Clinical trial · Interventional
Diagnostic and Prognostic Accuracy of FDHT-PET and Liquid Biopsies in Prostate Cancer
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
NCT05245435CI-TRIAL-00064813withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment was not possible with the chosen inclusion/exclusion criteria at our Institution.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDHT-PET Scan | Diagnostic Test | — | UNRESOLVED |
| liquid biopsies | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- planned to undergo cytoreductive prostatectomy
- description
- planned to undergo cytoreductive prostatectomy
- interventionNames
- Diagnostic Test: liquid biopsies
- type
- OTHER
- label
- newly diagnosed metastatic hormone-sensitive prostate cancer patients
- description
- planned to undergo androgen deprivation therapy, and/or treatment with abiraterone acetate, and/or enzalutamide and/or docetaxel
- interventionNames
- Diagnostic Test: FDHT-PET Scan
- Diagnostic Test: liquid biopsies
- type
- OTHER
- label
- metastatic castration-resistant prostate cancer patients
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.