Diagnostic and Prognostic Accuracy and Health Economics Considerations of [18F]-Fluoro-5α-dihydrotestosterone (FDHT)- Positron Emission Tomography (PET) and Circulating Tumor Cells - a Pilot Study in Patients Undergoing Cytoreductive Prostatectomy in the Setting of Primary Oligometastatic Prostate Cancer, in Patients With Primary Metastatic Hormone-sensitive Prostate Cancer, and in Patients With Metastatic Castration Resistant Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- FDHT total receptor expression (TRE) volume parameters compared to androgen resistance
研究概览
简要总结
Depending on the cohort of the study the diagnostic and prognostic accuracy and health economics considerations of [18F]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET) and/or circulating tumor cells in prostate cancer patients are studied.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Histologically confirmed oligometastatic adenocarcinoma of the prostate (defined as ≤5 metastases in lymph node (LN) or bone)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1
- •Planned cytoreductive radical prostatectomy
- •≤ 5 osseous and/or lymph node 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, questionnaire completion and other study procedures
- •Age 18-75 years
- •Histologically confirmed oligometastatic adenocarcinoma of the prostate
- •Newly diagnosed metastatic hormone-sensitive disease
- •planned therapy with androgen deprivation therapy, and/or treatment with abiraterone acetate, and/or enzalutamide and/or docetaxel
- •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, questionnaire completion and other study procedures
- •Age 18-75 years
- •Histologically confirmed oligometastatic adenocarcinoma of the prostate
- •Metastatic castration-resistant disease
- •Not pre-treated with enzalutamide or abiraterone acetate
- •Planned therapy with abiraterone acetate, or enzalutamide
- •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, questionnaire completion and other study procedures
- •COHORT D (control group for Cohort A):
- •Age 18-75 years
- •Histologically confirmed oligometastatic adenocarcinoma of the prostate (defined as ≤5 metastases in lymph node (LN) or bone)
- •Hormone-sensitive prostate cancer
- •Refused cytoreductive 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, questionnaire completion and other study procedures
排除标准
- •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
- •Patient's not eligible for the size of the PET/MRI gantry
- •COHORTS B and C:
- •HIV positive
- •Any contraindication for tissue biopsy (if tissue biopsy 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
- •Patient's not eligible for the size of the PET/MRI gantry
- •COHORT D (control group for Cohort A):
- •HIV positive
- •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
- •Patient's not eligible for the size of the PET/MRI gantry
研究组 & 干预措施
planned to undergo cytoreductive prostatectomy
planned to undergo cytoreductive prostatectomy
干预措施: liquid biopsies (Diagnostic Test)
newly diagnosed metastatic hormone-sensitive prostate cancer patients
planned to undergo androgen deprivation therapy, and/or treatment with abiraterone acetate, and/or enzalutamide and/or docetaxel
干预措施: FDHT-PET Scan (Diagnostic Test)
newly diagnosed metastatic hormone-sensitive prostate cancer patients
planned to undergo androgen deprivation therapy, and/or treatment with abiraterone acetate, and/or enzalutamide and/or docetaxel
干预措施: liquid biopsies (Diagnostic Test)
metastatic castration-resistant prostate cancer patients
who were not pre-treated with enzalutamide or abiraterone acetate and planned treatment with those drugs
干预措施: FDHT-PET Scan (Diagnostic Test)
metastatic castration-resistant prostate cancer patients
who were not pre-treated with enzalutamide or abiraterone acetate and planned treatment with those drugs
干预措施: liquid biopsies (Diagnostic Test)
primary oligometastatic hormone-sensitive prostate cancer patients
who refuse to undergo cytoreductive radical prostatectomy will serve as control group
干预措施: liquid biopsies (Diagnostic Test)
结局指标
主要结局
FDHT total receptor expression (TRE) volume parameters compared to androgen resistance
时间窗: through study completion, an average of 2 years
ctDNA abundance before and after treatment
时间窗: through study completion, an average of 2 years
(Quantitative) IHC analysis of androgen specific receptor expression levels (FDHT) in tissue
时间窗: through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to clinical follow-up
时间窗: through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to course of disease
时间窗: through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to liquid biopsy parameters
时间窗: through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to IHC patterns
时间窗: through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to stage of disease
时间窗: through study completion, an average of 2 years
CTC count before and after treatment
时间窗: through study completion, an average of 2 years
次要结局
未报告次要终点
研究者
Markus Zeitlinger
Principal Investigator
Medical University of Vienna