Patients diagnosed with prostate cancer upon prostate biopsy, who are suspected of having lymph node involvement based upon PSMA-PET/CT.
Conditions
Interventions
Product Name: Indium-111-PSMA-Imaging & Therapy
Product Code: In-111 PSMA-I&T
Pharmaceutical Form: Radiopharmaceutical precursor
INN or Proposed INN: 111-In PSMA-I&T
Other descriptive name: In-111-((R
Sponsors
Radboudumc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: ? Histological proven cancer of the prostate, based on prostate biopsy-core analysis. ? At least one 68Ga/18F-PSMA-PET/CT positive metastasis in lymph nodes, located in pelvis. ? Patient is scheduled and fit for surgery (PLND or prostatectomy +PLND). ? Patient is suitable for PLND (and radical prostatectomy) conform institutional guidelines and is not yet treated pre-operatively. ? Age>18 years. ? Signed informed consent 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: ? No detectable lesion on the 68Ga/18F-PSMA-PET/CT with an uptake level below liver uptake level. ? Patients who are not scheduled for PLND. ? Unequivocal evidence of metastases outside the pelvis. ? Presence of any medical condition that in the opinion of the investigator/treating physician will affect patients’ clinical status by participating in this trial. ? Prior prostate cancer treatment in the form of radio-, hormonal- or chemotherapy. ? Laboratory values at baseline: - White blood cells 3 ULN - GFR < 60 ml/min ? Contraindication for MRI-scanning, i.e. claustrophobia, intracranial metal clips, metallic bodies in the eye, implanted electric and electronic devices not eligible for MRI (pacemakers, insulin pumps, cochlear implants, neurostimulators). ? Inability to lie still for at least 30 minutes or comply with imaging. ? Contraindication for iron infusion or hypersensitivity/allergy to the active substance or any of the excipients. ? The patient is already enrolled in one or more concurrent studies, which would confound the results of this study, according to the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the feasibility of radio-guided Pelvic Lymph node dissection in prostate cancer patients using Indium-111 labelled PSMA_I&T;Secondary Objective: • To compare the intra operative tracer detection (gamma-probe) results with ex vivo findings on SPECT/CT and MRI of resected samples. • To compare both nano-MRI images and SPECT/CT images of resected samples with histopathologic findings. • To correlate intra operative tracer detection results and SPECT/CT images with PSMA-staining on histopathologic examination. • To correlate amount of gamma-counts with tumour(metastases) size. • To assess safety of 111In-PSMA-I&T by monitoring (S)AE’s according to the common terminology criteria for adverse events (CTCAE). ;Primary end point(s): The threshold in absolute gamma counts for identification of tumour-positive lymph nodes. The sensitivity and specificity of intra-operative tumour-positive lymph node detection. ;Timepoint(s) of evaluation of this end point: After histoptahological examination results. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To compare the intra operative tracer detection (gamma-probe) results with ex vivo findings on SPECT/CT and MRI of resected samples. • To compare both nano-MRI images and SPECT/CT images of resected samples with histopathologic findings. • To correlate intra operative tracer detection results and SPECT/CT images with PSMA-staining on histopathologic examination. • To correlate amount of gamma-counts with tumour(metastases) size. • To assess safety of 111In-PSMA-I&T by monitoring (S)AE’s according to the common terminology criteria for adverse events (CTCAE). ;Timepoint(s) of evaluation of this end point: This can be evaluated after the ex-vivo scanning of the samples. | — |
Countries
Netherlands
Contacts
Public ContactDep. Radiology & Nuclear Medicine
Radboud university medical center
Outcome results
None listed