European Randomised Study of TOOKAD® Soluble for Prostate Cancer vs Active Surveillance. Post Study Follow-up

NCT04017325 | Completed

• 1 other identifier: CLIN1001 PCM301-FU5
• Study Type: observational
• Target: 374
• Locations: 8 countries
• Sites: 36

Brief Summary

This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). Additional 60-month follow-up study

Conditions

Cancer of the Prostate

Outcome Measures

Primary Outcomes (3)

• Disease progression

  Progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men initially randomized to TOOKAD® Soluble VTP compared to men originally randomized on active surveillance.

  Over the 5 years of follow up

• Other prostate cancer therapy

  Use of other prostate cancer therapy: radical therapy (surgery, radiotherapy, cryotherapy, ultrasound therapy), hormonal therapy or chemotherapy or any therapy indicated for the treatment of prostate cancer in the countries of the study.

  Over the 5 years of follow up

• Prostate cancer-related death.

  Any death related to Prostate cancer

  Over the 5 years of follow up

Secondary Outcomes (8)

• Absence of cancer

  Over the 5 years of follow up

• Radical therapy

  Over the 5 years of follow up

• Cancer burden

  Over the 5 years of follow up

• Urinary incontinence

  Over the 5 years of follow up

• Erectile dysfunction

  Over the 5 years of follow up

Study Arms (2)

TOOKAD VTP TREATMENT

Subjects randomized in the treatment arm (TOOKAD VTP treatment) in the initial period of the study.

Other: no intervention (post study follow up)

Active surveillance

Subjects randomized in the control group (active surveillance) in the initial period of the study.

Other: no intervention (post study follow up)

Interventions

no intervention (post study follow up) OTHER

No intervention (post study follow up)

Active surveillance; TOOKAD VTP TREATMENT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with localized low risk prostate cancer initialy randomized in the study CLIN 1001 PCM301

You may qualify if:

• All subjects originally randomized in study CLIN1001 PCM301 are included in this follow-up study. As a reminder, they all met the following criteria at entry (from the original protocol):
• Low risk prostate cancer diagnosed using one trans-rectal ultrasound guided biopsy (TRUS) using from 10 to 24 cores, within 12 months of enrolment and showing the following:
• Gleason 3 + 3 prostate adenocarcinoma as a maximum,
• Two (2) to three (3) cores positive for cancer. Patients with only one positive core can be included provided they have at least 3 mm of cancer core length.
• 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:

• As a reminder, all subjects originally randomized did not met the following criteria at entry (from the original protocol):
• Unwillingness to accept randomization 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 MRI (e.g., pacemaker, history of allergic reaction to gadolinium), or factors excluding accurate reading of pelvic MRI (e.g., hip prosthesis).

Sponsors & Collaborators

• Steba Biotech S.A.: lead
• International Drug Development Institute: collaborator
• ICON plc: collaborator

Study Sites (36)

Department of Urology-Tampere University Hospital-

Tampere, 33521, Finland

Location

Centre Hospitalier Universitaire (CHU)

Angers, France

Location

CHRU Hopital Jean Minjoz

Besançon, 25030, France

Location

Site Médipole

Cabestany, 66330, France

Location

Polyclinique Sévigné

Cesson-Sévigné, 35512, France

Location

Hôpital Claude Huriez

Lille, 59037, France

Location

Hôpital La Conception

Marseille, 13005, 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

CHU Pontchaillou

Rennes, 35 033, France

Location

Clinique Urologique Nantes

Saint-Herblain, 44800, 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

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

Torino, 10126, Italy

Location

Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Hospital Universitario de A Coruña

A Coruña, 15006, Spain

Location

Department of Urology-Hospital Clinic, University of Barcelona

Barcelona, 08036, 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

Kings College Hospital (KCH)

London, SE5 9RS, United Kingdom

Location

University College London Hospital (UCLH)

London, United Kingdom

Location

Oxford John Radcliffe Hospital Trust

Oxford, OX3 7LJ, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark EMBERTON, Professor

  University College of London Hospital , United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 12, 2019
• Study Start: March 17, 2016
• Primary Completion: June 3, 2020
• Study Completion: June 3, 2020
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); DE (11); SE (1); FR (12); GB (4); IT (1); FI (1); NL (2)