The study is a prospective, single arm phase I/II study. The primary aim of this study is to evaluate the feasibility of 111In-PSMA I\&T radio guided surgery in patients diagnosed with prostate cancer who are highly suspected of having one or more pelvic lymph node metastases based on pre-operative imaging. Patients with prostate cancer who have a high risk of lymph node metastases based on PSMA PET/CT and scheduled for robot-assisted PLND (with or without prostatectomy) will be recruited. Eligible patients will receive an additional ferumoxtran-10 enhanced MRI to complement pre-operative imaging. Twenty-four hours before surgery, patients will receive the radiolabelled PSMA tracer. Pelvic Lymph node dissections are carried out according to standard of care procedures. During surgery, the surgeon will be provided with a gamma-probe to detect PSMA expressing lymph nodes in vivo. Dissected samples will be systematically assessed on tracer accumulation using the gamma-probe ex vivo. After surgery, the samples will be scanned in the small animal SPECT/CT and 7T-MRI. After scanning, samples will be presented to pathologists for pathological analysis according to standard of care including staining for PSMA expression. At 3 months after surgery, patients will undergo a PSMA-PET/CT. Up until one year after surgery patients will be followed according to standard of care-guidelines by 3-monthly serum-PSA measurements.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
Approximately 24hours prior to surgery (PLND) patients receive a radiolabelled PSMA-tracer. During surgery, urologists will use a gamma-probe to detect PSMA-postitive tumour depostitions in pelvic lymph nodes.
Radboudumc
Nijmegen, Gelderland, Netherlands
Canisius Wilhelimina Ziekenhuis
Nijmegen, Netherlands
Feasibility of 111In-PSMA-I&T radio guided surgery
The primary aim of this study is to evaluate the feasibility of 111In-PSMA-I\&T radio guided surgery in patients diagnosed with prostate cancer who are highly suspected of having one or more pelvic lymph node metastasis/metastases based on pre-operative imaging. Feasibility will be defined as the ability to intra-operatively detect the lymph nodes (using a gamma probe) which were pre-operatively identified on PSMA-PET/CT
Time frame: 1 year
The accuracy of 111In-PSMA-I&T radio guided surgery
Accuracy will be expressed as sensitivity and specificity percentage. Test results of gamma probe (positive or negative) will be compared with histopathology (gold standard) (positive or negative: i.e. containing PSMA-expressing prostate cancer cells).
Time frame: 1 year
The safety of 111In-PSMA-I&T
Safety will be assesed by the number of participants with treatment related adverse events as assessed by CTCAE v4.0. For this outcome measure extra bloodsampling is included in the study protocol.
Time frame: 1 year
Dosimetry of 111In-PSMA-I&T
Blood-clearance ratios will be determined based on radiation dosimetry as assessed by bloodsampling at set time points after injection.
Time frame: 1 year
Correlation between tracer accumulation and lymph node size, PSMA-staining and SUV on PSMA-PET/CT
Time frame: 1 year
Correlation between post-operative nano-MRI and SPECT
Time frame: 1 year
Correlation between pre-operative imaging and postoperative imaging
Time frame: 2 years
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