Diagnostic Multicenter Phase II Study, Prospective, Comparative, of 68Ga-HBED-PSMA PET / CT and Conventional Imaging Procedures in Occult Biological Relapse Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- added value of 68Ga-HBED-CC-PSMA PET / CT in imaging examinations in terms of detection sensitivity of recurrence sites
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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),
结局指标
主要结局
added value of 68Ga-HBED-CC-PSMA PET / CT in imaging examinations in terms of detection sensitivity of recurrence sites
时间窗: 6 months
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".
次要结局
未报告次要终点