Prostate Cancer Clinical Trial
Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer
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.
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.
Eligibility Criteria
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).
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 4 Locations for this study
Ocala Florida, 34474, United States
Baltimore Maryland, 21204, United States
New York New York, 10016, United States
Temple Texas, 76508, United States
Harlow , , United Kingdom
London , , United Kingdom
London , , United Kingdom
Southampton , , United Kingdom
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.