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Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Sophiris Bio Corp
Sponsor:
Information provided by (Responsible Party):
Sophiris Bio Corp
ClinicalTrials.gov Identifier:
NCT03081481
First received: March 7, 2017
Last updated: June 7, 2017
Last verified: June 2017
  Purpose
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 Intervention Phase
Prostate Cancer Drug: PRX302 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sophiris Bio Corp:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 40
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRX302
intraprostatic administration
Drug: PRX302
Single prostate cancer lesion injected with PRX302
Other Name: Topsalysin

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.
  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03081481

Contacts
Contact: Head of Operations 8582554711 clinicaloperations@sophiris.com

Locations
United States, Florida
South Florida Medical Research Recruiting
Fort Lauderdale, Florida, United States, 33180
Vantage Health Recruiting
Ocala, Florida, United States, 34474
United States, Texas
Baylor Scott & White Memorial Hospital and Clinic Recruiting
Temple, Texas, United States, 76508
United Kingdom
Imperial College Recruiting
London, United Kingdom
University Hospital Southampton Recruiting
Southampton, United Kingdom
Sponsors and Collaborators
Sophiris Bio Corp
Investigators
Principal Investigator: Hashim U Ahmed, MD Imperial College London
  More Information

Responsible Party: Sophiris Bio Corp
ClinicalTrials.gov Identifier: NCT03081481     History of Changes
Other Study ID Numbers: PRX302-2-08
Study First Received: March 7, 2017
Last Updated: June 7, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 19, 2017