A Phase 2 interventional study of PRX302 in Prostate Cancer, sponsored by Sophiris Bio Corp. Completed at 8 sites in 2 countries. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-04-10.
Sponsored by Sophiris Bio Corp · Phase 2, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 38 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Sophiris Bio Corp is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
intraprostatic administration
Drug: PRX302
Single prostate cancer lesion injected with PRX302
Also known as: Topsalysin
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
Plan to share: No
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Sophiris Bio Corp