Back to resultsEfficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance. (PCM301)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TOOKAD® Soluble
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostatic Disease, Genital Neoplasm,male, Urogenital neoplasm, Genital disease,male, Male urogenital disease, Neoplasms, Neoplasms by site, Prostatic neoplasm, Carcinoma
Eligibility Criteria
Inclusion Criteria:
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)
- 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.
Exclusion Criteria:
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.
Sites / Locations
- Dept. of Urology-University Hospitals Leuven
- Department of Urology-Tampere University Hospital-
- Service d'Urologie - Centre Hospitalier Universitaire d'Angers
- CHRU Hopital Jean Minjoz
- Site Médipole
- Polyclinique Sévigné
- Clinique d'Urologie et de Transplantation Rénale CHU Grenoble
- Hôpital Claude Huriez
- Hôpital La Conception
- Clinique Ambroise Paré
- Institut Mutualiste Montsouris (IMM)
- Hôpital Cochin
- Hôpital Tenon
- Institut Mutualiste Montsouris (IMM)
- Centre Hospitalier Universitaire Lyon Sud
- Polyclinique les Bleuets
- CHU Pontchaillou
- Clinique Urologique Nantes
- Hôpital Foch
- Centre Hospitalier Universitaire de Rangueil
- Marien Krankenahaus GmbH
- ATURO-Gemeinschaftspraxis für Urologie und Andrologie
- Klinikum Braunschweig
- Universitätsklinikum "Carl Gustav Carus" der Technischen Universität
- Urologische Gemeinschaftspraxis
- Martini-Klinik am UKE Hamburg-Eppendorf Prostate Cancer Center
- Vinzenz Krankenhaus - Department of Urology
- SLK-Kliniken Heilbronn GmbH
- University Hospital Schleswig-Holstein
- Ludwig-Maximilians-Universität München
- Urologie 24
- Unità Operativa Urologia Lucca - c/o Azienda USL 2 - Ospedale Campo di Marte
- Unità di Chirurgia Urologica Mininvasiva
- Unità Operativa Urologica di Savona, Ospedale San Paolo di Savona
- Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia
- Netherlands Cancer Institute
- Polikliniek Urologie-Catharina Ziekenhuis
- Hospital Universitari de Bellbitge-Servico de Urologia
- Hospital Universitario de A Coruña
- Fundacio Puigvert-Department of Urology
- Hospital Vall d'Hebron
- Department of Urology-Hospital Clinic, University of Barcelona
- Hospital 12 de Octubre - Departmento de Urologia
- Complejo Hospitalario Regional Virgen Del Rocio-Department Urology
- Instituto Valenciano de Oncologia
- Dept of Urology-University Hospital-
- Anna-Seiler-Haus Inselspital
- Kings College Hospital (KCH)
- University College of London Hospital
- Oxford John Radcliffe Hospital Trust
- Royal Hallamshire Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TOOKAD® Soluble
Active Surveillance
Arm Description
TOOKAD® Soluble, lyophilized formulation, given at a dose of 4mg/Kg.
Active surveillance is one of the management strategy in men who have low-risk prostate cancer
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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.
Total number of cores positive for cancer
Total number of biopsy sample containing tumor cells at the month 24 biopsy
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.
The rate of adverse events
Number of patients experiencing adverse events divided by the total number of patients.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01310894
Brief Title
Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.
Acronym
PCM301
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
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Steba Biotech S.A.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostatic Disease, Genital Neoplasm,male, Urogenital neoplasm, Genital disease,male, Male urogenital disease, Neoplasms, Neoplasms by site, Prostatic neoplasm, Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
413 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TOOKAD® Soluble
Arm Type
Experimental
Arm Description
TOOKAD® Soluble, lyophilized formulation, given at a dose of 4mg/Kg.
Arm Title
Active Surveillance
Arm Type
No Intervention
Arm Description
Active surveillance is one of the management strategy in men who have low-risk prostate cancer
Intervention Type
Drug
Intervention Name(s)
TOOKAD® Soluble
Other Intervention Name(s)
WST11
Intervention Description
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
Primary Outcome Measure Information:
Title
Co-primary endpoint 'A': Rate of absence of definite cancer using patients on active surveillance as a comparison.
Description
Histological changes are assessed using biopsies or any other pathology result obtained during the study planned or not.
Time Frame
Month 24
Title
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.
Description
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
Time Frame
Over 24 months follow-up.
Secondary Outcome Measure Information:
Title
The rate of additional prostate cancer radical therapy
Description
Number of patients undergoing a radical treatment for prostate cancer such as: radical prostatectomy, radiotherapy, brachytherapy divided by the total number of patients.
Time Frame
Over 24 months follow-up
Title
Total number of cores positive for cancer
Description
Total number of biopsy sample containing tumor cells at the month 24 biopsy
Time Frame
Month 24
Title
The rate of incontinence, erectile dysfunction, urinary symptoms
Description
Number of patients experiencing urinary incontinence, erectile dysfunction or urinary symptoms events divided by the total number of patients.
Time Frame
Randomisation visit, Day 7 after VTP , Month 3, Month 6, Month 9, Month 12, Month 24
Title
The rate of adverse events
Description
Number of patients experiencing adverse events divided by the total number of patients.
Time Frame
Screening-Month 24
Title
The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death
Description
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.
Time Frame
Screening-Month 24
Title
The overall quality of life will be recorded for potential utility and descriptive studies.
Description
Results of the International Index of Erectile Function (IIEF) and International Prostate Symptoms Score (IPSS) patients questionaires.
Time Frame
Randomisation visit; Month 12; Month 24
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Emberton, Professor
Organizational Affiliation
University College of London Hospital , United Kingdom
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Urology-University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Department of Urology-Tampere University Hospital-
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Service d'Urologie - Centre Hospitalier Universitaire d'Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
CHRU Hopital Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Site Médipole
City
Cabestany
ZIP/Postal Code
66330
Country
France
Facility Name
Polyclinique Sévigné
City
Cesson Sévigné
ZIP/Postal Code
35512
Country
France
Facility Name
Clinique d'Urologie et de Transplantation Rénale CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital La Conception
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Clinique Ambroise Paré
City
Neuilly sur Seine
ZIP/Postal Code
92200
Country
France
Facility Name
Institut Mutualiste Montsouris (IMM)
City
Paris Cedex 14
ZIP/Postal Code
75674
Country
France
Facility Name
Hôpital Cochin
City
Paris Cedex 14
ZIP/Postal Code
75679
Country
France
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Institut Mutualiste Montsouris (IMM)
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Centre Hospitalier Universitaire Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Polyclinique les Bleuets
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
CHU Pontchaillou
City
Rennes
ZIP/Postal Code
35 033
Country
France
Facility Name
Clinique Urologique Nantes
City
Saint Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Facility Name
Centre Hospitalier Universitaire de Rangueil
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
Marien Krankenahaus GmbH
City
Bergisch Gladbach
ZIP/Postal Code
51465
Country
Germany
Facility Name
ATURO-Gemeinschaftspraxis für Urologie und Andrologie
City
Berlin-Wilmersdorf
ZIP/Postal Code
D-14197
Country
Germany
Facility Name
Klinikum Braunschweig
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany
Facility Name
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
Urologische Gemeinschaftspraxis
City
Emmendingen
ZIP/Postal Code
79132
Country
Germany
Facility Name
Martini-Klinik am UKE Hamburg-Eppendorf Prostate Cancer Center
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Vinzenz Krankenhaus - Department of Urology
City
Hannover
ZIP/Postal Code
30559
Country
Germany
Facility Name
SLK-Kliniken Heilbronn GmbH
City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
Facility Name
University Hospital Schleswig-Holstein
City
Kiel
ZIP/Postal Code
D-24105
Country
Germany
Facility Name
Ludwig-Maximilians-Universität München
City
Munich
ZIP/Postal Code
D - 81377
Country
Germany
Facility Name
Urologie 24
City
Nuremberg
ZIP/Postal Code
90491
Country
Germany
Facility Name
Unità Operativa Urologia Lucca - c/o Azienda USL 2 - Ospedale Campo di Marte
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Facility Name
Unità di Chirurgia Urologica Mininvasiva
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Unità Operativa Urologica di Savona, Ospedale San Paolo di Savona
City
Savona
ZIP/Postal Code
17100
Country
Italy
Facility Name
Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Netherlands Cancer Institute
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Polikliniek Urologie-Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Hospital Universitari de Bellbitge-Servico de Urologia
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario de A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Fundacio Puigvert-Department of Urology
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Department of Urology-Hospital Clinic, University of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital 12 de Octubre - Departmento de Urologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Complejo Hospitalario Regional Virgen Del Rocio-Department Urology
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Dept of Urology-University Hospital-
City
Malmö
ZIP/Postal Code
20502
Country
Sweden
Facility Name
Anna-Seiler-Haus Inselspital
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Kings College Hospital (KCH)
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
University College of London Hospital
City
London
Country
United Kingdom
Facility Name
Oxford John Radcliffe Hospital Trust
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data are available in case report form for each patient
IPD Sharing Time Frame
Data available on request.
Citations:
PubMed Identifier
28007457
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.
Results Reference
result
PubMed Identifier
25712310
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.
Results Reference
derived
PubMed Identifier
25614256
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.
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