STUDY OF THE EFFICACY, SAFETY AND QUALITY OF LIFE AFTER TOOKAD® SOLUBLE VASCULAR TARGETED PHOTODYNAMIC THERAPY (VTP) FOR MINIMALLY INVASIVE TREATMENT OF LOCALIZED PROSTATE CANCER.

Steba biotech S.A,0 个研究点目标入组 18 人开始时间: 2013年9月16日最近更新: 2023年9月4日

试验速览

暂无简介。

•Subjects will be eligible for inclusion in the study if all of the following criteria are met:
•Histologically proven localized prostate carcinoma diagnosed using available prostate biopsy showing:
•Gleason 3+3 Gleason 3+4 is acceptable provided it is not present in more than 2 cores and no more than 50% cancer in any core.
•Clinical stage up to cT2a – N0/Nx – M0/Mx.
•Prostate volume ≥ 25 cc and ≤ 70 cc.
•Serum prostate-specific antigen (PSA) < 20 ng/mL.
•Male subjects aged 18 years or older.
•Signed Informed Consent Form by the patient.

•Subjects will not be eligible for the study if meeting any of the following criteria:
•Unwillingness to accept the treatment.
•Any prior or current treatment for prostate cancer, including surgery, radiation therapy
•(external or brachytherapy) or chemotherapy.
•Any surgical intervention for benign prostatic hypertrophy.
•Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure.
•Life expectancy less than 10 years.
•Participation in another clinical study involving an investigational product within 1 month before study entry.
•Subject unable to understand the patient’s informed consent document, to give consent voluntarily or to complete the study tasks, especially unable to understand and fulfill the health-related QoL questionnaire. Subject in custody and or in residence in a nursing home or rehabilitation facility.

发起方

Steba biotech S.A,