Diagnostic and Prognostic Accuracy of FDHT-PET and Liquid Biopsies in Prostate Cancer

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.


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