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

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
primary oligometastatic hormone-sensitive prostate cancer patients	liquid biopsies	who refuse to undergo cytoreductive radical prostatectomy will serve as control group
planned to undergo cytoreductive prostatectomy	liquid biopsies	planned to undergo cytoreductive prostatectomy
newly diagnosed metastatic hormone-sensitive prostate cancer patients	liquid biopsies	planned to undergo androgen deprivation therapy, and/or treatment with abiraterone acetate, and/or enzalutamide and/or docetaxel
newly diagnosed metastatic hormone-sensitive prostate cancer patients	FDHT-PET Scan	planned to undergo androgen deprivation therapy, and/or treatment with abiraterone acetate, and/or enzalutamide and/or docetaxel
metastatic castration-resistant prostate cancer patients	FDHT-PET Scan	who were not pre-treated with enzalutamide or abiraterone acetate and planned treatment with those drugs
metastatic castration-resistant prostate cancer patients	liquid biopsies	who were not pre-treated with enzalutamide or abiraterone acetate and planned treatment with those drugs

Primary Outcome Measures

Name	Time	Method
ctDNA abundance before and after treatment	through study completion, an average of 2 years
(Quantitative) IHC analysis of androgen specific receptor expression levels (FDHT) in tissue	through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to clinical follow-up	through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to course of disease	through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to androgen resistance	through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to liquid biopsy parameters	through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to IHC patterns	through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to stage of disease	through study completion, an average of 2 years
CTC count before and after treatment	through study completion, an average of 2 years

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility