TRANSPERINEAL PROSTATE BRACHYTHERAPY, USING I-125 SEED WITH OR WITHOUT ADJUVANT ANDROGEN DEPRIVATION, IN PATIENTS WITH INTERMEDIATE-RISK PROSTATE CANCER: STUDY PROTOCOL FOR A PHASE III, MUTICENTER, RANDOMIZED, CONTROLLED TRIAL - SHIP0804

Egawa Shin0 个研究点目标入组 420 人开始时间: 2019年3月13日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1.Prostate cancer classified as an intermediate risk group from clinical stage, PSA value, Gleason score of central pathology diagnosis.
•2. Be previously untreated Pca.
•3. ECOG PS is 0 or 1
•4.The age at consent acquisition is between 20 years old and 75 years old.
•5.Laboratory test values satisfy the following criteria.
•1) White blood cell count over 3000 / myu L
•2) Hemoglobin over 10.0 g / dL
•3) Number of platelets over 100000 / myu L
•4) Serum creatinine under 2.0 mg / dL
•5) AST (GOT) under 100 IU / L
•6) ALT (GPT) under 100 IU / L
•6. Agree in writing to participate in this clinical study after receiving adequate explanation.

•1. Have PSA over 20 ng/mL.
•2. Have a biopsy Gleason score over 8.
•3. Exhibit clinical stage over T2c.
•4. Have a second cancer that requires treatment.
•5. Have poorly-controlled hypertension (diastolic pressure over 120mmHg)
•6. Have a severe psychiatric disorder, including schizophrenia and dementia.
•7. Have collagen disease diabetes.
•8. Have poorly-controlled diabetes.
•9. Have previously received surgery for PCa.
•10. Are using steroid drugs other than topical ointments.
•11. Are using antiandrogenic therapy.
•12. Are for any other reason considered by a Principal Investigator or Clinical Investigator to be inappropriate for participation in the present study.

发起方

Egawa Shin