EUCTR2008-000876-26-NL进行中（未招募）不适用
Vascular-targeted photodynamic therapy using WST11 in patients with localised prostate cancer
STEBA BIOTECH N.V.0 个研究点目标入组 24 人开始时间: 2008年6月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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. Men over 18 years of age;
- •2. Diagnosed with prostate cancer and eligible for active surveillance;
- •3. No prior treatment for prostate cancer;
- •4. Prostate Cancer Stage up to cT2b – N0/Nx – M0/Mx (rT2c and pT2c are acceptable);
- •5. Gleason score = 3+3
- •For patients characterized with prostate mapping (transperineal template guided biopsy at 5mm intervals) a secondary pattern 4 is acceptable provided that it is not present in more than 3 cores from each side of the prostate and is no more than 3 mm cancer core length.
- •6. PSA < 10 ng/mL;
- •7. Signed Informed Consent Form.
- •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. 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.
- •2. All patients whose current pre-operative cardiac evaluation does not show their fitness for a procedure requiring general anesthesia;
- •3. Patients with a prior history of viral or alcoholic hepatitis, and other patients felt to be at risk for hepatotoxicity including concomitant use of potentially hepatotoxic medications or dietary supplements;
- •4. Patients with a history of inflammatory bowel disease or other factors which may increase the risk of fistula formation;
- •5. Men who have received any hormonal manipulation (excluding 5-alpha reductase inhibitors) or androgen supplements within the previous 6 months;
- •6. Men previously treated by radiation therapy (external therapy or brachytherapy) or chemotherapy or any therapy for prostate cancer;
- •7. Men who have received or are receiving chemotherapy for prostate carcinoma or other significant cancer;
- •8. Men who have undergone previous TURP (trans-urethral resection of the prostate);
- •9. Men who are currently (within the month before the treatment procedure) receiving any medications having potential photosensitizing effects (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin);
- •10. Men who are currently receiving anticoagulant drugs (e.g.: coumadin, warfarin)
- •11. Patient who stopped long term treatment of acetylsalicylic acid (aspirin) or other anti platelets agents less than 15 days before the procedure;
- •12. 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.
- •13. History of non compliance with medical therapy and medical recommendations or an unwillingness or inability to complete patient self-administered questionnaires;
- •14. Participation in a clinical study or receipt of an investigational treatment within the past 3 months;
- •15. A history of porphyria;
- •16. A history of sun hypersensitivity or photosensitive dermatitis;
- •17. Renal disorders (blood creatinine > 1.5 x ULN) or known post mictional residue > 150cc
- •18. Hepatic disorders (transaminases > ULN, bilirubin > ULN, GGT > ULN). In case of slight abnormalities, another exam could be performed. If the results are within normal ranges, then the patient can be included;
- •19. Hematological disorders (white cells < 2500/mm3, neutrophils < 1500/mm3, platelets < 140.000/mm3, Hb < 8 g/dL);
- •20. Patient with contra-indication to MRI (such as pace maker, metal prosthesis, etc.).
研究者
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