Feasibility of Magnetic Resonance Imaging guided stereotactic reirradiation in patients who have previously received radiation for prostate cancer and have biochemical and local recurrence of cancer within the prostate

Christopher Rumley0 个研究点目标入组 25 人开始时间: 2021年3月4日最近更新: 2022年3月21日

适应症

试验速览

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•Histologically confirmed recurrent prostate cancer, previously treated with external beam radiotherapy or low dose rate (LDR) brachytherapy
•- At least 2 years between completion of primary radiotherapy course and detection of biochemical failure as per by Phoenix definition (PSA nadir + 2)
•- Prostate Specific Antigen (PSA) doubling time > 6 months
•- Life expectancy > 5 years
•- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
•- Magnetic Resonance Imaging (MRI) and/or Prostate Specific Membrane Antigen Positron Emission Tomography (PSMA PET) demonstrating locally recurrent disease involving a single focus within the prostate or seminal vesicles (i.e. multifocal recurrence not permitted)
•- Patients with metastatic disease may be enrolled provided they have oligometastases to no more than 5 sites (lymph node or bone), and all sites are amenable to surgery or Stereotactic Ablative Body Radiotherapy (SABR)
•- Concomitant use of androgen deprivation therapy (ADT) is permissible, but only patients who are not on ADT at the time of enrolment will be analysed for time to second biochemical failure
•- Able to provide written informed consent

•- Prior prostatectomy
•- Inability to undergo MRI (per department MRI safety protocol)
•- Any Grade 2 or higher late genitourinary toxicity believed to be directly related to prior radiotherapy (except in sexual function domain)
•- Any Grade 2 or higher late gastrointestinal toxicity believed to be directly related to prior radiotherapy
•- PSA greater than 20ug/L at time of relapse

发起方

Christopher Rumley