A prospective randomised multi-centre study of the impact of Ga-68 PSMA-PET/CT imaging for staging high risk prostate cancer prior to curative-intent surgery or radiotherapy

Peter MacCallum Cancer Centre0 个研究点目标入组 302 人开始时间: 2017年1月3日最近更新: 2023年3月13日

适应症

试验速览

暂无简介。

•1. Untreated, biopsy-proven adenocarcinoma of the prostate
•2. Patient is being considered for curative-intent treatment with radical prostatectomy or radiotherapy
•3. Patients must have high-risk features including at least one of the following features:
•- PSA greater than or equal to 20.0 ng/ml within 12 weeks prior to randomisation
•- Gleason group 3, 4 or 5
•- Clinical stage greater than or equal to T3
•4. Age greater than or equal to 18 years
•5. Patient has provided written informed consent for participation in this trial
•6. In the opinion of investigator, willing and able to comply with required study procedures

•1. Participant has had any prior therapy for prostate cancer
•2. Participant has undergone, within 8 weeks prior to randomisation, imaging for the primary purpose of staging nodal or distant metastatic disease of prostate cancer (MRI
•performed for primary purpose of assessing T-stage or to guide biopsy is acceptable)
•3. A history of other active malignancy within the last 5 years with exception of non-melanoma skin cancer or melanoma insitu
•4. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
•5. Significant intercurrent morbidity that, in the judgment of the investigator, would limit compliance with study protocols

发起方

Peter MacCallum Cancer Centre