Detection of lymph node metastasis in prostate cancer.
Conditions
Sponsors
Radboudumc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Male, aged 18 years (or older, if required by local law) - Prostate cancer present (Gleason = 7) and/or PSA = 15 and/or Clinical or radiological Stage T3 - Suspected lymph node involvement pre-prostatectomy - Suitable for radical prostatectomy and pelvic lymph node dissection, as per institutional guidelines and not yet treated pre-prostatectomy - Subject is willing to sign and date the study Informed Consent form - Signed, written informed consent - Subject is expected to remain available for 24 months of clinic visits Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - Previous treatment for prostate cancer (surgery, radiotherapy, chemotherapy, hormone androgen deprivation therapy) - Proven metastatic disease - Patients who refuse 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 - Contra-indication to MRI scanning, IV iron infusion, allergy to dextran or other injectable contrast media used in this trial - Patients who cannot lie still for at least 30 minutes or comply with imaging - Unequivocal evidence of disease outside the pelvis on conventional imaging - Subject has medical conditions that would limit study participation (per physician discretion) - Subject has hemochromatosis and liver disease - Subject has known allergy against Fe-products or dextranes - 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 - Subject meets the exclusion criteria required by local law
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prospectively determine the combined value of 68 Ga-PSMA-PET/CT and Nano-MR Lymphography (Ferumoxtran-10) for the detection of metastases in patients with prostate cancer at intermediate to high risk with PLND and image directed dissection as gold standard.;Secondary Objective: Not applicable.; Primary end point(s): Primary endpoints: 1. Diagnostic a. Concordance of Ga68PSMA and Nano MRL (a) b. Histology of LND (b) c. Concordance of (b) with (a) d. Results of reimaging after LND 2. Therapeutic a. Response to treatment – return to negative testing after either RT or ADT or both (using PSA as a surrogate marker of biochemical free disease status, as is currently common practice) ; Timepoint(s) of evaluation of this end point: All patients fulfilling the entry criteria being referred for diagnosis and initial lymph node staging of prostate cancer will have pre-operative routine (mandatory) bone scan and diagnostic CT, as well as Nano MRL and 68Ga PSMA PET/CT, as follows: - 68Ga PSMA PET/CT - Diagnostic CT - Pelvic MRI - Routine Bone scan - Post-imaging staging (for patients with positive imaging but negative histology of lymph node specimens) Re-scanning will be carried out after the surgery to confirm that the nodes have been removed for those patients whose imaging results were discordant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Netherlands
Contacts
Public ContactRadiology and Nuclear Medicine
Radboudumc
Outcome results
None listed