Clinical trial NCT01310894: Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostatic Disease
Genital Neoplasm,male
Urogenital neoplasm
Genital disease,male
Male urogenital disease
Neoplasms
Neoplasms by site
Prostatic neoplasm
Carcinoma
Lead sponsor: Steba Biotech S.A.
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 413
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Co-primary endpoint 'A': Rate of absence of definite cancer using patients on active surveillance as a comparison.
timeFrame: Month 24
measure: 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.
timeFrame: Over 24 months follow-up.
Secondary outcomes:
measure: The rate of additional prostate cancer radical therapy
timeFrame: Over 24 months follow-up
measure: Total number of cores positive for cancer
timeFrame: Month 24
measure: The rate of incontinence, erectile dysfunction, urinary symptoms
timeFrame: Randomisation visit, Day 7 after VTP , Month 3, Month 6, Month 9, Month 12, Month 24
measure: The rate of adverse events
timeFrame: Screening-Month 24
measure: The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death
timeFrame: Screening-Month 24
measure: The overall quality of life will be recorded for potential utility and descriptive studies.
timeFrame: Randomisation visit; Month 12; Month 24
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Dept. of Urology-University Hospitals Leuven
city: Tampere
country: Finland
facility: Department of Urology-Tampere University Hospital-
city: Angers
country: France
facility: Service d'Urologie - Centre Hospitalier Universitaire d'Angers
city: Besançon
country: France
facility: CHRU Hopital Jean Minjoz
city: Cabestany
country: France
facility: Site Médipole
city: Cesson Sévigné
country: France
facility: Polyclinique Sévigné
city: Grenoble
country: France
facility: Clinique d'Urologie et de Transplantation Rénale CHU Grenoble
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Marseille
country: France
facility: Hôpital La Conception
city: Neuilly sur Seine
country: France
facility: Clinique Ambroise Paré
city: Paris Cedex 14
country: France
facility: Institut Mutualiste Montsouris (IMM)
city: Paris Cedex 14
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Institut Mutualiste Montsouris (IMM)
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Universitaire Lyon Sud
city: Reims
country: France
facility: Polyclinique les Bleuets
city: Rennes
country: France
facility: CHU Pontchaillou
city: Saint Herblain
country: France
facility: Clinique Urologique Nantes
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Rangueil
city: Bergisch Gladbach
country: Germany
facility: Marien Krankenahaus GmbH
city: Berlin-Wilmersdorf
country: Germany
facility: ATURO-Gemeinschaftspraxis für Urologie und Andrologie
city: Braunschweig
country: Germany
facility: Klinikum Braunschweig
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität
city: Emmendingen
country: Germany
facility: Urologische Gemeinschaftspraxis
city: Hamburg
country: Germany
facility: Martini-Klinik am UKE Hamburg-Eppendorf Prostate Cancer Center
city: Hannover
country: Germany
facility: Vinzenz Krankenhaus - Department of Urology
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn GmbH
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein
city: Munich
country: Germany
facility: Ludwig-Maximilians-Universität München
city: Nuremberg
country: Germany
facility: Urologie 24
city: Lucca
country: Italy
facility: Unità Operativa Urologia Lucca - c/o Azienda USL 2 - Ospedale Campo di Marte
city: Roma
country: Italy
facility: Unità di Chirurgia Urologica Mininvasiva
city: Savona
country: Italy
facility: Unità Operativa Urologica di Savona, Ospedale San Paolo di Savona
city: Torino
country: Italy
facility: Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
city: Eindhoven
country: Netherlands
facility: Polikliniek Urologie-Catharina Ziekenhuis
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellbitge-Servico de Urologia
state: Barcelona
city: A Coruña
country: Spain
facility: Hospital Universitario de A Coruña
city: Barcelona
country: Spain
facility: Fundacio Puigvert-Department of Urology
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Department of Urology-Hospital Clinic, University of Barcelona
city: Madrid
country: Spain
facility: Hospital 12 de Octubre - Departmento de Urologia
city: Sevilla
country: Spain
facility: Complejo Hospitalario Regional Virgen Del Rocio-Department Urology
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia
city: Malmö
country: Sweden
facility: Dept of Urology-University Hospital-
city: Bern
country: Switzerland
facility: Anna-Seiler-Haus Inselspital
city: London
country: United Kingdom
facility: Kings College Hospital (KCH)
city: London
country: United Kingdom
facility: University College of London Hospital
city: Oxford
country: United Kingdom
facility: Oxford John Radcliffe Hospital Trust
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
Study officials:
affiliation: University College of London Hospital , United Kingdom
name: Mark Emberton, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.