Radioguided Surgery With Technetium99m-labelled PSMA To Aid Intra-operative Lymph Node Metastases Detection For Patients Undergoing Robotic-assisted Radical Prostatectomy (RARP) For Prostate Cancer.

St. Vincent's Prostate Cancer Research Centre0 个研究点目标入组 20 人开始时间: 2021年12月17日最近更新: 2021年12月27日

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•Patients must meet the following inclusion criteria to be eligible to participate in the study:
•Male, aged 18 years or over
•Confirmed adenocarcinoma of prostate and at least clinical stage T3A and/or Gleason sum greater than or equal to 4+3=7, or preoperative PSA greater than or equal to 15 ng/ml and planned radical prostatectomy
•Suspected lymph node involvement pre- radical prostatectomy based on Briganti nomogram greater than or equal to 10%.
•Had a prior 68Ga-PSMA PET Scan prior to surgery within 90 days prior to surgery with greater than or equal to 1 lymph node with suspicion for metastases
•Suitable for radical prostatectomy and pelvic lymph node dissection, as per institutional guidelines and not yet treated (pre-prostatectomy)
•Subject is able to understand and willing to sign the participant information statement and consent form
•Subject is expected to remain available for 24 months of clinic visits

•Patients who meet any of the following exclusion criteria are not eligible to participate in the study:
•Past history any other type of cancer (except skin cancer).
•Previous treatment for PCa (surgery, radiotherapy, chemotherapy, hormone androgen deprivation therapy)
•Proven bony metastatic disease, visceral metastases or lymph node metastases above the level of the aortic bifurcation (ie unequivocal evidence of disease outside the pelvis on conventional imaging)
•Previous surgery in pelvis that may limit the extent of PLND (as per assessment by surgeon)
•Patients who refuse radical prostatectomy or PLND
•Patients who refuse to join the trial or are unable to consent
•Patients not being considered for further therapy
•Contra-indication to PSMA-PET scanning or allergy to other injectable contrast media used in this trial
•Patients who cannot lie still for at least 30 minutes or comply with imaging
•Subject has medical conditions that would limit study participation (per physician discretion)
•Subject is enrolled in one or more concurrent studies that would confound the study results of this study as determined by the study investigators
•Subject has a limited life expectancy that would not allow completion of the 24 month visits

发起方

St. Vincent's Prostate Cancer Research Centre