Exploratory, Single-institution Study, Comparing 68Ga-RM2 PET/CT Versus 68Ga-PSMA-617 PET/CT in Patients Diagnosed With Prostate Cancer of Various Metastatic Risks Candidates for Radical Prostatectomy - "UROPET"
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Median Standardized Uptake Value (SUV)
研究概览
简要总结
Patients with primary prostate cancer (low, intermediate or high metastatic risk) for whom radical prostatectomy is indicated, will be invited to participate to the present study.
Positron Emission Tomography coupled with scanner (PET-CT) using a radiotracer : 68Ga-RM2 and Positron Emission Tomography coupled with scanner (PET-CT) using another radiotracer : 68Ga-PSMA-617, will be scheduled.
详细描述
Approximately 15% of men with prostate cancer have high-risk disease at diagnosis. For these patients the accuracy of initial staging is of critical importance for treatment decision-making.
Recommended imaging modalities for initial staging include computerized tomography (CT) scan, bone scan, and Magnetic Resonance Imaging (MRI). In addition to initial work-up, 18F-Choline Positron Emission Tomography coupled with scanner (PET-CT) may be proposed in some high-risk patients but its sensitivity for lymph node detection remains limited.
Nowadays, new radiotracers are becoming available for prostate cancer imaging. Among them, PET-CT imaging with radiolabeled ligands of prostate specific membrane antigen (PSMA) could be more sensitive and more specific for the detection of lymph node metastasis in high-risk cancers, as it is the case with radiolabeled PSMA-617 which has demonstrated very promising results in men with metastatic prostate cancer in recent studies.
Therefore, PET imaging with 68Ga-PSMA-617 may participate to optimize work-up in the staging of high-risk patients.
Another family of radiopharmaceuticals aimed to target the Gastrin-Releasing Peptide Receptor (GRP-R) which is overexpressed in low-grade prostatic carcinomas. GRP-R expression is correlated with androgen receptor expression and with better outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •24 patients divided in :
- •6 patients with low risk prostate cancer (Gleason score ≤ 6 and cT1-T2a and Prostate Specific Antigen (PSA) value < 10 ng/mL)
- •12 patients with intermediate risk prostate cancer (Gleason score 7 or cT2b or PSA value 10-20 ng/mL) divided in : 6 patients who are Gleason score 7(3+4) (favourable intermediate risk) 6 patients who are Gleason score 7(4+3) (unfavourable intermediate risk)
- •6 patients with high risk prostate cancer (Gleason > 7 or cT2c or PSA value > 20 ng/mL)
- •Candidate for radical prostatectomy after discussion in multidisciplinary committee
- •Covered by the national health insurance system
- •Written informed consent willingly obtained
排除标准
- •any kind of previous treatment for prostate cancer (hormonal treatment, EBRT, brachytherapy, cryotherapy, etc…);
- •patient not candidate for radical prostatectomy and/or unable to benefit from surgery
- •freedom deprivated patient by judiciary or administrative decision
- •patient under legal protection or unable to express its own consent
- •patient within exclusion period from another clinical trial
- •known contraindication to radiopharmaceuticals and / or excipients
研究组 & 干预措施
PET/CT Imaging
干预措施: 68Ga-PSMA-617 PET/CT (Drug)
PET/CT Imaging
干预措施: 68Ga-RM2 PET/CT (Drug)
结局指标
主要结局
Median Standardized Uptake Value (SUV)
时间窗: Day 0 (inclusion) or Day 2 to 21 (Visit 2)
Median Standardized Uptake Value (SUV) of 68Ga-PSMA-617
次要结局
- Immunoreactive score (IRS)(Day 3 to 60 (Last visit))
- Gleason score(Day 3 to 60 (Last visit))
- Local radioactive concentration (cpm)(Day 0 (inclusion) or Day 2 to 21 (Visit 2))
- Receptor density Bmax(Day 0 (inclusion) or Day 2 to 21 (Visit 2))