Evaluation of Fapi-pet in Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Positive predictive value on a lesion level
研究概览
简要总结
The investigators explore the biodistribution of FAPI-PET expression in primary high-risk prostate cancer in men undergoing RALP and eLND and in men with metastatic PCa about to start next generation antiandrogen.
详细描述
This is an exploratory cohort study comprised of men with clinically localized or locally advanced high-risk prostate cancer (GG 3-5, cT2-cT3, Nx, M0) managed by RALP and eLND and men with metastatic (mHSPC or mCRPC) prostate cancer scheduled to start NHT along clinical care pathway (e.g., apalutamide, enzalutamide) at HUS Helsinki University Hospital and Helsinki University, Finland.
Men identified along routine clinical care as candidates for the study will be asked to consent.
Once consented, patients will undergo PSMA-PET imaging instead of conventional imaging (CT and bone scan) and experimental FAPI-PET imaging. Furthermore, biomarker samples will be obtained before and after treatment (surgery or novel antiandrogen) and surgical specimen will be processed for routine pathological evaluation and multiplex IHC studies. Serum samples will be tested for PCa biomarkers (e.g., PSA, NSE, CgA) and cfDNA. Urine will be processed and extracellular vesicles (exosomes) isolated and markers of reactive stroma will be sought for.
Radical prostatectomy and novel hormonal treatment will be done according to current recommendations and guidelines in Finland.
Postoperatively, patients will be followed with PSA every six months. Biochemical recurrence will be set at PSA of 0.2 ug/l or higher.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men scheduled for radical prostatectomy
- •Age over 18 years
- •GG 3-5, cT2-cT3, Nx, M0 prostate cancer
- •no contraindication to PSMA - or FAPI-PET
- •willing to undergo study related procedures (imaging and laboratory tests) Men scheduled for novel antiandrogen
- •Age over 18 years
- •GG2-5, cT2-4, N0-1, M1
- •hormone sensitive or castration resistant prostate cancer
排除标准
- •Not willing or capable to undergo study related procedures
结局指标
主要结局
Positive predictive value on a lesion level
时间窗: through study completion, an average of 1 year
Positive predictive value of FAPI-PET on a lesion level using histopathology or confirmatory imaging as ground truth
次要结局
- Positive predictive value on a patient level(through study completion, an average of 1 year)
- To assess the biodistribution of FAPI and PSMA PET signal in comparison to histology(through study completion, an average of 1 year)
- To assess the biodistribution of FAPI and PSMA PET signal in comparison to biomarkers in "wet" samples(through study completion, an average of 1 year)
- To assess the biodistribution of FAPI PET signal in comparison to PSMA-PET signal(through study completion, an average of 1 year)
- To assess the biodistribution of FAPI and PSMA PET signal in comparison to immunohistochemistry(through study completion, an average of 1 year)
研究者
Antti Rannikko
Assistant professor
Helsinki University Central Hospital