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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: PRX302


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraprostatic administration<br>PRX302 | Drug: PRX302<br>* Single prostate cancer lesion injected with PRX302.<br>* Other names: Topsalysin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | Week 24 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI Lesion, transperineal injection, prostate biopsies