Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Single prostate cancer lesion injected with PRX302

PRX302

Hashim U Ahmed, MD

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.

Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer

Multi-Centre, Ph IIb Study, Evaluating Safety & Efficacy of Targeted Intraprostatic Admin of PRX302 to Treat Men With Histologically Proven, Clinically Significant, Localised Prostate Cancer Associated With MRI Lesion

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

Clinically significant disease is defined as Gleason 7, or in the presence of Gleason 3+3 a maximum cancer core length \> 6 mm

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer	NCT03081481	Prostate Cancer	PRX302	40 Years -	Sophiris Bio Corp
Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer	NCT03081481	Prostate Cancer	PRX302	40 Years -	Sophiris Bio Corp

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