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

Medical University of Vienna

Status: Withdrawn

Conditions: Prostate Cancer

Treatments: Diagnostic Test: liquid biopsies; Diagnostic Test: FDHT-PET Scan

Study type: Interventional

Funder types: Other

Identifiers

NCT05245435

FDHTProstate_Protocol_V3

Details and patient eligibility

About

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.

Sex: Male

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

planned to undergo cytoreductive prostatectomy

Other group

Description:

planned to undergo cytoreductive prostatectomy

Treatment:

Diagnostic Test: liquid biopsies

newly diagnosed metastatic hormone-sensitive prostate cancer patients

Other group

Description:

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

Treatment:

Diagnostic Test: liquid biopsies

Diagnostic Test: FDHT-PET Scan

metastatic castration-resistant prostate cancer patients

Other group

Description:

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

Treatment:

Diagnostic Test: liquid biopsies

Diagnostic Test: FDHT-PET Scan

primary oligometastatic hormone-sensitive prostate cancer patients

Other group

Description:

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

Treatment:

Diagnostic Test: liquid biopsies