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

July 25, 2016 updated by: Sophiris Bio Corp

Phase IIa Study, Evaluating the Safety and Tolerability of Targeted Intraprostatic Administration of PRX302 With Histologically Proven,Clinically Significant Localised, Low to Intermediate Risk Prostate Cancer Associated With MRI Lesion

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraprostatic administration
PRX302
Drug: PRX302
Single prostate cancer lesion injected with PRX302.
Other Names:
  • Topsalysin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the potential efficacy of PRX302 by • Transperineal targeted biopsy performed of the treated area at 24 weeks post-treatment
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sophiris Bio Corp

Investigators

  • Principal Investigator: Hashim U Ahmed, PhD,FRCS, Division of Surgery & Interventional Science University College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

July 13, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRX302-2-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on PRX302

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe