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

N/AWithdrawnNCT05245435
Medical University of Vienna

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Prostate Cancer

Interventions

FDHT-PET ScanDIAGNOSTIC_TEST

\[18F\]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET)

liquid biopsiesDIAGNOSTIC_TEST

circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years
Medical Language ↔ Plain English
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

Locations (1)

Medical University of Vienna

Vienna, Austria

Outcomes

Primary Outcomes

FDHT total receptor expression (TRE) volume parameters compared to clinical follow-up

Time frame: through study completion, an average of 2 years

FDHT total receptor expression (TRE) volume parameters compared to course of disease

Time frame: through study completion, an average of 2 years

FDHT total receptor expression (TRE) volume parameters compared to androgen resistance

Time frame: through study completion, an average of 2 years

FDHT total receptor expression (TRE) volume parameters compared to liquid biopsy parameters

Time frame: through study completion, an average of 2 years

FDHT total receptor expression (TRE) volume parameters compared to IHC patterns

Time frame: through study completion, an average of 2 years

FDHT total receptor expression (TRE) volume parameters compared to stage of disease

Time frame: through study completion, an average of 2 years

CTC count before and after treatment

Time frame: through study completion, an average of 2 years

ctDNA abundance before and after treatment

Time frame: through study completion, an average of 2 years

(Quantitative) IHC analysis of androgen specific receptor expression levels (FDHT) in tissue

Time frame: through study completion, an average of 2 years

Data from ClinicalTrials.gov

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