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Evaluate, Safety and Tolerability of Intraprostatic PRX302 Administration, Low to Intermediate Risk 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: NCT02499848
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Sophiris Bio Corp

Study Description
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Brief Summary:
To Evaluate Safety, Tolerability and Potential Efficacy of PRX302 effect on clinically significant localised low to intermediate prostate cancer.

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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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: Intraprostatic administration
PRX302
 Drug: PRX302
Single prostate cancer lesion injected with PRX302.
Other Name: Topsalysin


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Eligibility Criteria
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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:

  • 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).
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): NCT02499848


Locations
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United Kingdom
UCLH
London, United Kingdom
Sponsors and Collaborators
Sophiris Bio Corp
Investigators
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Principal Investigator: Hashim U Ahmed, PhD,FRCS Division of Surgery & Interventional Science University College London
More Information
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Responsible Party: Sophiris Bio Corp
ClinicalTrials.gov Identifier: NCT02499848    
Other Study ID Numbers: PRX302-2-07
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Keywords provided by Sophiris Bio Corp:
MRI Lesion
transperineal injection
prostate biopsies
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases