Prostate Cancer
Conditions
Keywords
Intraprostatic, MRI lesion, Prostate biopsies
Brief 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.
Detailed 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.
Interventions
DRUGPRX302
Single prostate cancer lesion injected with PRX302
Sponsors
Sophiris Bio Corp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 26 weeks post administration | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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] | 24 weeks post administration | Clinically significant disease is defined as Gleason 7, or in the presence of Gleason 3+3 a maximum cancer core length \> 6 mm |
Countries
United Kingdom, United States
Outcome results
None listed