ECETEP : Pilot study evaluating PSMA positron emission tomography for monitoring clinically significant prostate cancer after focal HIFU treatment
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- presence of prostate cancer recurrence at 1-year follow-up detected by PSMA PET and confirmed by biopsies (gold standard).The sensitivity and specificity of PSMA PET will be estimated, as well as the positive predictive values.
研究概览
简要总结
The objective of this pilot study is to conduct an initial assessment of the diagnostic performance of PSMA PET/CT in diagnosing prostate cancer recurrence at 1-year follow-up in patients with favourable intermediate-risk localised prostate cancer treated with HIFU as a first-line curative therapy. The gold standard for diagnosis is biopsy at 1 year.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient with prostate cancer
- •Age ≥ 70 years
- •Life expectancy > 5 years
- •Clinical data - Clinical stage T1c – T2a - PSA < 20 ng/ml
- •Biopsy data - Unilateral ISUP 2 in a maximum of 2 contiguous sextants with or without ipsilateral or contralateral ISUP 1 focus - Single focus or multiple foci if only one ISUP 2 focus in the targeted biopsy
- •Imaging data - Single lesion - PIRADS 3 or 4 or 5 - Prostate volume < 150 ml
- •Affiliated with a social security scheme
- •Fair and informed consent signature
排除标准
- •Presence of signs of extraprostatic extension or invasion of the seminal vesicles
- •Patients deprived of their liberty or under legal protection (guardianship and trusteeship, judicial protection)
- •Any condition that, in the investigators' judgement, would interfere with the subject's ability to provide informed consent, comply with study instructions, expose the subject to increased risk, or interfere with the interpretation of study results
- •Hypersensitivity to the active substances or to any of the excipients of the investigational medicinal product 18F-PSMA
- •Contraindications to magnetic resonance imaging (MRI), such as the presence of internal metal devices
- •Chronic kidney disease with an eGFR ≤ 60 mL/min
- •Liver failure
结局指标
主要结局
presence of prostate cancer recurrence at 1-year follow-up detected by PSMA PET and confirmed by biopsies (gold standard).The sensitivity and specificity of PSMA PET will be estimated, as well as the positive predictive values.
presence of prostate cancer recurrence at 1-year follow-up detected by PSMA PET and confirmed by biopsies (gold standard).The sensitivity and specificity of PSMA PET will be estimated, as well as the positive predictive values.
次要结局
- presence of prostate cancer recurrence at 1-year follow-up detected by multiparametric MRI and confirmed by biopsies (gold standard)
- PSMA PET FALSE NEGATIVE RATE AT THE TIME OF DIAGNOSIS
- ESTIMATION OF THE DIAGNOSTIC PERFORMANCE OF THE PRIMARY SCORE
研究者
Dr Anne-Sophie BAJEOT
Scientific
Centre Hospitalier Universitaire De Toulouse