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

March 16, 2023 updated by: Markus Zeitlinger, Medical University of Vienna

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: planned to undergo cytoreductive prostatectomy
Diagnostic test: liquid biopsies
circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients
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: liquid biopsies
circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients
Diagnostic test: FDHT-PET Scan
[18F]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET)
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: liquid biopsies
circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients
Diagnostic test: FDHT-PET Scan
[18F]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET)
Other: primary oligometastatic hormone-sensitive prostate cancer patients
who refuse to undergo cytoreductive radical prostatectomy will serve as control group
Diagnostic test: liquid biopsies
circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FDHT total receptor expression (TRE) volume parameters compared to clinical follow-up
Time Frame: through study completion, an average of 2 years
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
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
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
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
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
through study completion, an average of 2 years
CTC count before and after treatment
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years
ctDNA abundance before and after treatment
Time Frame: through study completion, an average of 2 years
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
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDHTProstate_Protocol_V3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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