Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: PRX302

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Harlow, United Kingdom
    • Princess Alexandra Hospital
  • London, United Kingdom
    • Imperial College
  • London, United Kingdom
    • University College Hospital (UCLH)
  • Southampton, United Kingdom
    • University Hospital Southampton
• United States
  • Florida
    • Ocala, Florida, United States, 34474
      • Vantage Health
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Chesapeake Urology Associates
  • New York
    • New York, New York, United States, 10016
      • New York Urology Associates
  • Texas
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Memorial Hospital and Clinic

Participation Criteria

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:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PRX302; intraprostatic administration	Drug: PRX302; Single prostate cancer lesion injected with PRX302; Other Names: Topsalysin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	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	26 weeks post administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	Clinically significant disease is defined as Gleason 7, or in the presence of Gleason 3+3 a maximum cancer core length > 6 mm	24 weeks post administration

Collaborators and Investigators

• Sponsor: Sophiris Bio Corp
• Investigators: Principal Investigator: Hashim U Ahmed, MD, Imperial College London

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 7, 2017
• Primary Completion (ACTUAL): November 28, 2018
• Study Completion (ACTUAL): April 5, 2019

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (ACTUAL): March 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Intraprostatic; Prostate biopsies; MRI lesion
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PRX302-2-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No