Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081481
• Other study ID #: PRX302-2-08
• Status: Completed
• Phase: Phase 2
• Start date: June 7, 2017
• Est. completion date: April 5, 2019

Study information

• Verified date: April 2019
• Source: Sophiris Bio Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 5, 2019
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• PRX302
Single prostate cancer lesion injected with PRX302

Locations

Country	Name	City	State
United Kingdom	Princess Alexandra Hospital	Harlow
United Kingdom	Imperial College	London
United Kingdom	University College Hospital (UCLH)	London
United Kingdom	University Hospital Southampton	Southampton
United States	Chesapeake Urology Associates	Baltimore	Maryland
United States	New York Urology Associates	New York	New York
United States	Vantage Health	Ocala	Florida
United States	Baylor Scott & White Memorial Hospital and Clinic	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sophiris Bio Corp

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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