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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: FDHT-PET Scan
* Diagnostic Test: liquid biopsies


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: planned to undergo cytoreductive prostatectomy<br>planned to undergo cytoreductive prostatectomy | Diagnostic Test: liquid biopsies<br>* circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients<br>|
| Other: newly diagnosed metastatic hormone-sensitive prostate cancer patients<br>planned to undergo androgen deprivation therapy, and/or treatment with abiraterone acetate, and/or enzalutamide and/or docetaxel | Diagnostic Test: FDHT-PET Scan<br>* [18F]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET)<br>Diagnostic Test: liquid biopsies<br>* circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients<br>|
| Other: metastatic castration-resistant prostate cancer patients<br>who were not pre-treated with enzalutamide or abiraterone acetate and planned treatment with those drugs | Diagnostic Test: FDHT-PET Scan<br>* [18F]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET)<br>Diagnostic Test: liquid biopsies<br>* circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients<br>|
| Other: primary oligometastatic hormone-sensitive prostate cancer patients<br>who refuse to undergo cytoreductive radical prostatectomy will serve as control group | Diagnostic Test: liquid biopsies<br>* circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |