Status:
WITHDRAWN
Diagnostic and Prognostic Accuracy of FDHT-PET and Liquid Biopsies in Prostate Cancer
Lead Sponsor:
Medical University of Vienna
Conditions:
Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
NA
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/...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05245435
Start Date
April 1 2022
End Date
September 1 2024
Last Update
March 20 2023
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090