
• Lead Sponsor: Sophiris Bio Corp

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-06-30
• Study Start: 2015-07
• Study First Submitted QC: 2015-07-13
• Study First Posted: 2015-07-16
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraprostatic administration	PRX302	PRX302

Primary Outcome Measures

Name	Time	Method
safety and tolerability of a single injection of PRX302 in all patients will be assessed by recording Adverse Event assessments over 24 weeks	Week 24

Secondary Outcome Measures

Name	Time	Method
To evaluate the potential efficacy of PRX302 by • Transperineal targeted biopsy performed of the treated area at 24 weeks post-treatment	Week 24

Trial Locations

Locations (1)

UCLH; 🇬🇧 London, United Kingdom