Diagnostic and Prognostic Accuracy of FDHT-PET and Liquid Biopsies in Prostate Cancer
Prostate Cancer
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Other
Other
Other
planned to undergo cytoreductive prostatectomy
newly diagnosed metastatic hormone-sensitive prostate cancer patients
metastatic castration-resistant prostate cancer patients
primary oligometastatic hormone-sensitive prostate cancer patients
planned to undergo cytoreductive prostatectomy
planned to undergo androgen deprivation therapy, and/or treatment with abiraterone acetate, and/or enzalutamide and/or docetaxel
who were not pre-treated with enzalutamide or abiraterone acetate and planned treatment with those drugs
who refuse to undergo cytoreductive radical prostatectomy will serve as control group