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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Single prostate cancer lesion injected with PRX302
Vantage Health
Ocala, Florida, United States
Chesapeake Urology Associates
Baltimore, Maryland, United States
New York Urology Associates
New York, New York, United States
Baylor Scott & White Memorial Hospital and Clinic
Temple, Texas, United States
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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
Time frame: 26 weeks post administration
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]
Clinically significant disease is defined as Gleason 7, or in the presence of Gleason 3+3 a maximum cancer core length \> 6 mm
Time frame: 24 weeks post administration
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Princess Alexandra Hospital
Harlow, United Kingdom
Imperial College
London, United Kingdom
University College Hospital (UCLH)
London, United Kingdom
University Hospital Southampton
Southampton, United Kingdom