Diagnostic and Prognostic Accuracy of FDHT-PET and Liquid Biopsies in Prostate Cancer
Not Applicable
Withdrawn
- Conditions
- Prostate Cancer
- Registration Number
- NCT05245435
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
COHORT A:
- 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
COHORT B:
- 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 0-2.
- 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 C:
- 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 0-2.
- 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
Exclusion Criteria
COHORT A:
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method ctDNA abundance before and after treatment through study completion, an average of 2 years (Quantitative) IHC analysis of androgen specific receptor expression levels (FDHT) in tissue through study completion, an average of 2 years FDHT total receptor expression (TRE) volume parameters compared to clinical follow-up through study completion, an average of 2 years FDHT total receptor expression (TRE) volume parameters compared to course of disease through study completion, an average of 2 years FDHT total receptor expression (TRE) volume parameters compared to androgen resistance through study completion, an average of 2 years FDHT total receptor expression (TRE) volume parameters compared to liquid biopsy parameters through study completion, an average of 2 years FDHT total receptor expression (TRE) volume parameters compared to IHC patterns through study completion, an average of 2 years FDHT total receptor expression (TRE) volume parameters compared to stage of disease through study completion, an average of 2 years CTC count before and after treatment through study completion, an average of 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria
Medical University of Vienna🇦🇹Vienna, Austria