None listed
Conditions
Brief summary
The purpose of this study is to determine if new imaging technologies are a valid and accurate method of detecting lymph node metastases. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with prostate cancer. Study details All participants will have 2 specialised imaging scans (68Ga-PSMA PET and nano-MRL) prior to a prostatectomy and lymph node dissection. It is hoped that this research will help determine if these two imaging tests are useful in providing accurate but non-invasive methods of diagnosing metastatic prostate cancer. Thus guiding better targeted treatment.
Interventions
1. Men diagnosed with prostate cancer are referred to a participating urologist for a radical prostatectomy
2. The patients are consented to the study by the urologist or research assistants following fulfilment of the inclusion criteria
3. The patient is referred to a Department of Nuclear Medicine (St Vincent's Hospital Sydney or The Wesley Hospital Brisbane) where a 68Ga-PSMA (68Gallium-Prostate Specific Membrane Antigen Positron Emission Tomography: using a radioactive labelled antigen, p
1. Men diagnosed with prostate cancer are referred to a participating urologist for a radical prostatectomy 2. The patients are consented to the study by the urologist or research assistants following fulfilment of the inclusion criteria 3. The patient is referred to a Department of Nuclear Medicine (St Vincent's Hospital Sydney or The Wesley Hospital Brisbane) where a 68Ga-PSMA (68Gallium-Prostate Specific Membrane Antigen Positron Emission Tomography: using a radioactive labelled antigen, positron emission tomography can detect lymph node metastases) PET Scan is performed 5. On the return visit, “Combidex” is administered at 2.6 mg Fe/kg intravenously after dilution in 300mls of normal saline to the patient by trained and qualified nursing staff and the patient is referred for a MRI scan (Medscan Barangaroo or The Wesley Hospital Brisbane) - this will constitute the 'MRL scan' (Nanoparticle-magnetic resonance lymphography (Combidex Nano MRL): using nanoparticle iron oxide particles as a contrast agent, magnetic resonance imaging can detect lymph node metastases at 2mm in size) 6. Radiologist and Urologist annotate suspect lymph nodes using the Pelvic Lymph Node Diagnostic Template and assign index of suspicion to each area 7. Patient undergoes radical prostatectomy including the removal of lymph nodes 7-10 days following Combidex nano-MRL 8. The prostate and the lymph nodes are sent to histology for reporting 9. Analysis: a. Histology Vs Nano-MRL b. Histology Vs Ga68 PSMA PET c. Histology Vs Nano-MRL Vs Ga68 PSMA PET 10. Repeat Ga68 PSMA and Nano-MRL if not concordant with Histology within 6-8 weeks of surgery 11. Follow up Visits: The participant will have clinical follow up reviews as part of their care at 6 weeks, 3 months, 6 months, 12 months and 24 months 12. Participant will complete the Expanded Prostate Cancer Index Composite (EPIC) survey at baseline (prior to surgery), 6 weeks, 3 months, 6 months, 1 years and then yearly for a minimum of 5 years).
Sponsors
Garvan Institute of Medical Research
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed