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

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

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.

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