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.
- Conditions
- Prostate Cancer with lymph node metastasesCancer - Prostate
- Registration Number
- ACTRN12621001728820
- Lead Sponsor
- St. Vincent's Prostate Cancer Research Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 20
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the feasibility of radioguided surgery using Tc-PSMA injection to aid intra-operative localisation and resection of lymph nodes at time of extended pelvic lymph node dissection during RARP[Data collection of the number of lymph nodes removed noted in a specified study data collection form and medical records. Also, determined from histopathology report received 24-48 hours post surgery<br>];To evaluate the safety of radioguided surgery using Tc-PSMA injection to aid intra-operative localisation and resection of lymph nodes at time of extended pelvic lymph node dissection during RARP[up to 7 days post surgery as per standard of care, the patient stays as an inpatient in the hospital<br>Safety assessment is determined on follow-up visit data collection form when assessing adverse events and noted in the medical records as per standard of care. <br>]
- Secondary Outcome Measures
Name Time Method To evaluate the diagnostic accuracy of radio-guided surgery with Tc-PSMA injection in detecting small nodal metastases (<4-5mm) in-vivo and ex-vivo by comparing probe results with final pathology after extended pelvic lymph node dissection<br>[Determined from histopathology report received 24-48 hours post surgery and compared with data collected during surgery<br>];To evaluate the quality of life after radioguided surgery using Tc-PSMA by used of validated questionaires (EPIC/IPSS)[assessed Baseline and 6 weeks, 3 months, 6 months, 12 months, 24 months and 36 months (post surgery)]