Prostate Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTFDHT-PET Scan
\[18F\]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET)
DIAGNOSTIC_TESTliquid biopsies
circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients
Sponsors
Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
Austria
Outcome results
None listed