A European randomised Phase 3 study to assess the efficacy and safety of TOOKAD® Soluble for localised prostate cancer compared to Active SurveillancePost-study 5-year follow-up protocol has now been included.

• Conditions: ocalised prostate cancer; MedDRA version: 18.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-021900-93-DE
• Lead Sponsor: STEBA BIOTECH SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-13
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 413

Inclusion Criteria

1) Low risk prostate cancer diagnosed using one transrectal 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 to or greater than 25 cc and less than 70 cc,
4) Male subjects aged 18 years or older.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1) Unwillingness to accept randomisation 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 study tasks. Subject in custody 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified