Prostate cancer MedDRA version: 19.0 Level: HLT Classification code 10036966 Term: Prostatic neoplasms and hypertrophy System Organ Class: 100000004872
Conditions
Interventions
Product Name: topsalysin
Product Code: PRX302
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Topsalysin
CAS Number: RN917121256
Current Sponsor code: PRX302
Other descriptiv
Sponsors
Sophiris Bio Corp. 1258 Prospect Street La Jolla, CA 92037 USA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men aged =40 years and life expectancy of =10 years. 2. Serum prostate-specific antigen (PSA) =15ng/mL. 3. In the planned treatment zone, histologically proven clinically significant prostate cancer of maximum Gleason Score 7 (3+4 or 4+3) • In the presence of Gleason sum of 7, the MCCL must not exceed 10mm. • In the presence of Gleason sum of 7, there is no minimum cancer core length requirement. • In the presence of Gleason patterns 3+3, the MCCL must exceed 5mm. • In the presence of Gleason sum of 6, the MCCL must not exceed 10mm. 4. Radiological stage T1-T2 N0 Mx/M0 disease. 5. A visible lesion on mpMRI, Prostate Imaging-Reporting and Data System (PI-RADS) (version 2) score 3, 4 or 5 and up to a maximum volume of 1mL that is accessible to administration of PRX302 via transperineal injection. mpMRI to be obtained at the screening visit or within 6 months prior to dosing (using the same MRI magnet strength that will be used for the patient’s in-study mpMRIs). 6. Targeted prostate biopsy within 6 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion. 7. Written informed consent by the patient for participation in the study. 8. Patient has an understanding of the English language sufficient to understand written and verbal information about the study and consent process. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Prostate volume (PV) 1.5 at the time of dosing. 18. Any acute or chronic medical condition that, in the opinion of the Investigator, increases the risk to the patient or the likelihood that the patient will be unable to complete the study. 19. Unable or unwilling to comply with the requirements of the protocol. 20. Participation in any investigational study within 30 days prior to dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of a single, and if applicable a second, administration of PRX302 when used to selectively target and focally ablate histologically proven, clinically significant, localised, low- to intermediate-risk prostate cancer that is associated with an MRI lesion. ;Secondary Objective: To evaluate the efficacy of a single, and if applicable a second, administration of PRX302 to selectively target and focally ablate histologically proven, clinically significant, localised, low- to intermediate-risk prostate cancer that is associated with an MRI lesion, as assessed by biopsy (histological), imaging (MRI) and PSA outcomes.;Primary end point(s): To assess safety and tolerability of a single and if applicable a second administration of PRX302 which will be described by summarizing AEs, concomitant medications, concomitant procedures and changes from baseline in physical examinations, clinical laboratory tests (including PSA), EF-IIEF, IPSS, UCLA-EPIC Urinary domain, and EQ-5D-5L ;Timepoint(s) of evaluation of this end point: Proportion of patients with an absence of clinically significant prostate cancer in the targeted area at 24 weeks post-treatment with a single administration of PRX302, as determined by a transperineal targeted biopsy. (Clinically significant disease is defined as Gleason 7, or in the presence of Gleason 3+3 a maximum cancer core length > 6 mm.) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of patients with an absence of clinically significant prostate cancer in the targeted area as determined by a transperineal targeted biopsy. (Clinically significant disease is defined as Gleason 7, or in the presence of Gleason 3+3 a maximum cancer core length > 6 mm.) • Proportion of patients with no detectable prostate cancer in the targeted area as determined by a transperineal targeted biopsy. • Proportion of patients with no detectable prostate cancer in the targeted area as determined by a transperineal targeted biopsy. • Change from baseline on transperineal targeted biopsy performed of the treated area. • Proportion of patients with the absence of mpMRI-visible disease in the targeted lesion area. • Proportion of patients with a reduction in the volume of mpMRI-visible targeted lesion defined as a = 20% volume reduction. • Ability of mpMRI to predict the presence of residual clinically significant prostate cancer seen on biopsy in the targeted lesion area. • Change from baseline in mpMRI parameters (e.g., size of lesion, enhancement properties, diffusion weighted properties, T2-weighted characteristics, Grade 1-5 MRI score). • Change from baseline in serum PSA. • Change from baseline in serum PSA density (PSA in ng/mL divided by prostate volume [PV] in mL).;Timepoint(s) of evaluation of this end point: At 24 weeks post-treatment following a single and if applicable a second administration of PRX302. | — |
Countries
United Kingdom, United States
Contacts
Public ContactAllison Hulme
Sophiris Bio Corp
Outcome results
None listed