Diagnostic and Prognostic Accuracy of FDHT-PET and Liquid... | NCT05245435

NCT05245435

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FDHT-PET Scan	Diagnostic Test	[18F]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET)	metastatic castration-resistant prostate cancer patients

Outcomes Module

Primary Outcomes

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

Eligibility Module

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

ID	Term
D001706	Biopsy
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques