Status:
COMPLETED
European Randomised Study of TOOKAD® Soluble for Prostate Cancer vs Active Surveillance. Post Study Follow-up
Lead Sponsor:
Steba Biotech S.A.
Collaborating Sponsors:
International Drug Development Institute
ICON plc
Conditions:
Cancer of the Prostate
Eligibility:
MALE
18+ years
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 interventio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
March 17 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 3 2020
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT04017325
Start Date
March 17 2016
End Date
June 3 2020
Last Update
March 22 2021
Active Locations (36)
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1
Department of Urology-Tampere University Hospital-
Tampere, Finland, 33521
2
Centre Hospitalier Universitaire (CHU)
Angers, France
3
CHRU Hopital Jean Minjoz
Besançon, France, 25030
4
Site Médipole
Cabestany, France, 66330