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

Cancer of the Prostate Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04017325
• Other study ID #: CLIN1001 PCM301-FU5
• Status: Completed
• Start date: March 17, 2016
• Est. completion date: June 3, 2020

Study information

• Verified date: March 2021
• Source: Steba Biotech S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: June 3, 2020
• Est. primary completion date: June 3, 2020
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer of the Prostate
• Prostatic Neoplasms

Intervention

Other:
• no intervention (post study follow up)
No intervention (post study follow up)

Locations

Country	Name	City	State
Finland	Department of Urology-Tampere University Hospital-	Tampere
France	Centre Hospitalier Universitaire (CHU)	Angers
France	CHRU Hopital Jean Minjoz	Besançon
France	Site Médipole	Cabestany
France	Polyclinique Sévigné	Cesson Sévigné
France	Hôpital Claude Huriez	Lille
France	Hôpital La Conception	Marseille
France	Hôpital Tenon	Paris
France	Hôpital Cochin	Paris Cedex 14
France	Institut Mutualiste Montsouris (IMM)	Paris Cedex 14
France	Centre Hospitalier Universitaire Lyon Sud	Pierre-Bénite
France	CHU Pontchaillou	Rennes
France	Clinique Urologique Nantes	Saint Herblain
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	Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia	Torino
Netherlands	Netherlands Cancer Institute	Amsterdam
Netherlands	Catharina Ziekenhuis	Eindhoven
Spain	Hospital Universitario de A Coruña	A Coruña
Spain	Department of Urology-Hospital Clinic, University of Barcelona	Barcelona
Spain	Complejo Hospitalario Regional Virgen Del Rocio-Department Urology	Sevilla
Spain	Instituto Valenciano de Oncologia	Valencia
Sweden	Dept of Urology-University Hospital-	Malmö
United Kingdom	Kings College Hospital (KCH)	London
United Kingdom	University College London Hospital (UCLH)	London
United Kingdom	Oxford John Radcliffe Hospital Trust	Oxford
United Kingdom	Royal Hallamshire Hospital	Sheffield

Sponsors (3)

Lead Sponsor	Collaborator
Steba Biotech S.A.	ICON plc, International Drug Development Institute

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Prostate cancer-related death.	Any death related to Prostate cancer	Over the 5 years of follow up
Secondary	Absence of cancer	The proportion of absence of cancer at biopsy (when available)	Over the 5 years of follow up
Secondary	Radical therapy	The rate of prostate cancer radical therapy;	Over the 5 years of follow up
Secondary	Cancer burden	The total cancer burden in the prostate	Over the 5 years of follow up
Secondary	Urinary incontinence	The description of incontinence in terms of mean, median, SD, inter-quartile ranges, min-max	Over the 5 years of follow up
Secondary	Erectile dysfunction	The description of erectile dysfunction in terms of mean, median, SD, inter-quartile ranges, min-max	Over the 5 years of follow up
Secondary	Urethral stenosis	The rate of urethral stenosis	Over the 5 years of follow up
Secondary	Prostate cancer complication	The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death	Over the 5 years of follow up
Secondary	Patients Questionnaires Quality of life	Overal Quality of Life will be recorded for potential utility and descriptives studies	Over the 5 years of follow up