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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499848
• Other study ID #: PRX302-2-07
• Status: Completed
• Phase: Phase 2
• First received: June 30, 2015
• Last updated: July 25, 2016
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Sophiris Bio Corp
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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	UCLH	London

Sponsors (1)

Lead Sponsor	Collaborator
Sophiris Bio Corp

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To evaluate the potential efficacy of PRX302 by • Transperineal targeted biopsy performed of the treated area at 24 weeks post-treatment		Week 24	No