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

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310894
• Other study ID #: CLIN1001 PCM301
• Status: Completed
• Phase: Phase 3
• Start date: February 2011
• Est. completion date: August 2015

Study information

• Verified date: April 2016
• Source: Steba Biotech S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	Dept. of Urology-University Hospitals Leuven	Leuven
Finland	Department of Urology-Tampere University Hospital-	Tampere
France	Service d'Urologie - Centre Hospitalier Universitaire d'Angers	Angers
France	CHRU Hopital Jean Minjoz	Besançon
France	Site Médipole	Cabestany
France	Polyclinique Sévigné	Cesson Sévigné
France	Clinique d'Urologie et de Transplantation Rénale CHU Grenoble	Grenoble
France	Hôpital Claude Huriez	Lille
France	Hôpital La Conception	Marseille
France	Clinique Ambroise Paré	Neuilly sur Seine
France	Hôpital Tenon	Paris
France	Institut Mutualiste Montsouris (IMM)	Paris
France	Hôpital Cochin	Paris Cedex 14
France	Institut Mutualiste Montsouris (IMM)	Paris Cedex 14
France	Centre Hospitalier Universitaire Lyon Sud	Pierre-Bénite
France	Polyclinique les Bleuets	Reims
France	CHU Pontchaillou	Rennes
France	Clinique Urologique Nantes	Saint Herblain
France	Hôpital Foch	Suresnes
France	Centre Hospitalier Universitaire de Rangueil	Toulouse
Germany	Marien Krankenahaus GmbH	Bergisch Gladbach
Germany	ATURO-Gemeinschaftspraxis für Urologie und Andrologie	Berlin-Wilmersdorf
Germany	Klinikum Braunschweig	Braunschweig
Germany	Universitätsklinikum "Carl Gustav Carus" der Technischen Universität	Dresden
Germany	Urologische Gemeinschaftspraxis	Emmendingen
Germany	Martini-Klinik am UKE Hamburg-Eppendorf Prostate Cancer Center	Hamburg
Germany	Vinzenz Krankenhaus - Department of Urology	Hannover
Germany	SLK-Kliniken Heilbronn GmbH	Heilbronn
Germany	University Hospital Schleswig-Holstein	Kiel
Germany	Ludwig-Maximilians-Universität München	Munich
Germany	Urologie 24	Nuremberg
Italy	Unità Operativa Urologia Lucca - c/o Azienda USL 2 - Ospedale Campo di Marte	Lucca
Italy	Unità di Chirurgia Urologica Mininvasiva	Roma
Italy	Unità Operativa Urologica di Savona, Ospedale San Paolo di Savona	Savona
Italy	Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia	Torino
Netherlands	Netherlands Cancer Institute	Amsterdam
Netherlands	Polikliniek Urologie-Catharina Ziekenhuis	Eindhoven
Spain	Hospital Universitario de A Coruña	A Coruña
Spain	Department of Urology-Hospital Clinic, University of Barcelona	Barcelona
Spain	Fundacio Puigvert-Department of Urology	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Universitari de Bellbitge-Servico de Urologia	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital 12 de Octubre - Departmento de Urologia	Madrid
Spain	Complejo Hospitalario Regional Virgen Del Rocio-Department Urology	Sevilla
Spain	Instituto Valenciano de Oncologia	Valencia
Sweden	Dept of Urology-University Hospital-	Malmö
Switzerland	Anna-Seiler-Haus Inselspital	Bern
United Kingdom	Kings College Hospital (KCH)	London
United Kingdom	University College of London Hospital	London
United Kingdom	Oxford John Radcliffe Hospital Trust	Oxford
United Kingdom	Royal Hallamshire Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Steba Biotech S.A.

Countries where clinical trial is conducted

Belgium,  Finland,  France,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (1)

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, Emb — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Over 24 months follow-up
Secondary	Total number of cores positive for cancer	Total number of biopsy sample containing tumor cells at the month 24 biopsy	Month 24
Secondary	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.	Randomisation visit, Day 7 after VTP , Month 3, Month 6, Month 9, Month 12, Month 24
Secondary	The rate of adverse events	Number of patients experiencing adverse events divided by the total number of patients.	Screening-Month 24
Secondary	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.	Screening-Month 24
Secondary	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.	Randomisation visit; Month 12; Month 24