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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05245435
• Other study ID #: FDHTProstate_Protocol_V3
• Status: Withdrawn
• Phase: N/A
• Start date: April 2022
• Est. completion date: September 2024

Study information

• Verified date: March 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• FDHT-PET Scan
[18F]-fluoro-5a-dihydrotestosterone (FDHT)- positron emission tomography (PET)
• liquid biopsies
circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FDHT total receptor expression (TRE) volume parameters compared to clinical follow-up		through study completion, an average of 2 years
Primary	FDHT total receptor expression (TRE) volume parameters compared to course of disease		through study completion, an average of 2 years
Primary	FDHT total receptor expression (TRE) volume parameters compared to androgen resistance		through study completion, an average of 2 years
Primary	FDHT total receptor expression (TRE) volume parameters compared to liquid biopsy parameters		through study completion, an average of 2 years
Primary	FDHT total receptor expression (TRE) volume parameters compared to IHC patterns		through study completion, an average of 2 years
Primary	FDHT total receptor expression (TRE) volume parameters compared to stage of disease		through study completion, an average of 2 years
Primary	CTC count before and after treatment		through study completion, an average of 2 years
Primary	ctDNA abundance before and after treatment		through study completion, an average of 2 years
Primary	(Quantitative) IHC analysis of androgen specific receptor expression levels (FDHT) in tissue		through study completion, an average of 2 years