A Randomised Trial of External Beam Radiation Therapy (EBRT) Alone versus EBRT in Combination with 177Lu-PSMA Theranostic in Patients with Biochemically Recurrent Prostate Cancer (to determine the proportion of participants in each group with a 50% decline in PSA through to the end of the trial) - a phase 3 study

GenesisCare0 个研究点目标入组 186 人开始时间: 2018年10月10日最近更新: 2018年11月12日

适应症

试验速览

暂无简介。

•Written informed consent
•Male, aged 45 years or more
•Estimated life expectancy of at least 6 months
•Eastern Cooperative Oncology Group (ECOG) score 0 or 1
•Previous radical prostatectomy (RP) with curative intent
•Biopsy proven prostate adenocarcinoma
•Biochemical relapse (any serum PSA level)
•Significant avidity (SUVmax of at least 9) on 68Ga-PSMA-ligand PET/CT, with visualised disease confined to the pelvis and outside the prostatic bed
•Metastatic lymph nodes not beyond the aortic bifurcation
•Androgen deprivation therapy (ADT) naïve
•Chemotherapy naïve
•Adequate renal function: Cr Cl greater than or equal to 40 mL/min (determined by Cockcroft-Gault formula)
•Adequate bone marrow function: platelets greater than or equal to 100 x 109/L (within normal limits); Hb greater than or equal to 90 g/L (within normal limits); neutrophils greater than or equal to 1.5 x 109/L
•Adequate liver function: bilirubin < 1.5 x upper limit of normal (ULN); AST, ALT, AP < 2 x ULN; albumin > 30 g/L
•Willing and able to comply with all study requirements, including all treatments and pre- and post-treatment assessments
•Able to commence treatment within 28 days of randomisation

•Previous external beam radiotherapy to prostatic bed
•Bone or visceral metastases
•Lymph node metastases above the aortic bifurcation
•Presence of > 5 metastatic lymph nodes
•Contraindications to pelvic irradiation (e.g., chronic inflammatory bowel disease, previous radiotherapy to pelvic malignancy)
•Known hypersensitivity to any isotope of Lu in any chemical form, or any isotope of Ga in any chemical form, or any of the PSMA-targeting ligands
•Evidence of urinary tract stricture, or significant urinary incontinence
•Presence of active infection at time of screening, or history of serious infection within the previous 4 weeks
•Any uncontrolled significant medical, psychiatric or surgical condition (eg. active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled type 2 diabetes, uncontrolled congestive heart disease, pulmonary disease, etc.), or laboratory findings that, in the opinion of the investigator, might jeopardise the patient’s safety or that would limit compliance with the treatment and assessment requirements of this study
•History of any malignancy other than prostate cancer within five years of enrolment (excluding localised non-melanoma skin cancers)
•Any mental condition or cognitive impairment that may render the patient unable to adequately understand the requirements, nature and possible consequences of the study

发起方