Prospective evaluation of lymph node imaging for the nodal staging of prostate cancer with a high risk of lymph node metastases: A prospective cohort study to determine the concordance between two imaging modalities, Combidex” Nanoparticle-Magnetic Resonance Lymphography (Nano MRL) and 68Ga-PSMA positron emission tomography (PET)

Garvan Institute of Medical Research0 个研究点目标入组 120 人开始时间: 2019年1月22日最近更新: 2020年2月10日

适应症

试验速览

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•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 equals 15 ng/ml and planned radical prostatectomy
•Suspected lymph node involvement pre- radical prostatectomy based on Briganti nomogram greater than or equal to 10%.
•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

•Past history any other type of cancer (except skin cancer).
•Previous treatment for prostate cancer (surgery, radiotherapy, chemotherapy, hormone androgen deprivation therapy)
•Proven bony metastatic disease, visceral metastases or lymph node metastases above the level of the aortic bifurcation
•Previous surgery in pelvis (e.g. bilateral hip replacement) that limit the extent of pelvic lymph node dissection
•Patients who refuse radical prostatectomy or pelvic lymph node dissection
•Patients who refuse to join the trial or are unable to consent
•Patients not being considered for further therapy
•Patient has absolute contra-indications to undergoing MRI scanning
•Patients who cannot lie still for at least 60 to 75 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

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