diagnostic and prognostic accuracy of fdht-pet and liquid biopsies in prostate cancer

Conditions: Prostate Cancer

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.


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