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Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PRX302
Sponsored by
Sophiris Bio Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Intraprostatic, MRI lesion, Prostate biopsies

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Vantage Health
  • Chesapeake Urology Associates
  • New York Urology Associates
  • Baylor Scott & White Memorial Hospital and Clinic
  • Princess Alexandra Hospital
  • Imperial College
  • University College Hospital (UCLH)
  • University Hospital Southampton

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRX302

Arm Description

intraprostatic administration

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 7, 2017
Last Updated
April 8, 2019
Sponsor
Sophiris Bio Corp
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1. Study Identification

Unique Protocol Identification Number
NCT03081481
Brief Title
Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 7, 2017 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
April 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sophiris Bio Corp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Intraprostatic, MRI lesion, 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
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRX302
Arm Type
Experimental
Arm Description
intraprostatic administration
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
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
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
Secondary Outcome Measure Information:
Title
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]
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hashim U Ahmed, MD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vantage Health
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Chesapeake Urology Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
New York Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Baylor Scott & White Memorial Hospital and Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Princess Alexandra Hospital
City
Harlow
Country
United Kingdom
Facility Name
Imperial College
City
London
Country
United Kingdom
Facility Name
University College Hospital (UCLH)
City
London
Country
United Kingdom
Facility Name
University Hospital Southampton
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer

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