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

Sponsor

Medical University of Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT05245435

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Diagnostic Test: FDHT-PET Scan Diagnostic Test: liquid biopsies	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: planned to undergo cytoreductive prostatectomy 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: FDHT-PET Scan [18F]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET) Diagnostic Test: liquid biopsies circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients
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 [18F]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET) Diagnostic Test: liquid biopsies circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients
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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Markus Zeitlinger, Principal Investigator, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT05245435

Other Study ID Numbers:

FDHTProstate_Protocol_V3

First Posted:

Feb 18, 2022

Last Update Posted:

Feb 18, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Feb 18, 2022