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

NCT ID: NCT02499848

Last Updated: 2016-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-06-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intraprostatic administration

PRX302

Group Type: EXPERIMENTAL

PRX302

Intervention Type: DRUG

Single prostate cancer lesion injected with PRX302.

Interventions

PRX302

Single prostate cancer lesion injected with PRX302.

Intervention Type: DRUG

Other Intervention Names

Topsalysin

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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sophiris Bio Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hashim U Ahmed, PhD,FRCS

Role: PRINCIPAL_INVESTIGATOR

Division of Surgery & Interventional Science University College London

Locations

UCLH

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

PRX302-2-07

Identifier Type: -

Identifier Source: org_study_id