Cancer of the ProstateNCT04017325
European Randomised Study of TOOKAD® Soluble for Prostate Cancer vs Active Surveillance. Post Study Follow-up
An observational study of Cancer of the Prostate, run by Steba Biotech S.A. at 36 sites in 8 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer of the Prostate
- How many people
- 374 participants
- Where
- 36 sitesin 8 countries
- Study dates
- 17 Mar 2016to 3 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
Study population: Patients with localized low risk prostate cancer initialy randomized in the study CLIN 1001 PCM301
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
36 sites in 8 countries.
36 sites in 8 countries
France12 sites
Centre Hospitalier Universitaire (CHU)
Angers
CHRU Hopital Jean Minjoz
Besançon, 25030
Site Médipole
Cabestany, 66330
Polyclinique Sévigné
Cesson-Sévigné, 35512
Hôpital Claude Huriez
Lille, 59037
Hôpital La Conception
Marseille, 13005
Hôpital Tenon
Paris, 75020
Institut Mutualiste Montsouris (IMM)
Paris, 75674
Hôpital Cochin
Paris, 75679
Centre Hospitalier Universitaire Lyon Sud
Pierre-Bénite, 69495
CHU Pontchaillou
Rennes, 35 033
Clinique Urologique Nantes
Saint-Herblain, 44800
Germany11 sites
Marien Krankenahaus GmbH
Bergisch Gladbach, 51465
ATURO-Gemeinschaftspraxis für Urologie und Andrologie
Berlin-Wilmersdorf, D-14197
Klinikum Braunschweig
Braunschweig, 38126
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität
Dresden, D-01307
Urologische Gemeinschaftspraxis
Emmendingen, 79132
Martini-Klinik am UKE Hamburg-Eppendorf Prostate Cancer Center
Hamburg, D-20246
Vinzenz Krankenhaus - Department of Urology
Hanover, 30559
SLK-Kliniken Heilbronn GmbH
Heilbronn, 74078
University Hospital Schleswig-Holstein
Kiel, D-24105
Ludwig-Maximilians-Universität München
Munich, D - 81377
Urologie 24
Nuremberg, 90491
Spain4 sites
Hospital Universitario de A Coruña
A Coruña, 15006
Department of Urology-Hospital Clinic, University of Barcelona
Barcelona, 08036
Complejo Hospitalario Regional Virgen Del Rocio-Department Urology
Seville, 41013
Instituto Valenciano de Oncologia
Valencia, 46009
United Kingdom4 sites
Kings College Hospital (KCH)
London, SE5 9RS
University College London Hospital (UCLH)
London
Oxford John Radcliffe Hospital Trust
Oxford, OX3 7LJ
Royal Hallamshire Hospital
Sheffield
Netherlands2 sites
Netherlands Cancer Institute
Amsterdam, 1066 CX
Catharina Ziekenhuis
Eindhoven
Finland1 site
Department of Urology-Tampere University Hospital-
Tampere, 33521
Italy1 site
Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia
Torino, 10126
About this study
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
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
Read the 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
- Conditions
- Cancer of the Prostate
- Being tested
- no intervention (post study follow up)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention (post study follow up)Other
No intervention (post study follow up)
| Study group | Role | What they receive |
|---|---|---|
| TOOKAD VTP TREATMENT | Subjects randomized in the treatment arm (TOOKAD VTP treatment) in the initial period of the study. Receives: Other: no intervention (post study follow up) | |
| Active surveillance | Subjects randomized in the control group (active surveillance) in the initial period of the study. Receives: Other: no intervention (post study follow up) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Over the 5 years of follow up
Prostate cancer-related death.
Any death related to Prostate cancer
Measured: Over the 5 years of follow up
Secondary outcomes (8)
Absence of cancer
The proportion of absence of cancer at biopsy (when available)
Measured: Over the 5 years of follow up
Radical therapy
The rate of prostate cancer radical therapy;
Measured: Over the 5 years of follow up
Cancer burden
The total cancer burden in the prostate
Measured: Over the 5 years of follow up
Urinary incontinence
The description of incontinence in terms of mean, median, SD, inter-quartile ranges, min-max
Measured: Over the 5 years of follow up
Erectile dysfunction
The description of erectile dysfunction in terms of mean, median, SD, inter-quartile ranges, min-max
Measured: Over the 5 years of follow up
Urethral stenosis
The rate of urethral stenosis
Measured: Over the 5 years of follow up
Prostate cancer complication
The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death
Measured: Over the 5 years of follow up
Patients Questionnaires Quality of life
Overal Quality of Life will be recorded for potential utility and descriptives studies
Measured: Over the 5 years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start17 Mar 2016
- Primary completion3 Jun 2020
- Study completion3 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steba Biotech S.A.
- Sponsor type
- University, hospital or other
- Collaborators
- International Drug Development Institute, ICON plc
- Responsible party
- Sponsor
- Investigators
- Mark EMBERTON, Professor, Principal investigator, University College of London Hospital , United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017325
- Sponsor's protocol ID
- CLIN1001 PCM301-FU5
- Status last verified
- Mar 2021
- First submitted
- 10 Jul 2019
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04017325
- Acronym / sponsor ID
- CLIN1001 PCM301-FU5
- Conditions
- Cancer of the Prostate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Steba Biotech S.A.University, hospital or other
- Collaborators
- International Drug Development Institute, ICON plc
- Study start
- 17 Mar 2016 (actual)
- Primary completion
- 3 Jun 2020 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOOKAD VTP TREATMENT | – | Other: no intervention (post study follow up)Subjects randomized in the treatment arm (TOOKAD VTP treatment) in the initial period of the study. |
| Active surveillance | – | Other: no intervention (post study follow up)Subjects randomized in the control group (active surveillance) in the initial period of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Patients with localized low risk prostate cancer initialy randomized in the study CLIN 1001 PCM301
Key inclusion criteria (9 listed)
- 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):
Key exclusion criteria (9 listed)
- As a reminder, all subjects originally randomized did not met the following criteria at entry (from the original protocol):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention (post study follow up)No intervention (post study follow up) | Other | Active surveillance, TOOKAD VTP TREATMENT |
Primary outcome
Disease progression
Time frame: Over the 5 years of follow up
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.
Other prostate cancer therapy
Time frame: Over the 5 years of follow up
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.
Prostate cancer-related death.
Time frame: Over the 5 years of follow up
Any death related to Prostate cancer
8 secondary outcomes
Absence of cancer
Time frame: Over the 5 years of follow up
Radical therapy
Time frame: Over the 5 years of follow up
Cancer burden
Time frame: Over the 5 years of follow up
Urinary incontinence
Time frame: Over the 5 years of follow up
Erectile dysfunction
Time frame: Over the 5 years of follow up
Urethral stenosis
Time frame: Over the 5 years of follow up
Prostate cancer complication
Time frame: Over the 5 years of follow up
Patients Questionnaires Quality of life
Time frame: Over the 5 years of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark EMBERTON, Professor principal investigator
University College of London Hospital , United Kingdom
36 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of the Prostate, run by Steba Biotech S.A. at 36 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in France, Germany, Spain, United Kingdom, Netherlands and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease progression (time frame: Over the 5 years of follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.