Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer
- Registration Number
- NCT03081481
- Lead Sponsor
- Sophiris Bio Corp
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 38
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PRX302 PRX302 intraprostatic administration
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 26 weeks post administration 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
- Secondary Outcome Measures
Name Time Method 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] 24 weeks post administration Clinically significant disease is defined as Gleason 7, or in the presence of Gleason 3+3 a maximum cancer core length \> 6 mm
Trial Locations
- Locations (8)
Chesapeake Urology Associates
🇺🇸Baltimore, Maryland, United States
Imperial College
🇬🇧London, United Kingdom
New York Urology Associates
🇺🇸New York, New York, United States
Princess Alexandra Hospital
🇬🇧Harlow, United Kingdom
University College Hospital (UCLH)
🇬🇧London, United Kingdom
Vantage Health
🇺🇸Ocala, Florida, United States
Baylor Scott & White Memorial Hospital and Clinic
🇺🇸Temple, Texas, United States
University Hospital Southampton
🇬🇧Southampton, United Kingdom