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

Sophiris Bio Corp

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: PRX302

Study type

Interventional

Funder types

Industry

Identifiers

NCT02499848

PRX302-2-07

Details and patient eligibility

About

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

Full 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.

Enrollment

18 patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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).