Phase 3 Tookad® Soluble in low-risk localised prostate cancer patients

• Research type

  Research Study

• Full title

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

• IRAS ID

  61013

• Contact name

  Mark Emberton

• Sponsor organisation

  STEBA BIOTECH SA

• Eudract number

  2010-021900-93

• ISRCTN Number

  n/a

• Research summary

  We are investigating the use of an experimental procedure, which has the potential to be a future treatment for prostate cancer. It is called Vascular Targeted Photodynamic therapy (VTP). It uses a special drug called a photosensitiser, which makes the body sensitive to light. This drug is given into the bloodstream by infusion into a vein and spreads throughout the body. For the drug to work it needs to be activated by laser light which is given at the same time as the photosensitiser. Light is directed into the prostate gland through optical fibris, which are put into the prostate through thin needles inserted through the skin between the scrotum and the back passage. The light activates the drug to cause tissue destruction in the prostate. The entire procedure is performed using a general anaesthetic. Effective pain relief will be provided after the anaesthetic for as long as required after the treatment. The goals of the study are to compare between men with low risk prostate cancer who undergo TOOKAD© Soluble VTP and men on active surveillance.We envisage treating up to 400 patients who will have equal chances to be randomized (treatment assignment done by chance) to either Active Surveillance or TOOKAD© Soluble VTP.patientsenrolled in the TOOKAD© Soluble VTP arm will be treated with 4mg/kg of TOOKAD© Solubleand one energy dose of 200 J/cm. The efficacy of this treatment will be evaluated using a special scan (Magnetic resonance Imaging, MRI), the PSA (prostate-specific antigen) level and prostate biopsies. This new procedure could be an alternative to the current Active Surveillance approach, with fewer complications than after surgery or radiotherapy.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  10/H0604/79

• Date of REC Opinion

  17 Dec 2010

• REC opinion

  Further Information Favourable Opinion