Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer

Sophiris Bio Corp

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: PRX302

Study type

Interventional

Funder types

Industry

Identifiers

NCT03081481

PRX302-2-08

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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).