To Evaluate Safety, Tolerability and Potential Efficacy of PRX302 effect on clinically significant localised low to intermediate prostate cancer.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Single prostate cancer lesion injected with PRX302.
UCLH
London, United Kingdom
safety and tolerability of a single injection of PRX302 in all patients will be assessed by recording Adverse Event assessments over 24 weeks
Time frame: Week 24
To evaluate the potential efficacy of PRX302 by • Transperineal targeted biopsy performed of the treated area at 24 weeks post-treatment
Time frame: Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.