COMBINED PSMA-PET/CT AND MRI STAGING IN INTERMEDIATE AND HIGH-RISK PATIENTS PROSTATA-CANCER (COMBINE-P) - A Multicentre Retrospective Analysis in the European Prostate Cancer Centres of Excellence for Prostate Cancer (EPCCE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
- 试验地点
- 10
- 主要终点
- The primary outcome includes the correct LN-staging after radical prostatectomy with the use of PSMA-PET-CT with different tracers and mpMRI in patients with significant prostate cancer (ISUP grade group ≥ 2) of intermediate- or high-risk group
研究概览
简要总结
This retrospective, multicentre comparative analysis aims to evaluate a new staging method for i) improved detection of intraprostatic index lesions, ii) local T-staging and iii) lymph node (LN) staging in men with clinically significant prostate cancer (csPCa) at intermediate/high risk by combining prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging using different tracers ((18)F) DCFPyL, Gallium-68, Fluor-18) and multiparametric magnetic resonance imaging (MRI) in patients with prostate cancer (PCa) who subsequently underwent radical prostatectomy (RP). Another secondary endpoint will be the additional value of PSMA-PET/CT in men with unremarkable MRI. Men at intermediate risk (PSA > 10 ng/ml to 20 ng/ml or Gleason score 7 or cT category 2b) or high risk (PSA > 20 ng/ml or Gleason score ≥ 8 or cT category 2c) who underwent PSMA-PET/CT and mpMRI followed by RP will be analysed in three different subgroups corresponding to the modalities i) PSMA-PET/CT with 18-F-DCFPyL (subgroup/arm A), ii) Gallium-68 PSMA-PET/CT (subgroup/arm B) and Fluorine-18 PSMA-PET/CT (subgroup/arm C).
The validation of the accuracy of the detection of intraprostatic index lesions, local and lymph node staging by MRI and PSMA-PET-CT with different tracers is carried out using the histological radical prostatectomy specimens.
In addition, the prediction of the International Society of Urolgenital Pathology (ISUP) graduation group (GG) within intraprostatic index lesions will be determined using the SUV (standardised uptake value) in PSMA-PET-CT and using ADC values (Apparent Diffusion Coefficient of the diffusion-weighted MRI sequence) in MRI (7,8). The ability of PSMA-PET-CT to predict extraprostatic, i.e. capsule-transcending, tumour growth is also analysed in comparison with MRI. In addition, the correlation of tumour localisation (right vs. left) in relation to positive lymph nodes (right vs. left) is analysed. Finally, the added value of PSMAPET-CT in the case of negative, unsuspicious MRI is determined.
Overall, our analysis aims to improve patient care by analysing the potential of non-invasive "digital biopsy" in terms of lesion detection and prediction of the histological grading group.
In addition, a proof-of-concept for personalised lymph node dissection based on prediction of lymph node metastasis and patient-tailored nerve sparing with accurate prediction of extracapsular extension will be tested based on combined preoperative PSMA-PET and MRI imaging. The results of these two analyses will have a direct impact on clinical practice and the further use of highly specialised imaging.
In addition, this multi-centre data analysis will provide the European Prostate Cancer Center of Excellence (EPCCE) group with a proof-of-concept for future projects.
详细描述
Study protocol - COMBINE-P
- Please enter a meaningful study title that describes the project at hand
COMBINED PSMA-PET/CT AND MRI STAGING IN INTERMEDIATE AND HIGH-RISK PATIENTS PROSTATA-CANCER (COMBINE-P) - A multicentre retrospective analysis in the European Prostate Cancer Centres of Excellence for Prostate Cancer (EPCCE) 2. Name and title of the study coordinators, degree/ profession, institute/ clinic
Prof. Dr Jan Philipp Radtke, Deputy Director and Senior Consultant, Department of Urology, Düsseldorf University Hospital Prof. Dr Peter Albers, Clinic Director, Clinic for Urology, Düsseldorf University Hospital Dr Isabelle Busshoff, Assistant Physician, Department of Urology, Düsseldorf University Hospital
2.1 Study Site Coordinators, degree/ profession, institute/ clinic 2.1.1 Germany - University Hospital Munich - Ludwigs-Maximilian-University Munich Prof. Dr Christian Stief, Full Professor of Urology and Chairman, Department of Urology Dr Thilo Westhofen, Consultant, Department of Urology 2.1.2 Germany - University Hospital Tübingen Prof. Dr Arnulf Stenzl, Professor of Urology and Chairman, Department of Urology Prof. Dr Steffen Rausch, Professor of Urology, Department of Urology, University Hospital Tübingen 2.1.3 Germany - University Hospital Bochum Prof. Dr Joachim Nodus, Full Professor of Urology, Marien Hospital Herne University of Ruhr-University Bochum Prof. Dr Florian Roghmann, Professor of Urology, Marien Hospital Herne University of Ruhr-University Bochum 2.1.4 Germany - University Hospital Düsseldorf Prof. Dr Lars Schimmöller, Institute of Diagnostic and Interventional Radiology Prof. Dr Frederik L. Giesel, Department of Nuclear Medicine 2.1.5 United Kingdom - Christie Clinic Foundation Trust Manchaster Prof. Dr Vijay Sangar, Full Professor of Urology, Department of Urology 2.1.6 Belgium - University Hospital Leuven Prof. Dr Steven Joniau, Full Professor of Urology, Department of Urology Prof. Dr Karolien Goffin, Full Professor of Nuclear Medicine , Department of Nuclear Medicine 2.1.7 France - Hospital Civils de Lyon Prof. Dr Alain Ruffion, Full Professor of Urology, Department of Urology 2.1.8 Switzerland - University Hospital Bern Prof. Dr George Thalmann, Professor of Urology, Department of Urology 2.1.9 Italy - Hospital IRCCS San Raffaele Milan Prof. Dr Francesco Montorsi, Full Professor of Urology, Department of Urology Prof. Dr Alberto Briganti, Professor of Urology, Department of Urology Dr Armando Stabile, Consultant, Department of Urology 2.1.10 Austria - University Hospital Vienna Prof. Dr Shahrokh Shariat, Full Professor of Urology, Department of Urology Dr Pawel Rajwa, Consultant, Department of Urology 2.1.11 Sweden - Lund University, Skane University Hospital Prof. Dr Anders Bjartell, Professor of Urology, Department of Urology
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged from 45 to 80 years
- •Men with intermediate risk or high risk csPCa
- •Men who underwent RP
- •Men who underwent multiparametric MRI and PSMA-PET/CT before RP
排除标准
- •a) Men with known prostate cancer, who did not underwent RP and who did not underwent MRI or PSMA-PET-CT
研究组 & 干预措施
Patients staged with PSMA-PET/CT of several tracers prior to Radical Prostatectomy
Men at intermediate risk (PSA > 10 ng/ml to 20 ng/ml or Gleason score 7 or cT category 2b) or high risk (PSA > 20 ng/ml or Gleason score ≥ 8 or cT category 2c) who underwent PSMA-PET/CT and mpMRI followed by RP will be analysed in three different subgroups corresponding to the modalities i) PSMA-PET/CT with 18-F-DCFPyL (subgroup/arm A), ii) Gallium-68 PSMA-PET/CT (subgroup/arm B) and Fluorine-18 PSMA-PET/CT (subgroup/arm C)
干预措施: PSMA-11 (Diagnostic Test)
结局指标
主要结局
The primary outcome includes the correct LN-staging after radical prostatectomy with the use of PSMA-PET-CT with different tracers and mpMRI in patients with significant prostate cancer (ISUP grade group ≥ 2) of intermediate- or high-risk group
时间窗: 01.01.2026-31.12.2026
The primary outcome includes the correct LN-staging after radical prostatectomy with the use of PSMA-PET-CT with different tracers and mpMRI in patients with significant prostate cancer (ISUP grade group ≥ 2) of intermediate- or high-risk group
次要结局
- • ISUP GG prediction by SUV (standardized uptake value) and ADC (apparent diffusion coefficient) values on mpMRI(01.12.2026-31.12.2026)
- Extraprostatic disease(01.12.2026-31.12.2026)
- Significant prostate cancer detection by one modality(01.12.2026-31.12.2026)