Clinical trial NCT05245435: Diagnostic and Prognostic Accuracy of FDHT-PET and Liquid Biopsies in Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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

Primary outcomes:
measure: FDHT total receptor expression (TRE) volume parameters compared to clinical follow-up
timeFrame: through study completion, an average of 2 years
measure: FDHT total receptor expression (TRE) volume parameters compared to course of disease
timeFrame: through study completion, an average of 2 years
measure: FDHT total receptor expression (TRE) volume parameters compared to androgen resistance
timeFrame: through study completion, an average of 2 years
measure: FDHT total receptor expression (TRE) volume parameters compared to liquid biopsy parameters
timeFrame: through study completion, an average of 2 years
measure: FDHT total receptor expression (TRE) volume parameters compared to IHC patterns
timeFrame: through study completion, an average of 2 years
measure: FDHT total receptor expression (TRE) volume parameters compared to stage of disease
timeFrame: through study completion, an average of 2 years
measure: CTC count before and after treatment
timeFrame: through study completion, an average of 2 years
measure: ctDNA abundance before and after treatment
timeFrame: through study completion, an average of 2 years
measure: (Quantitative) IHC analysis of androgen specific receptor expression levels (FDHT) in tissue
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: