Localised Prostate Cancer Classification code 10036921
Conditions
Interventions
Product Name: WST09
Product Code: WST09 or TOOKAD
Pharmaceutical Form: Solution for injection
Other descriptive name: Palladium bacteriopheophorbide
Concentration unit: mg/kg milligram(s)/kilogram
Con
Sponsors
STEBA FRANCE
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patients previously treated with WST09-mediated VTP (in Study WST09 2.13); 2. Patients with a positive biopsy of the prostate following treatment with WST09-mediated VTP (in Study 2.13); 3. Disease confined to the prostate (stage T1-N0 or X-M0 or X or T2-N0 or X -M0 or X) without evidence of regional and/or distant disease; 4. Life expectancy greater than 5 years, based on co-morbidity not related to prostate cancer. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Unwilling or unable to give informed consent; 2. Patients who have received another treatment for their prostate cancer since their participation in the previous Study (2.13 study) (except for hormonotherapy); 3. Severe decrease in blood pressure (according to investigator/sponsor advice) related to the study drug during the first WST09 infusion in Study 2.13; 4. Occurrence of a significant adverse event as determined by the Investigator’s and/or the Sponsor’s judgement following treatment with WST09-mediated VTP in Study 2.13; 5. Patients who are currently receiving any photosensitizing medications (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin); 6. Men who are currently receiving anticoagulant drugs (e.g.: coumadin, warfarin) 7. Patient who stopped long-term treatment of acetylsalicylic acid (aspirin) or other anti platelets agents less than 15 days before the procedure; 8. Patients with any contraindication to Low Molecular Weigh Heparin such as high risk of bleeding, severe thrombocytopenia, active bleeding. 9. Any condition or history of illness or surgery that, in the opinion of the investigator and/or the Sponsor, might confound the results of the study or pose additional risks to the patient. Especially patients with significant cardiovascular conditions such as : - Patients with a prior history of coronary artery disease, angina pectoris, myocardial infarction, coronary angioplasty or coronary artery bypass graft, severe valvulopathy, cardiac failure, atrial fibrillation and/or other sustained arrhythmia; - Patients whose current pre-operative cardiac evaluation does not show their fitness for a procedure requiring general anesthesia (for patients with significant cardiac risk factors, this should include a cardiac stress test); - Patients with a history of thromboses or thrombo-embolism, or known risk factors for thromboses; - Patients with a history of peripheral artery diseases; - Patient with a history of stroke or transient ischemic attack; 10. History of non-compliance with medical therapy and/or medical recommendations; 11. Unwilling or unable to complete the patient self-assessment questionnaires; 12. Participation in a clinical study and/or receipt of an investigational treatment or product within the past 90 days (except Study 2.13) 13. History of porphyria; 14. History of significant allergies as judged by the Investigator; 15. Allergies to any components of WST09, particularly to Cremophor® and Benadryl®; 16. History of sun hypersensitivity or photosensitive dermatitis; 17. Renal disorders (blood creatinine > 1.5 times ULN); 18. Hepatic disorders (as confirmed by blood chemistry where transaminases > ULN, bilirubin > ULN, GGT > ULN) at the Inclusion Visit. Blood chemistry may be repeated in case of slight abnormalities. If the result is within the normal range, the patient may be enrolled in the study; 19. Haematological disorders: (White cells < 2500/mm3, neutrophil< 1500/mm3, platelets <140,000/mm3, Hb < 8 g/dl). 20. Patient suspected of Disseminated Intravascular Coagulation (DIC) as defined by the presence of three out of the five following criteria: platelets decrease, increase of PT, increase of aPTT, fibrinogen decrease, D-Dimer increase.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the PDT-induced lesions of a repeat treatment with multifibre illumination and a fixed dose of WST-09 using MR imaging;Secondary Objective: 1 To monitor cancer specific outcomes such as PSA and TRUS guided biopsy of the prostate after repeat treatment of WST09. 2 To monitor the safety and tolerability of a 2nd administration of a fixed dose of WST09 ;Primary end point(s): The primary endpoint will be the prostate biopsy result at Month 6. Success is defined as a negative biopsy (all cores negative). | — |
Countries
United Kingdom
Outcome results
None listed