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

NCT01310894 | Completed Phase 3 DMC

• 1 other identifier: CLIN1001 PCM301
• Study Type: interventional
• Target: 413
• Locations: 10 countries
• Sites: 50

Brief 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

Prostate Cancer

Keywords

Prostatic Disease; Genital Neoplasm,male; Urogenital neoplasm; Genital disease,male; Male urogenital disease; Neoplasms; Neoplasms by site; Prostatic neoplasm; Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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 Outcomes (6)

• The rate of additional prostate cancer radical therapy

  Over 24 months follow-up

• Total number of cores positive for cancer

  Month 24

• The rate of incontinence, erectile dysfunction, urinary symptoms

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

• The rate of adverse events

  Screening-Month 24

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

  Screening-Month 24

Study Arms (2)

TOOKAD® Soluble

EXPERIMENTAL

TOOKAD® Soluble, lyophilized formulation, given at a dose of 4mg/Kg.

Drug: TOOKAD® Soluble

Active Surveillance

NO INTERVENTION

Active surveillance is one of the management strategy in men who have low-risk prostate cancer

Interventions

TOOKAD® Soluble DRUG

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

Also known as: WST11

TOOKAD® Soluble

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Steba Biotech S.A.: lead

Study Sites (50)

Dept. of Urology-University Hospitals Leuven

Leuven, 3000, Belgium

Location

Department of Urology-Tampere University Hospital-

Tampere, 33521, Finland

Location

Service d'Urologie - Centre Hospitalier Universitaire d'Angers

Angers, 49933, France

Location

CHRU Hopital Jean Minjoz

Besançon, 25030, France

Location

Site Médipole

Cabestany, 66330, France

Location

Polyclinique Sévigné

Cesson-Sévigné, 35512, France

Location

Clinique d'Urologie et de Transplantation Rénale CHU Grenoble

Grenoble, 38043, France

Location

Hôpital Claude Huriez

Lille, 59037, France

Location

Hôpital La Conception

Marseille, 13005, France

Location

Clinique Ambroise Paré

Neuilly-sur-Seine, 92200, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Institut Mutualiste Montsouris (IMM)

Paris, 75674, France

Location

Hôpital Cochin

Paris, 75679, France

Location

Centre Hospitalier Universitaire Lyon Sud

Pierre-Bénite, 69495, France

Location

Polyclinique les Bleuets

Reims, 51100, France

Location

CHU Pontchaillou

Rennes, 35 033, France

Location

Clinique Urologique Nantes

Saint-Herblain, 44800, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Centre Hospitalier Universitaire de Rangueil

Toulouse, 31403, France

Location

Marien Krankenahaus GmbH

Bergisch Gladbach, 51465, Germany

Location

ATURO-Gemeinschaftspraxis für Urologie und Andrologie

Berlin-Wilmersdorf, D-14197, Germany

Location

Klinikum Braunschweig

Braunschweig, 38126, Germany

Location

Universitätsklinikum "Carl Gustav Carus" der Technischen Universität

Dresden, D-01307, Germany

Location

Urologische Gemeinschaftspraxis

Emmendingen, 79132, Germany

Location

Martini-Klinik am UKE Hamburg-Eppendorf Prostate Cancer Center

Hamburg, D-20246, Germany

Location

Vinzenz Krankenhaus - Department of Urology

Hanover, 30559, Germany

Location

SLK-Kliniken Heilbronn GmbH

Heilbronn, 74078, Germany

Location

University Hospital Schleswig-Holstein

Kiel, D-24105, Germany

Location

Ludwig-Maximilians-Universität München

Munich, D - 81377, Germany

Location

Urologie 24

Nuremberg, 90491, Germany

Location

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

Lucca, 55100, Italy

Location

Unità di Chirurgia Urologica Mininvasiva

Roma, 00189, Italy

Location

Unità Operativa Urologica di Savona, Ospedale San Paolo di Savona

Savona, 17100, Italy

Location

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

Torino, 10126, Italy

Location

Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

Polikliniek Urologie-Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Hospital Universitari de Bellbitge-Servico de Urologia

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario de A Coruña

A Coruña, 15006, Spain

Location

Fundacio Puigvert-Department of Urology

Barcelona, 08025, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Department of Urology-Hospital Clinic, University of Barcelona

Barcelona, 08036, Spain

Location

Hospital 12 de Octubre - Departmento de Urologia

Madrid, 28041, Spain

Location

Complejo Hospitalario Regional Virgen Del Rocio-Department Urology

Seville, 41013, Spain

Location

Instituto Valenciano de Oncologia

Valencia, 46009, Spain

Location

Dept of Urology-University Hospital-

Malmo, 20502, Sweden

Location

Anna-Seiler-Haus Inselspital

Bern, CH-3010, Switzerland

Location

Kings College Hospital (KCH)

London, SE5 9RS, United Kingdom

Location

University College of London Hospital

London, United Kingdom

Location

Oxford John Radcliffe Hospital Trust

Oxford, OX3 7LJ, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 28007457 RESULT

• 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.

  PMID: 25712310 DERIVED

• 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.

  PMID: 25614256 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Male Urogenital Diseases; Neoplasms; Neoplasms by Site; Carcinoma

Interventions

padeliporfin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Mark Emberton, Professor

  University College of London Hospital , United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: March 9, 2011
• Study Start: February 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 11, 2019

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data available on request.

Locations

ES (8); BE (1); GB (4); SE (1); IT (4); FI (1); CH (1); DE (11); FR (17); NL (2)