Phase I/II study of Short-course Hypofractionated Once-weekly Radiation Therapy (SHORT) for localized prostate cancer - SHORT

Tata Medical Center0 个研究点目标入组 30 人开始时间: 待定最近更新: 2023年5月1日

试验速览

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•Histologically confirmed prostate adenocarcinoma.
•History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
•Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material.
•Clinical stage T1-T4N0M0 (AJCC 7th edition). Staging demands
•oa multiparametric MRI of the pelvis
•oa CT or MRI of the abdomen for T3/T4 tumors or PSA >10
•oa whole body bone scan for T3/T4 tumors or PSA >10
•PSA < 60 ng/mL within 180 days prior to registration. PSA should not be obtained for at least 10 days after prostate biopsy.
•WHO performance status 0-1
•Age >= 18
•Patient must sign study specific informed consent prior to accrual.

•Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
•Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
•Previous pelvic irradiation in any form.
•Previous hormonal therapy of more than 180 days duration prior to registration.
•Previous or concurrent cytotoxic chemotherapy for prostate cancer
•Severe, active comorbidity, defined as follows:
•oUnstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
•oTransmural myocardial infarction within the last 6 months
•oAcute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
•oChronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
•oHepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. (Patients on Coumadin or other blood thinning agents are eligible for this study.)
•oRenal insufficiency with a creatinine clearance of <30ml/min

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