Know Cancer

forgot password

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
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance

This is a Phase 3, multicentre, open label, randomised controlled study in subjects
diagnosed with low risk prostate cancer on TransRectal Ultrasound (TRUS) guided biopsy.

Subjects will be randomised to either Active Surveillance or TOOKAD® Soluble VTP. Subjects
will remain in the study for approximately 24 months following randomisation. A total of 400
subjects will be entered into the study; 200 will receive Active Surveillance and 200 will
receive TOOKAD® Soluble-VTP.

Inclusion Criteria:

Subjects will be eligible for inclusion in the study if all of the following criteria are

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

- Gleason 3 + 3 prostate adenocarcinoma as a maximum,

- Two (2) to three (3) cores positive for cancer

- 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

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:

Subjects will not be eligible for the study if meeting any of the following 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 the study tasks. Subject in custody and or in residence in a nursing home or
rehabilitation facility

8. Contra-indication to Magnetic resonance Imaging (MRI) (e.g., pacemaker, history of
allergic reaction to gadolinium), or factors excluding accurate reading of pelvic MRI
(e.g., hip prosthesis)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Co-primary endpoint 'A': Rate of absence of definite cancer using patients on active surveillance as a comparison.

Outcome Description:

Histological changes are assessed using biopsies or any other pathology result obtained during the study planned or not.

Outcome Time Frame:

Month 24

Safety Issue:


Principal Investigator

Mark Emberton, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

University College of London Hospital , United Kingdom


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

CLIN1001 PCM301



Start Date:

February 2011

Completion Date:

September 2015

Related Keywords:

  • Prostate Cancer
  • Prostatic Disease
  • Genital Neoplasm,male
  • Urogenital neoplasm
  • Genital disease,male
  • Male urogenital disease
  • Neoplasms
  • Neoplasms by site
  • Prostatic neoplasm
  • Carcinoma
  • Prostatic Neoplasms