EUCTR2006-001530-40-GB进行中（未招募）不适用
Vascular targeted photodynamic therapy using WST09 for patients with untreated localised prostate cancer - Repeat procedure – Phase IIa, Single centre, open-label study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- STEBA FRANCE
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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
排除标准
- •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.
研究者
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