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Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03081481
Recruitment Status : Completed
First Posted : March 16, 2017
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Sophiris Bio Corp

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: PRX302 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 7, 2017
Actual Primary Completion Date : November 28, 2018
Actual Study Completion Date : April 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: PRX302
intraprostatic administration
 Drug: PRX302
Single prostate cancer lesion injected with PRX302
Other Name: Topsalysin


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 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 Outcome Measures :
  1. 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] [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081481


Locations
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United States, Florida
Vantage Health
Ocala, Florida, United States, 34474
United States, Maryland
Chesapeake Urology Associates
Baltimore, Maryland, United States, 21204
United States, New York
New York Urology Associates
New York, New York, United States, 10016
United States, Texas
Baylor Scott & White Memorial Hospital and Clinic
Temple, Texas, United States, 76508
United Kingdom
Princess Alexandra Hospital
Harlow, United Kingdom
Imperial College
London, United Kingdom
University College Hospital (UCLH)
London, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Sponsors and Collaborators
Sophiris Bio Corp
Investigators
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Principal Investigator: Hashim U Ahmed, MD Imperial College London
More Information
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Responsible Party: Sophiris Bio Corp
ClinicalTrials.gov Identifier: NCT03081481    
Other Study ID Numbers: PRX302-2-08
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sophiris Bio Corp:
Intraprostatic
MRI lesion
Prostate biopsies
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases