Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance. (PCM301)

July 10, 2019 updated by: Steba Biotech S.A.

A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 3, multicentre, open label, randomised controlled study in subjects diagnosed with low risk prostate cancer on TransRectal Ultrasound (TRUS) guided biopsy.

Subjects will be randomised to either Active Surveillance or TOOKAD® Soluble VTP. Subjects will remain in the study for approximately 24 months following randomisation. A total of 400 subjects will be entered into the study; 200 will receive Active Surveillance and 200 will receive TOOKAD® Soluble-VTP.

Study Type

Interventional

Enrollment (Actual)

413

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Dept. of Urology-University Hospitals Leuven
  • Finland
      • Tampere, Finland, 33521
        • Department of Urology-Tampere University Hospital-
  • France
      • Angers, France, 49933
        • Service d'Urologie - Centre Hospitalier Universitaire d'Angers
      • Besançon, France, 25030
        • CHRU Hopital Jean Minjoz
      • Cabestany, France, 66330
        • Site Médipole
      • Cesson Sévigné, France, 35512
        • Polyclinique Sevigné
      • Grenoble, France, 38043
        • Clinique d'Urologie et de Transplantation Rénale CHU Grenoble
      • Lille, France, 59037
        • Hôpital Claude Huriez
      • Marseille, France, 13005
        • Hopital La Conception
      • Neuilly sur Seine, France, 92200
        • Clinique Ambroise Paré
      • Paris, France, 75020
        • Hôpital Tenon
      • Paris, France, 75674
        • Institut Mutualiste Montsouris (IMM)
      • Paris Cedex 14, France, 75674
        • Institut Mutualiste Montsouris (IMM)
      • Paris Cedex 14, France, 75679
        • Hôpital COCHIN
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Universitaire Lyon Sud
      • Reims, France, 51100
        • Polyclinique Les Bleuets
      • Rennes, France, 35 033
        • CHU Pontchaillou
      • Saint Herblain, France, 44800
        • Clinique Urologique Nantes
      • Suresnes, France, 92150
        • Hopital FOCH
      • Toulouse, France, 31403
        • Centre Hospitalier Universitaire de Rangueil
  • Germany
      • Bergisch Gladbach, Germany, 51465
        • Marien Krankenahaus GmbH
      • Berlin-Wilmersdorf, Germany, D-14197
        • ATURO-Gemeinschaftspraxis für Urologie und Andrologie
      • Braunschweig, Germany, 38126
        • Klinikum Braunschweig
      • Dresden, Germany, D-01307
        • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität
      • Emmendingen, Germany, 79132
        • Urologische Gemeinschaftspraxis
      • Hamburg, Germany, D-20246
        • Martini-Klinik am UKE Hamburg-Eppendorf Prostate Cancer Center
      • Hannover, Germany, 30559
        • Vinzenz Krankenhaus - Department of Urology
      • Heilbronn, Germany, 74078
        • SLK-Kliniken Heilbronn GmbH
      • Kiel, Germany, D-24105
        • University Hospital Schleswig-Holstein
      • Munich, Germany, D - 81377
        • Ludwig-Maximilians-Universität München
      • Nuremberg, Germany, 90491
        • Urologie 24
  • Italy
      • Lucca, Italy, 55100
        • Unità Operativa Urologia Lucca - c/o Azienda USL 2 - Ospedale Campo di Marte
      • Roma, Italy, 00189
        • Unità di Chirurgia Urologica Mininvasiva
      • Savona, Italy, 17100
        • Unità Operativa Urologica di Savona, Ospedale San Paolo di Savona
      • Torino, Italy, 10126
        • Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Netherlands Cancer Institute
      • Eindhoven, Netherlands, 5623 EJ
        • Polikliniek Urologie-Catharina Ziekenhuis
  • Spain
      • A Coruña, Spain, 15006
        • Hospital Universitario de A Coruna
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08025
        • Fundacio Puigvert-Department of Urology
      • Barcelona, Spain, 08036
        • Department of Urology-Hospital Clinic, University of Barcelona
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre - Departmento de Urologia
      • Sevilla, Spain, 41013
        • Complejo Hospitalario Regional Virgen Del Rocio-Department Urology
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncología
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellbitge-Servico de Urologia
  • Sweden
      • Malmö, Sweden, 20502
        • Dept of Urology-University Hospital-
  • Switzerland
      • Bern, Switzerland, CH-3010
        • Anna-Seiler-Haus Inselspital
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital (KCH)
      • London, United Kingdom
        • University College of London Hospital
      • Oxford, United Kingdom, OX3 7LJ
        • Oxford John Radcliffe Hospital Trust
      • Sheffield, United Kingdom
        • Royal Hallamshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Subjects will be eligible for inclusion in the study if all of the following criteria are met:

  1. Low risk prostate cancer diagnosed using one transrectal ultrasound guided biopsy (TRUS)using from 10 to 24 cores performed less than 12 months prior to enrolment, and showing the following:

    • Gleason 3 + 3 prostate adenocarcinoma as a maximum,
    • Two (2) to three (3) cores positive for cancer
    • A maximum cancer core length of 5 mm in any core.
  2. Cancer clinical stage up to T2a (pathological or radiological up to T2c disease permitted)
  3. Serum prostate specific antigen (PSA) of 10 ng/mL or less
  4. Prostate volume equal or greater than 25 cc and less than 70 cc.
  5. Male subjects aged 18 years or older.

Exclusion Criteria:

Subjects will not be eligible for the study if meeting any of the following criteria:

  1. Unwillingness to accept randomisation to either of the two arms of the study
  2. Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy.
  3. Any surgical intervention for benign prostatic hypertrophy
  4. Life expectancy less than 10 years.
  5. Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure.
  6. Participation in another clinical study or recipient of an investigational product within 1 month of study entry.
  7. Subject unable to understand the patient's information document, to give consent or complete the study tasks.
  8. Subject in custody and or in residence in a nursing home or rehabilitation facility
  9. Contra-indication to Magnetic resonance Imaging (MRI) (e.g., pacemaker, history of allergic reaction to gadolinium), or factors excluding accurate reading of pelvic MRI (e.g., hip prosthesis)
  10. Any condition or history of illness or surgery that may pose an additional risk to men undergoing the TOOKAD® Soluble VTP procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TOOKAD® Soluble
TOOKAD® Soluble, lyophilized formulation, given at a dose of 4mg/Kg.
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
Other Names:
  • WST11
No Intervention: Active Surveillance
Active surveillance is one of the management strategy in men who have low-risk prostate cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Co-primary endpoint 'A': Rate of absence of definite cancer using patients on active surveillance as a comparison.
Time Frame: Month 24
Histological changes are assessed using biopsies or any other pathology result obtained during the study planned or not.
Month 24
Co-primary endpoint 'B': Difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer.
Time Frame: Over 24 months follow-up.

Moderate or higher risk is defined as the observation of:

  • More than 3 cores positive for cancer when considering all histological examination available during follow-up of study;
  • or any Gleason primary or secondary pattern 4 or more;
  • or at least one cancer core length greater than 5 mm;
  • or PSA>10ng/mL ( in 3 consecutive measures);
  • or any T3 prostate cancer,
  • or metastasis;
  • or prostate cancer related death
Over 24 months follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of additional prostate cancer radical therapy
Time Frame: Over 24 months follow-up
Number of patients undergoing a radical treatment for prostate cancer such as: radical prostatectomy, radiotherapy, brachytherapy divided by the total number of patients.
Over 24 months follow-up
Total number of cores positive for cancer
Time Frame: Month 24
Total number of biopsy sample containing tumor cells at the month 24 biopsy
Month 24
The rate of incontinence, erectile dysfunction, urinary symptoms
Time Frame: Randomisation visit, Day 7 after VTP , Month 3, Month 6, Month 9, Month 12, Month 24
Number of patients experiencing urinary incontinence, erectile dysfunction or urinary symptoms events divided by the total number of patients.
Randomisation visit, Day 7 after VTP , Month 3, Month 6, Month 9, Month 12, Month 24
The rate of adverse events
Time Frame: Screening-Month 24
Number of patients experiencing adverse events divided by the total number of patients.
Screening-Month 24
The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death
Time Frame: Screening-Month 24
Number of patients experiencing severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death divided by the total number of patients.
Screening-Month 24
The overall quality of life will be recorded for potential utility and descriptive studies.
Time Frame: Randomisation visit; Month 12; Month 24
Results of the International Index of Erectile Function (IIEF) and International Prostate Symptoms Score (IPSS) patients questionaires.
Randomisation visit; Month 12; Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steba Biotech S.A.

Investigators

  • Principal Investigator: Mark EMBERTON, Professor, University College of London Hospital , United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 1, 2011

First Submitted That Met QC Criteria

March 5, 2011

First Posted (Estimate)

March 9, 2011

Study Record Updates

Last Update Posted (Actual)

July 11, 2019

Last Update Submitted That Met QC Criteria

July 10, 2019

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN1001 PCM301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data are available in case report form for each patient

IPD Sharing Time Frame

Data available on request.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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