Patients diagnosed with biochemical (PSA) relapse following curative intended treatment (defined as radical prostatectomy or radiotherapy, either by external beam radiotherapy or low- or high-dose brachytherapy, or any combination of these) will be included in this study. MedDRA version: 17.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.1 Level: PT Cl
Conditions
Interventions
Product Name: 68Ga-PSMA-HBED-CC
Product Code: 68Ga-PSMA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 68Ga-PSMA-HBED-CC
Other descriptive name: 68Ga-‘2-[3-(1-Carboxy-5-{6-[3-(3-{[(2
Sponsors
Department of Nuclear Medicine, Aalborg University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: A subject is eligible for the study if all of the following apply: Oral and written informed consent. 18 years and older. The patient has undergone a curatively intended treatment for prostate cancer, which is considered to be radical at the end of the intervention/procedure. Confirmed PCa recurrence (defined as PSA = 0.2 ng/ml or more after radical prostatectomy or a rise of 2.0 ng/ml above the post-treatment PSA-nadir following radiation therapy). Subject is able to lie still for the duration of the imaging procedure. 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 60
Exclusion criteria
Exclusion criteria: History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer and prostate cancer. History of allergic reactions attributed to compounds of 68Ga-PSMA radiotracer. Subjects unable to undergo the PET/CT imaging procedure due to claustrophobia despite oral anxiolytics (institutional procedure). Subjects weighing greater than 180 kilograms (weight limit for scanner table), or unable to fit within the imaging gantry. Subjects with any medical condition or other circumstances (e.g. claustrophobia, unable to lie still, unable to comply with study procedures etc.) that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study. If the patient refuses MRI or is not eligible (e.g. claustrophobia or other reasons as outlined in the ESUR guideline for MRI), the patient will be offered a diagnostic CT in combination with 68Ga-PSMA PET. If the patient refuses a diagnostic CT scan or allergic or ineligible for such procedure only a 68Ga-PSMA PET/low dose CT will be performed. Such patients will be assessed for secondary endpoints only.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if 68Ga-PSMA PET/CT can detect prostate cancer recurrence, particularly at low PSA levels, and to identify if recurrence is confined to the prostatic bed, lymph nodes and/or bones.;Secondary Objective: To investigate if 68Ga-PSMA PET/CT is superior to anatomical MRI as well as diffusion-weighted (DW-) MRI in the detection of local recurrence, lymph node metastases and bone metastases in the axial skeleton in prostate cancer recurrence. To assess if 68Ga-PSMA PET/CT is superior to 18F-fluoride PET/CT in the detection of bone metastases in patients with prostate cancer recurrence at whole body level. To evaluate the added clinical value of 68Ga-PSMA PET/CT in terms of change of management by access to the results of 68Ga-PSMA PET/CT and anatomical MRI. A post-hoc analysis will be made with DW-MRI (which is read after the end of the study).;Primary end point(s): Detection rate of prostate cancer recurrence at low PSA levels for 68Ga-PSMA PET/CT.;Timepoint(s) of evaluation of this end point: Evaluation will happen continually as a patient completes the study specific imaging modalities. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparison of 68Ga-PSMA PET/CT with anatomical and DW-MRI of lesion-based detection rate of prostate cancer recurrence. Comparison of 68Ga-PSMA PET/CT and 18F-Fluoride PET/CT in detection of bone metastases. The impact of 68Ga-PSMA PET/CT if patient management;Timepoint(s) of evaluation of this end point: Evaluation will happen continually as a patient completes the study specific imaging modalities. | — |
Countries
Denmark
Contacts
Public ContactLars Jelstrup Petersen
Department of Nuclear Medicine, Aalborg University Hospital
Outcome results
None listed