Back to resultsEvaluate, Safety and Tolerability of Intraprostatic PRX302 Administration, Low to Intermediate Risk Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
PRX302
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring MRI Lesion, transperineal injection, prostate biopsies
Eligibility Criteria
Inclusion Criteria:
- Men aged ≥40 years and life expectancy of ≥10 years.
- Serum prostate-specific antigen (PSA) ≤15 ng/mL.
- Transperineal prostate biopsy within 12 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion.
- Radiological stage T1-T2 N0 Mx/M0 disease.
- A visible lesion on mpMRI that is accessible to PRX302 transperineal injection.
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 a 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 a transrectal ultrasound (TRUS).
- Known allergy to latex or gadolinium (Gd).
- Previous electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, 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).
Sites / Locations
- UCLH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intraprostatic administration
Arm Description
PRX302
Outcomes
Primary Outcome Measures
safety and tolerability of a single injection of PRX302 in all patients will be assessed by recording Adverse Event assessments over 24 weeks
Secondary Outcome Measures
To evaluate the potential efficacy of PRX302 by • Transperineal targeted biopsy performed of the treated area at 24 weeks post-treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02499848
Brief Title
Evaluate, Safety and Tolerability of Intraprostatic PRX302 Administration, Low to Intermediate Risk Prostate Cancer
Official Title
Phase IIa Study, Evaluating the Safety and Tolerability of Targeted Intraprostatic Administration of PRX302 With Histologically Proven,Clinically Significant Localised, Low to Intermediate Risk Prostate Cancer Associated With MRI Lesion
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sophiris Bio Corp
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To Evaluate Safety, Tolerability and Potential Efficacy of PRX302 effect on clinically significant localised low to intermediate prostate cancer.
Detailed Description
A single center, open label, Phase IIa, Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) prospective development study. The study will treat approximately 20 men who meet the eligibility criteria, and give written informed consent. Safety and Tolerability will be assessed post-treatment at 2 days (phone call), 2 weeks, 6 weeks, 12 weeks, 24 weeks and 26 weeks. Potential Efficacy will be assessed by biopsy at 24 weeks and imaging (MRI) at 2 weeks, 12 weeks and 24 weeks and PSA outcomes at 12 and 24 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
MRI Lesion, transperineal injection, prostate biopsies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intraprostatic administration
Arm Type
Experimental
Arm Description
PRX302
Intervention Type
Drug
Intervention Name(s)
PRX302
Other Intervention Name(s)
Topsalysin
Intervention Description
Single prostate cancer lesion injected with PRX302.
Primary Outcome Measure Information:
Title
safety and tolerability of a single injection of PRX302 in all patients will be assessed by recording Adverse Event assessments over 24 weeks
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
To evaluate the potential efficacy of PRX302 by • Transperineal targeted biopsy performed of the treated area at 24 weeks post-treatment
Time Frame
Week 24
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men aged ≥40 years and life expectancy of ≥10 years.
Serum prostate-specific antigen (PSA) ≤15 ng/mL.
Transperineal prostate biopsy within 12 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion.
Radiological stage T1-T2 N0 Mx/M0 disease.
A visible lesion on mpMRI that is accessible to PRX302 transperineal injection.
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 a 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 a transrectal ultrasound (TRUS).
Known allergy to latex or gadolinium (Gd).
Previous electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hashim U Ahmed, PhD,FRCS
Organizational Affiliation
Division of Surgery & Interventional Science University College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLH
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Evaluate, Safety and Tolerability of Intraprostatic PRX302 Administration, Low to Intermediate Risk Prostate Cancer
We'll reach out to this number within 24 hrs