Clinical trial NCT04017325: European Randomised Study of TOOKAD® Soluble for Prostate Cancer vs Active Surveillance. Post Study Follow-up
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. Post Study 5-year Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of the Prostate
Lead sponsor: Steba Biotech S.A.
Sponsor class: OTHER
Collaborators: name: International Drug Development Institute
name: ICON plc
First posted: 2019-07-12
Enrollment: 374
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with localized low risk prostate cancer initialy randomized in the study CLIN 1001 PCM301

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

Detailed description: This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). No intervention or further intervention with TOOKAD® Soluble is mandated in this additional 60-month follow-up study where patients in the original TOOKAD® Soluble group and active surveillance (control) group are both managed by their physician as appropriate to their condition using any treatment available following a 'local standard of care' principle from the end of the trial (M24) up to the end of follow-up (M84). Management decisions are entirely left to clinicians and their patients in this pragmatic extension of the trial (no criteria imposed) where standard of care that reflects clinical practice within each centre is applied.

All patients originally randomised in study CLIN1001 PCM301, whether allocated to the TOOKAD® Soluble VTP arm (n=206) or Active surveillance arm (n=207 and who did not withdraw their consent will be included in this extension study.

This extension study consists of 2 different follow-up:

* a follow-up of patients via investigators
* and a follow-up via interviews directly with patients

Eligibility criteria: Inclusion Criteria:

* 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):

  1. 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.
  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:

* As a reminder, all subjects originally randomized did not met the following criteria at entry (from the original protocol):

  1. Unwillingness to accept randomization 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. Subject in custody and or in residence in a nursing home or rehabilitation facility.
  8. 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).

Primary outcomes:
measure: Disease progression
timeFrame: Over the 5 years of follow up
measure: Other prostate cancer therapy
timeFrame: Over the 5 years of follow up
measure: Prostate cancer-related death.
timeFrame: Over the 5 years of follow up
Secondary outcomes:
measure: Absence of cancer
timeFrame: Over the 5 years of follow up
measure: Radical therapy
timeFrame: Over the 5 years of follow up
measure: Cancer burden
timeFrame: Over the 5 years of follow up
measure: Urinary incontinence
timeFrame: Over the 5 years of follow up
measure: Erectile dysfunction
timeFrame: Over the 5 years of follow up
measure: Urethral stenosis
timeFrame: Over the 5 years of follow up
measure: Prostate cancer complication
timeFrame: Over the 5 years of follow up
measure: Patients Questionnaires Quality of life
timeFrame: Over the 5 years of follow up
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Department of Urology-Tampere University Hospital-
city: Angers
country: France
facility: Centre Hospitalier Universitaire (CHU)
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: Lille
country: France
facility: Hôpital Claude Huriez
city: Marseille
country: France
facility: Hôpital La Conception
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: Pierre-Bénite
country: France
facility: Centre Hospitalier Universitaire Lyon Sud
city: Rennes
country: France
facility: CHU Pontchaillou
city: Saint Herblain
country: France
facility: Clinique Urologique Nantes
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: 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: Catharina Ziekenhuis
city: A Coruña
country: Spain
facility: Hospital Universitario de A Coruña
city: Barcelona
country: Spain
facility: Department of Urology-Hospital Clinic, University of Barcelona
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: London
country: United Kingdom
facility: Kings College Hospital (KCH)
city: London
country: United Kingdom
facility: University College London Hospital (UCLH)
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: