Clinical trial · Interventional
Study of 68Ga-HBED-PSMA PET/CT and Conventional Imaging in Occult Biological Relapse Prostate Cancer
Diagnostic Multicenter Phase II Study, Prospective, Comparative, of 68Ga-HBED-PSMA PET / CT and Conventional Imaging Procedures in Occult Biological Relapse Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-HBED-CC-PSMA PET / CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 68Ga-HBED-CC-PSMA PET / CT
- description
- 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).
- interventionNames
- Diagnostic Test: 68Ga-HBED-CC-PSMA PET / CT
Primary outcomes (1)
- measure
- added value of 68Ga-HBED-CC-PSMA PET / CT in imaging examinations in terms of detection sensitivity of recurrence sites
- timeFrame
- 6 months
- description
- 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".
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age above 18 years 2. Diagnosis of histologically proven prostate cancer. 3. 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) 4. Biologic recurrence documented by abnormal results in 2 assays of plasma PSA concentration in the same laboratory. 5. 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 6. 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. 7. Karnofsky ≥ 70 or ECOG 0-1 8. Life expectancy of at least 6 months 9. The patient has given his written consent. 10. Patient affiliated to a social security scheme Exclusion Criteria: 1. Another progressive cancerous condition, except for basal cell cancers. 2. Acute inflammatory condition, 3. Implementation of treatment (eg chemotherapy) or change of treatment (eg hormone therapy) since skeletal scintigraphy, abdominopelvic MRI or the last serum PSA test. 4. Radiotherapy, chemotherapy or other anti-tumor treatment during the 6 weeks preceding PET, 5. Agitation; impossibility to hold motionless for at least 1 hour, or known claustrophobia 6. Poor predictable compliance or inability to undergo medical follow-up of the test for geographical, social or psychological reasons, 7. Intellectual inability to sign informed consent 8. Persons deprived of liberty or guardianship (including trusteeship),
References
Publications (1)
- DERIVEDRousseau C, Le Thiec M, Ferrer L, Rusu D, Rauscher A, Maucherat B, Frindel M, Baumgartner P, Fleury V, Denis A, Morel A, Varmenot N, Debeaupuis E, Campion L, Kraeber-Bodere F. Preliminary results of a 68 Ga-PSMA PET/CT prospective study in prostate cancer patients with occult recurrence: Diagnostic performance and impact on therapeutic decision-making. Prostate. 2019 Sep;79(13):1514-1522. doi: 10.1002/pros.23869. Epub 2019 Aug 17. PMID 31421657