To determine whether use of Technetium99m-labelled PSMA improves the sensitivity for detection and aids intra-operative localisation of lymph node metastases in men with intermediate or high-risk localised prostate cancer undergoing robotic-assisted radical prostatectomy.
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 Centre
20 participants
Jun 26, 2019
Interventional
Conditions
Summary
The purpose of this study is to determine whether it is feasible and safe to use Technetium99m-labelled PSMA as a tracer during prostate removal surgery (or a 'radical prostatectomy') for men with prostate cancer. Who is it for? You may be eligible for this study if you are an adult male, who has been diagnosed with prostate cancer and is scheduled to receive a radical prostatectomy. Study details All participants will be asked to come into the hospital around 3-4pm the day before the surgery to receive an injection of the tracer and a scan. Once they have received the tracer, they will be observed for a while before going home. All participants will then proceed with the surgery as planned the next day. It is hoped that this study will be able to determine whether using Technetium99m-labelled PSMA as a tracer during radical prostatectomy is safe and results in better detection of any cancer that may have spread. Follow-up visits To determine the outcome of treatment, the participant will be asked to complete the self-reporting Expanded Prostate Cancer Index Composite (EPIC) survey. The EPIC survey has been extensively used to report on the physical, emotional and psychological outcomes of prostate cancer. The questionnaires will be completed at baseline (prior to surgery), at 6 weeks, 3 months, 6 months, 1 year and then yearly for a minimum of 3-5 years
Eligibility
Inclusion Criteria7
- 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
Exclusion Criteria12
- 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
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Interventions
Participants will be recruited at the St. Vincent's Prostate Cancer Research Centre with high-intermediate and high-risk cancer patients with a greater than or equal to 10% probability of LN involvement, where radical prostatectomy and ePLND would currently be performed as part of standard of care treatment (guided by the updated Briganti nomogram). The nuclear medicine physicians will be in charge of administration of the Tc-PSMA radiopharmaceutical. On the day prior to surgery at approximately 3-4pm, 500MBq of Tc-PSMA will be intravenously administered to the patient at St Vincent’s Hospital in the nuclear medicine department. After a period of observation, patients will be allowed to return home, and then present for their procedure the next day. On the day of surgery, Radioguided surgery for lymph node metastases will involve use of a robot-assisted drop-in gamma detection probe connected to a gamma detection device (Navigator GPSTM Control Unit), which will be able to provide visual and acoustic feedback gamma count levels.
Locations(1)
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ACTRN12621001728820