Status:
COMPLETED
Study of 68Ga-HBED-PSMA PET/CT and Conventional Imaging in Occult Biological Relapse Prostate Cancer
Lead Sponsor:
Institut Cancerologie de l'Ouest
Conditions:
Prostate Cancer Recurrent
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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-...
Detailed Description
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 se...
Eligibility Criteria
Inclusion
- Age above 18 years
- Diagnosis of histologically proven prostate cancer.
- Patient having benefited from previous curative treatment (prostatectomy, radiotherapy, ultrasound, cryotherapy ...), with a significant decrease in the plasma concentration of PSA at the end of treatment (= indisputable PSA)
- Biologic recurrence documented by abnormal results in 2 assays of plasma PSA concentration in the same laboratory.
- Value of the plasma concentration of the last PSA assay during the 4 months preceding D0: 0.05 ng / mL ≤ PSA \<1.6 ng / mL
- Conventional imaging assessment already carried out, including at least one optimized skeleton scintigraphy with thoracoabdominopelvic TEMP / CT (or 18F-Choline TEP) and pelvic MRI (or abdominopelvic CT if contraindicated MRI) less than 6 weeks old. All of these tests must have been interpreted as "negative" or "questionable" (without "suggestive" or "suspect" aspects of malignancy) written by the imaging specialist.
- Karnofsky ≥ 70 or ECOG 0-1
- Life expectancy of at least 6 months
- The patient has given his written consent.
- Patient affiliated to a social security scheme
Exclusion
- Another progressive cancerous condition, except for basal cell cancers.
- Acute inflammatory condition,
- Implementation of treatment (eg chemotherapy) or change of treatment (eg hormone therapy) since skeletal scintigraphy, abdominopelvic MRI or the last serum PSA test.
- Radiotherapy, chemotherapy or other anti-tumor treatment during the 6 weeks preceding PET,
- Agitation; impossibility to hold motionless for at least 1 hour, or known claustrophobia
- Poor predictable compliance or inability to undergo medical follow-up of the test for geographical, social or psychological reasons,
- Intellectual inability to sign informed consent
- Persons deprived of liberty or guardianship (including trusteeship),
Key Trial Info
Start Date :
March 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2019
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03443609
Start Date
March 31 2017
End Date
September 29 2019
Last Update
May 21 2021
Active Locations (1)
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1
ICO René Gauducheau
Saint-Herblain, France, 44805