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Prostate CancerPhase 3PCM301NCT01310894

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

A Phase 3 study testing TOOKAD® Soluble in people with Prostate Cancer, run by Steba Biotech S.A. at 50 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
TOOKAD® Soluble
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
413 participants
Where
50 sitesin 10 countries
Study dates
Feb 2011to Aug 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects will be eligible for inclusion in the study if all of the following criteria are met:
  • 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.
  • Cancer clinical stage up to T2a (pathological or radiological up to T2c disease permitted)
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  • Serum prostate specific antigen (PSA) of 10 ng/mL or less
  • Prostate volume equal or greater than 25 cc and less than 70 cc.
  • Male subjects aged 18 years or older.

Who cannot join

  • Subjects will not be eligible for the study if meeting any of the following criteria:
  • Unwillingness to accept randomisation to either of the two arms of the study
  • Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy.
  • Any surgical intervention for benign prostatic hypertrophy
  • Life expectancy less than 10 years.
  • Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure.
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  • Participation in another clinical study or recipient of an investigational product within 1 month of study entry.
  • Subject unable to understand the patient's information document, to give consent or complete the study tasks.
  • Subject in custody and or in residence in a nursing home or rehabilitation facility
  • 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)
  • Any condition or history of illness or surgery that may pose an additional risk to men undergoing the TOOKAD® Soluble VTP procedure.

Trial locations and contacts

50 sites in 10 countries.

50 sites in 10 countries

France17 sites

  • Service d'Urologie - Centre Hospitalier Universitaire d'Angers

    Angers, 49933

  • CHRU Hopital Jean Minjoz

    Besançon, 25030

  • Site Médipole

    Cabestany, 66330

  • Polyclinique Sévigné

    Cesson-Sévigné, 35512

  • Clinique d'Urologie et de Transplantation Rénale CHU Grenoble

    Grenoble, 38043

  • Hôpital Claude Huriez

    Lille, 59037

  • Hôpital La Conception

    Marseille, 13005

  • Clinique Ambroise Paré

    Neuilly-sur-Seine, 92200

  • Hôpital Tenon

    Paris, 75020

  • Institut Mutualiste Montsouris (IMM)

    Paris, 75674

  • Hôpital Cochin

    Paris, 75679

  • Centre Hospitalier Universitaire Lyon Sud

    Pierre-Bénite, 69495

  • Polyclinique les Bleuets

    Reims, 51100

  • CHU Pontchaillou

    Rennes, 35 033

  • Clinique Urologique Nantes

    Saint-Herblain, 44800

  • Hôpital Foch

    Suresnes, 92150

  • Centre Hospitalier Universitaire de Rangueil

    Toulouse, 31403

Other trials in France

Germany11 sites

  • Marien Krankenahaus GmbH

    Bergisch Gladbach, 51465

  • ATURO-Gemeinschaftspraxis für Urologie und Andrologie

    Berlin-Wilmersdorf, D-14197

  • Klinikum Braunschweig

    Braunschweig, 38126

  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität

    Dresden, D-01307

  • Urologische Gemeinschaftspraxis

    Emmendingen, 79132

  • Martini-Klinik am UKE Hamburg-Eppendorf Prostate Cancer Center

    Hamburg, D-20246

  • Vinzenz Krankenhaus - Department of Urology

    Hanover, 30559

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078

  • University Hospital Schleswig-Holstein

    Kiel, D-24105

  • Ludwig-Maximilians-Universität München

    Munich, D - 81377

  • Urologie 24

    Nuremberg, 90491

Other trials in Germany

Spain8 sites

  • Hospital Universitario de A Coruña

    A Coruña, 15006

  • Fundacio Puigvert-Department of Urology

    Barcelona, 08025

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Department of Urology-Hospital Clinic, University of Barcelona

    Barcelona, 08036

  • Hospital Universitari de Bellbitge-Servico de Urologia

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital 12 de Octubre - Departmento de Urologia

    Madrid, 28041

  • Complejo Hospitalario Regional Virgen Del Rocio-Department Urology

    Seville, 41013

  • Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

Italy4 sites

  • Unità Operativa Urologia Lucca - c/o Azienda USL 2 - Ospedale Campo di Marte

    Lucca, 55100

  • Unità di Chirurgia Urologica Mininvasiva

    Roma, 00189

  • Unità Operativa Urologica di Savona, Ospedale San Paolo di Savona

    Savona, 17100

  • Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia

    Torino, 10126

Other trials in Italy

United Kingdom4 sites

  • Kings College Hospital (KCH)

    London, SE5 9RS

  • University College of London Hospital

    London

  • Oxford John Radcliffe Hospital Trust

    Oxford, OX3 7LJ

  • Royal Hallamshire Hospital

    Sheffield

Other trials in United Kingdom

Netherlands2 sites

  • Netherlands Cancer Institute

    Amsterdam, 1066 CX

  • Polikliniek Urologie-Catharina Ziekenhuis

    Eindhoven, 5623 EJ

Other trials in Netherlands

Belgium1 site

  • Dept. of Urology-University Hospitals Leuven

    Leuven, 3000

Other trials in Belgium

Finland1 site

  • Department of Urology-Tampere University Hospital-

    Tampere, 33521

Other trials in Finland

Sweden1 site

  • Dept of Urology-University Hospital-

    Malmö, 20502

Other trials in Sweden

Switzerland1 site

  • Anna-Seiler-Haus Inselspital

    Bern, CH-3010

Other trials in Switzerland

About this study

Official title: 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).
Read the 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.

Conditions
Prostate Cancer
Being tested
TOOKAD® Soluble
Keywords
Prostatic Disease, Genital Neoplasm,male, Urogenital neoplasm, Genital disease,male, Male urogenital disease, Neoplasms, Neoplasms by site, Prostatic neoplasm, Carcinoma
Medical subject headings
Prostatic Neoplasms, Prostatic Diseases, Genital Neoplasms, Male, Urogenital Neoplasms, Genital Diseases, Male, Male Urogenital Diseases, Neoplasms, Neoplasms by Site

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TOOKAD® SolubleDrug

    Also called WST11

    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

Study groups in NCT01310894
Study groupRoleWhat they receive
TOOKAD® SolubleExperimentalTOOKAD® Soluble, lyophilized formulation, given at a dose of 4mg/Kg.
Receives: Drug: TOOKAD® Soluble
Active SurveillanceNo interventionActive surveillance is one of the management strategy in men who have low-risk prostate cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Co-primary endpoint 'A': Rate of absence of definite cancer using patients on active surveillance as a comparison.

    Histological changes are assessed using biopsies or any other pathology result obtained during the study planned or not.

    Measured: Month 24

  2. 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.

    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

    Measured: Over 24 months follow-up.

Secondary outcomes (6)

  1. The rate of additional prostate cancer radical therapy

    Number of patients undergoing a radical treatment for prostate cancer such as: radical prostatectomy, radiotherapy, brachytherapy divided by the total number of patients.

    Measured: Over 24 months follow-up

  2. Total number of cores positive for cancer

    Total number of biopsy sample containing tumor cells at the month 24 biopsy

    Measured: Month 24

  3. The rate of incontinence, erectile dysfunction, urinary symptoms

    Number of patients experiencing urinary incontinence, erectile dysfunction or urinary symptoms events divided by the total number of patients.

    Measured: Randomisation visit, Day 7 after VTP , Month 3, Month 6, Month 9, Month 12, Month 24

  4. The rate of adverse events

    Number of patients experiencing adverse events divided by the total number of patients.

    Measured: Screening-Month 24

  5. The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death

    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.

    Measured: Screening-Month 24

  6. The overall quality of life will be recorded for potential utility and descriptive studies.

    Results of the International Index of Erectile Function (IIEF) and International Prostate Symptoms Score (IPSS) patients questionaires.

    Measured: Randomisation visit; Month 12; Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionJun 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
413 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01310894
Sponsor's protocol ID
CLIN1001 PCM301
Acronym
PCM301
Status last verified
Apr 2016
First submitted
1 Mar 2011
Last updated
11 Jul 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: The data are available in case report form for each patient

Publications

  • Azzouzi AR, Vincendeau S, Barret E, Cicco A, Kleinclauss F, van der Poel HG, Stief CG, Rassweiler J, Salomon G, Solsona E, Alcaraz A, Tammela TT, Rosario DJ, Gomez-Veiga F, Ahlgren G, Benzaghou F, Gaillac B, Amzal B, Debruyne FM, Fromont G, Gratzke C, Emberton M; PCM301 Study Group. Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase 3, randomised controlled trial. Lancet Oncol. 2017 Feb;18(2):181-191. doi: 10.1016/S1470-2045(16)30661-1. Epub 2016 Dec 20.

    PubMed 28007457

  • Azzouzi AR, Barret E, Bennet J, Moore C, Taneja S, Muir G, Villers A, Coleman J, Allen C, Scherz A, Emberton M. TOOKAD(R) Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer. World J Urol. 2015 Jul;33(7):945-53. doi: 10.1007/s00345-015-1505-8. Epub 2015 Feb 25.

    PubMed 25712310

  • Lebdai S, Villers A, Barret E, Nedelcu C, Bigot P, Azzouzi AR. Feasibility, safety, and efficacy of salvage radical prostatectomy after Tookad(R) Soluble focal treatment for localized prostate cancer. World J Urol. 2015 Jul;33(7):965-71. doi: 10.1007/s00345-015-1493-8. Epub 2015 Jan 23.

    PubMed 25614256

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TOOKAD® Soluble in people with Prostate Cancer, run by Steba Biotech S.A. at 50 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in France, Germany, Spain, Italy, United Kingdom and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Co-primary endpoint 'A': Rate of absence of definite cancer using patients on active surveillance as a comparison. (time frame: Month 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01310894, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.

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