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A European randomised Phase 3 study to assess the efficacy and safety of TOOKAD® Soluble for localised prostate cancer compared to Active Surveillance

Phase 3
Completed
Conditions
prostate cancer
10038597
Registration Number
NL-OMON41452
Lead Sponsor
Steba Biotech SA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
30
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 or greater than 25 cc and less than 70 cc;;5) Male subjects aged 18 years or older.

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
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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