An interventional study of 68Ga-HBED-CC-PSMA PET / CT in Prostate Cancer Recurrent, sponsored by Institut Cancerologie de l'Ouest. Completed at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-21.
Sponsored by Institut Cancerologie de l'Ouest · Not applicable, Interventional, and Diagnostic
68Ga-HBED-CC-PSMA is a radiopharmaceutical allowing a new imaging modality for the detection of prostate cancer recurrences, used in recent years in clinical studies by some teams mainly in Europe (1-6 ).
The aim of this study is to study the diagnostic performance of 68Ga-HBED-PSMA PET / CT in occult recurrent carcinoma (PCa) by prospectively comparing it to the standard techniques used in this indication: optimized bone scintigraphy with double TEMP / CT systematic and abdominopelvic MRI. The therapeutic impact and tolerance of this examination will also be evaluated.
The expected results are a demonstration of the superiority of 68Ga-HBED-PSMA PET compared to the standard assessment, with a potential impact on the therapeutic management of patients
METHODOLOGY:
Phase II imaging study, prospective, multicenter non-randomized.
MAIN OBJECTIVE:
To determine the added value of 68Ga-HBED-CC-PSMA PET / CT in imaging investigations in terms of the sensitivity of detection of biologic suspected prostate cancer recurrence site locations on the elevation of plasma PSA, while all conventional imaging exams are negative or questionable ("occult recurrence")
SECONDARY OBJECTIVE:
STUDY PROCEDURE :
All the imaging sequences will be done in an outpatient setting. There will be no premedication or other treatment before and after 68Ga-HBED-CC-PSMA PET scans. PET / CT will be performed at participating centers on a hybrid PET camera.
68Ga-HBED-CC-PSMA will be administered to the patient by single intravenous injection (Y-infused with isotonic saline infusion) within 60 min of reconstitution of the radiopharmaceutical.
The first TEP 68Ga-HBED-CC-PSMA whole body acquisition starts 60 min after the injection of 150 MBq of 68Ga-HBED-CC-PSMA and continues for 20-30 minutes, the second full-body acquisition of the same duration takes place 120 minutes after the injection is a total duration of 1 hour of imaging and 2:30 to 3:00 in the service.
Exclusion Criteria:
Patients will receive 68Ga-HBED-CC-PSMA PET / CT imaging for the detection of prostate cancer recurrence sites. This determination will be made at the "patient" and "lesion" level by reference to the gold standard (or truth standard) that will be obtained from the histology data and / or from an imaging and evolution follow-up. PSA over a period of at least 6 months (RECIST 1.1 criteria).
Diagnostic Test: 68Ga-HBED-CC-PSMA PET / CT
Patient will receive a specific PET / CT with PSMA
added value of 68Ga-HBED-CC-PSMA PET / CT in imaging examinations in terms of detection sensitivity of recurrence sites
To determine the added value of 68Ga-HBED-CC-PSMA PET / CT in imaging examinations in terms of detection sensitivity of prostate cancer recurrence sites, biologically suspected of elevated plasma concentrations of PSA, while all conventional imaging tests are negative or questionable: "occult recurrence".
Time frame: 6 months
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Institut Cancerologie de l'Ouest