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

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
FDHT-PET Scan
liquid biopsies
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

planned to undergo cytoreductive prostatectomy

newly diagnosed metastatic hormone-sensitive prostate cancer patients

metastatic castration-resistant prostate cancer patients

primary oligometastatic hormone-sensitive prostate cancer patients

Arm Description

planned to undergo cytoreductive prostatectomy

planned to undergo androgen deprivation therapy, and/or treatment with abiraterone acetate, and/or enzalutamide and/or docetaxel

who were not pre-treated with enzalutamide or abiraterone acetate and planned treatment with those drugs

who refuse to undergo cytoreductive radical prostatectomy will serve as control group

Outcomes

Primary Outcome Measures

FDHT total receptor expression (TRE) volume parameters compared to clinical follow-up
FDHT total receptor expression (TRE) volume parameters compared to course of disease
FDHT total receptor expression (TRE) volume parameters compared to androgen resistance
FDHT total receptor expression (TRE) volume parameters compared to liquid biopsy parameters
FDHT total receptor expression (TRE) volume parameters compared to IHC patterns
FDHT total receptor expression (TRE) volume parameters compared to stage of disease
CTC count before and after treatment
ctDNA abundance before and after treatment
(Quantitative) IHC analysis of androgen specific receptor expression levels (FDHT) in tissue

Secondary Outcome Measures

Full Information

First Posted
September 28, 2021
Last Updated
March 16, 2023
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT05245435
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment was not possible with the chosen inclusion/exclusion criteria at our Institution.
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
planned to undergo cytoreductive prostatectomy
Arm Type
Other
Arm Description
planned to undergo cytoreductive prostatectomy
Arm Title
newly diagnosed metastatic hormone-sensitive prostate cancer patients
Arm Type
Other
Arm Description
planned to undergo androgen deprivation therapy, and/or treatment with abiraterone acetate, and/or enzalutamide and/or docetaxel
Arm Title
metastatic castration-resistant prostate cancer patients
Arm Type
Other
Arm Description
who were not pre-treated with enzalutamide or abiraterone acetate and planned treatment with those drugs
Arm Title
primary oligometastatic hormone-sensitive prostate cancer patients
Arm Type
Other
Arm Description
who refuse to undergo cytoreductive radical prostatectomy will serve as control group
Intervention Type
Diagnostic Test
Intervention Name(s)
FDHT-PET Scan
Intervention Description
[18F]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET)
Intervention Type
Diagnostic Test
Intervention Name(s)
liquid biopsies
Intervention Description
circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients
Primary Outcome Measure Information:
Title
FDHT total receptor expression (TRE) volume parameters compared to clinical follow-up
Time Frame
through study completion, an average of 2 years
Title
FDHT total receptor expression (TRE) volume parameters compared to course of disease
Time Frame
through study completion, an average of 2 years
Title
FDHT total receptor expression (TRE) volume parameters compared to androgen resistance
Time Frame
through study completion, an average of 2 years
Title
FDHT total receptor expression (TRE) volume parameters compared to liquid biopsy parameters
Time Frame
through study completion, an average of 2 years
Title
FDHT total receptor expression (TRE) volume parameters compared to IHC patterns
Time Frame
through study completion, an average of 2 years
Title
FDHT total receptor expression (TRE) volume parameters compared to stage of disease
Time Frame
through study completion, an average of 2 years
Title
CTC count before and after treatment
Time Frame
through study completion, an average of 2 years
Title
ctDNA abundance before and after treatment
Time Frame
through study completion, an average of 2 years
Title
(Quantitative) IHC analysis of androgen specific receptor expression levels (FDHT) in tissue
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

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

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