WithdrawnNCT05245435Updated Mar 20, 2023

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

An interventional study of FDHT-PET Scan and liquid biopsies in Prostate Cancer, sponsored by Medical University of Vienna. Withdrawn at 1 site in Austria. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-20.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn

Recruitment was not possible with the chosen inclusion/exclusion criteria at our Institution.

Phase: Not applicable
Study type: Interventional
Enrollment: 0
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: Male

Study 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.

Conditions studied

Prostate Cancer

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Prostatic Neoplasms 6,370

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

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Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: Male
Accepts 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

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

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 0 participants (actual)

Study arms

Other
planned to undergo cytoreductive prostatectomy
planned to undergo cytoreductive prostatectomy
Diagnostic Test: liquid biopsies
Other
newly diagnosed metastatic hormone-sensitive prostate cancer patients
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
Other
metastatic castration-resistant prostate cancer patients
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
Other
primary oligometastatic hormone-sensitive prostate cancer patients
who refuse to undergo cytoreductive radical prostatectomy will serve as control group
Diagnostic Test: liquid biopsies

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

What researchers measure

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

Study locations

1 site

Medical University of Vienna
Vienna, 1090, Austria

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05245435
Lead sponsor: Medical University of Vienna
Responsible party: Markus Zeitlinger (Principal Investigator, Medical University of Vienna) — Principal investigator
First posted: Feb 18, 2022
Start date: Apr 2022 (estimated)
Primary completion: Sep 2024 (estimated)
Completion: Sep 2024 (estimated)
Last update: Mar 20, 2023

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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