NCT05109884已完成不适用
Comparison of PET Imaging Patterns With Prostate-specific Membrane Antigen and Androgen Specific Receptor Expression Patterns in Prostate Cancer and Bladder Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Correlation of PET imaging parameters with PSMA and AR expression levels
研究概览
简要总结
Patients suffering either from newly diagnosed very high risk locally advanced and/or oligometastatic prostate cancer (cohort A), metastatic castration-resistant prostate cancer (mCRPC, cohort B), newly diagnosed postate cancer with planned radical prostatectomy (cohort C) or primary bladder cancer with planned radical cystectomy (cohort D) as identified by a multidisciplinary team of specialists, will be included.
PET imaging patterns using PSMA- and FDHT PET scans will be correlated with prostate-specific membrane antigen and androgen specific receptor expression patterns in prostate cancer and bladder cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Histologically or cytologically confirmed adenocarcinoma of the prostate with very high risk for the development of metastases (defined as PSA ≥20 or Gleason Score ≥8 or ≥cT3) and/or oligometastatic (T any, N positive, M any or T any, N any, M positive)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1
- •Planned radical prostatectomy
- •≤ 5 osseous metastasis
- •Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study participation
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, and other study procedures
- •Cohort B - mCRPC:
- •Age ≥ 18 years
- •Histologically or cytologically confirmed prostate adenocarcinoma.
- •Presence of skeletal or nodal metastases according to one of the following criteria:
- •Confirmed pathological fracture related to the disease OR
- •Confirmation of distant bone and/or nodal metastases on CT or MRI scan or bone scintigraphy.
- •Positive pathology report of metastatic lesion.
- •Disease progression despite ADT as indicated by:
- •PSA increase that is ≥ 2 ng/mL and ≥ 25% above the minimum PSA as reached during ADT or above the pre-treatment level, if no response was observed and which is confirmed by a second value 1 or more weeks later.
- •Progression of measurable lymph nodes (short axis ≥ 15 mm) or visceral lesion measurable per RECIST OR
- •New metastatic lesions appearing on bone scan/imaging
- •Chemical or surgical castration
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0-
- •Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study participation
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, and other study procedures
- •Age ≥ 18 years
- •Histologically or cytologically confirmed prostate adenocarcinoma.
- •Planned radical prostatectomy
- •Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study participation
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, and other study procedures
- •Age ≥ 18 years
- •Histologically or cytologically confirmed bladder cancer.
- •Planned radical cystectomy
- •Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study participation
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, and other study procedures
排除标准
- •Tumour infiltration of the rectum or pelvic wall
- •Visceral metastasis
- •HIV positive
- •Any contraindication for surgery
- •Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures.
- •Any contraindication for performing a PET/MRI scan (if applicable)
- •Patient's not eligible for the size of the PET/MRI gantry
- •Cohort B - mCRPC:
- •HIV positive
- •Any contraindication for tissue biopsy (if tissue biopsy is planned)
- •Any contraindication for surgery (if surgery is planned)
- •Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures.
- •Any contraindication for performing a PET/MRI scan (if applicable)
- •Patient's not eligible for the size of the PET/MRI gantry
- •Any contraindication for surgery
- •Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures.
- •Any contraindication for performing a PET/MRI scan (if applicable)
- •Patient's not eligible for the size of the PET/MRI gantry
- •Any contraindication for surgery
- •Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures.
- •Any contraindication for performing a PET/MRI scan (if applicable)
- •Patient's not eligible for the size of the PET/MRI gantry
结局指标
主要结局
Correlation of PET imaging parameters with PSMA and AR expression levels
时间窗: through study completion, an average of 3 years
To correlate PET imaging parameters with prostate-specific membrane antigen (PSMA), and androgen specific receptor expression levels in tissue biopsy samples using immuno-histochemical methods (IHC).
次要结局
未报告次要终点
研究者
Markus Zeitlinger
Principal Investigator
Medical University of Vienna
研究点 (2)
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