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

NCT05245435 | Withdrawn

• 1 other identifier: FDHTProstate_Protocol_V3
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (4)

planned to undergo cytoreductive prostatectomy

OTHER

planned to undergo cytoreductive prostatectomy

Diagnostic Test: liquid biopsies

newly diagnosed metastatic hormone-sensitive prostate cancer patients

OTHER

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

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

metastatic castration-resistant prostate cancer patients

OTHER

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

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

primary oligometastatic hormone-sensitive prostate cancer patients

OTHER

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

Diagnostic Test: liquid biopsies

Interventions

FDHT-PET Scan DIAGNOSTIC_TEST

\[18F\]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET)

metastatic castration-resistant prostate cancer patients; newly diagnosed metastatic hormone-sensitive prostate cancer patients

liquid biopsies DIAGNOSTIC_TEST

circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients

metastatic castration-resistant prostate cancer patients; newly diagnosed metastatic hormone-sensitive prostate cancer patients; planned to undergo cytoreductive prostatectomy; primary oligometastatic hormone-sensitive prostate cancer patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: February 18, 2022
• Study Start: April 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)