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Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.

NCT01310894 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2019-07-11

No results posted yet for this study

Summary

The aims of this study are:

* to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and
* to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B).

Conditions

Interventions

DRUG

TOOKAD® Soluble

TOOKAD® Soluble-VTP procedure will consist of an IntraVenous (IV) administration to patients using a 753nm laser light at a fixed power of 150mW/cm and a fixed energy at 200J/cm delivered through transperineal interstitial optical fibers. The needles are positioned in the prostate under ultra sound image guidance

Sponsors & Collaborators

  • Steba Biotech S.A.

    lead OTHER

Principal Investigators

  • Mark Emberton, Professor · University College of London Hospital , United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2015-06-30
Completion
2015-08-31

Countries

  • Belgium
  • Finland
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01310894 on ClinicalTrials.gov