Prospective trial comparing nanoparticle-magnetic resonance lymphography and 68Ga-PSMA positron emission tomography in nodal staging of prostate cancer

Not Applicable

Recruiting

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12619000088145
• Lead Sponsor: Garvan Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-22
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

•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

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We will compare ‘packet concordance rate’ between histology and MR Lymphography using a MRA arterial map (that can be acquired at the MRL) to locate the position of the lymph node, the 68Ga PSMA PET SCAN plus a combined evaluation, and histology. [When histopathology of lymph node dissection is available. ]

Secondary Outcome Measures

Name	Time	Method
As part of initial longitudinal analyses quality of life (as measured using EORTC-QLQ-C30) will be evaluated using one-way ANOVA. [As follow-up data becomes available, continuous reanalysis will occur. Initially at 3 months, then 6 months then 12 months and yearly from then until lost to follow-up or death. ]