Prostate CancerNCT05245435
Diagnostic and Prognostic Accuracy of FDHT-PET and Liquid Biopsies in Prostate Cancer
A study testing FDHT-PET Scan and liquid biopsies in people with Prostate Cancer, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- FDHT-PET Scan and liquid biopsies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2022to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- FDHT-PET Scan, liquid biopsies
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDHT-PET ScanDiagnostic test
[18F]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET)
liquid biopsiesDiagnostic test
circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients
| Study group | Role | What they receive |
|---|---|---|
| planned to undergo cytoreductive prostatectomy | Other | planned to undergo cytoreductive prostatectomy Receives: 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: liquid biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDHT total receptor expression (TRE) volume parameters compared to clinical follow-up
Measured: through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to course of disease
Measured: through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to androgen resistance
Measured: through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to liquid biopsy parameters
Measured: through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to IHC patterns
Measured: through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to stage of disease
Measured: through study completion, an average of 2 years
CTC count before and after treatment
Measured: through study completion, an average of 2 years
ctDNA abundance before and after treatment
Measured: through study completion, an average of 2 years
(Quantitative) IHC analysis of androgen specific receptor expression levels (FDHT) in tissue
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study startApr 2022 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Why it stopped: Recruitment was not possible with the chosen inclusion/exclusion criteria at our Institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Zeitlinger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245435
- Sponsor's protocol ID
- FDHTProstate_Protocol_V3
- Status last verified
- Mar 2023
- First submitted
- 28 Sep 2021
- Last updated
- 20 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05245435
- Acronym / sponsor ID
- FDHTProstate_Protocol_V3
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment was not possible with the chosen inclusion/exclusion criteria at our Institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| planned to undergo cytoreductive prostatectomy | Other | Diagnostic Test: liquid biopsiesplanned to undergo cytoreductive prostatectomy |
| newly diagnosed metastatic hormone-sensitive prostate cancer patients | Other | Diagnostic Test: FDHT-PET Scan, Diagnostic Test: liquid biopsiesplanned to undergo androgen deprivation therapy, and/or treatment with abiraterone acetate, and/or enzalutamide and/or docetaxel |
| metastatic castration-resistant prostate cancer patients | Other | Diagnostic Test: FDHT-PET Scan, Diagnostic Test: liquid biopsieswho were not pre-treated with enzalutamide or abiraterone acetate and planned treatment with those drugs |
| primary oligometastatic hormone-sensitive prostate cancer patients | Other | Diagnostic Test: liquid biopsieswho refuse to undergo cytoreductive radical prostatectomy will serve as control group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDHT-PET Scan[18F]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET) | Diagnostic test | metastatic castration-resistant prostate cancer patients, newly diagnosed metastatic hormone-sensitive prostate cancer patients |
| liquid biopsiescirculating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients | Diagnostic test | 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 |
Primary outcome
FDHT total receptor expression (TRE) volume parameters compared to clinical follow-up
Time frame: through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to course of disease
Time frame: through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to androgen resistance
Time frame: through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to liquid biopsy parameters
Time frame: through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to IHC patterns
Time frame: through study completion, an average of 2 years
FDHT total receptor expression (TRE) volume parameters compared to stage of disease
Time frame: through study completion, an average of 2 years
CTC count before and after treatment
Time frame: through study completion, an average of 2 years
ctDNA abundance before and after treatment
Time frame: through study completion, an average of 2 years
(Quantitative) IHC analysis of androgen specific receptor expression levels (FDHT) in tissue
Time frame: through study completion, an average of 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDHT-PET Scan and liquid biopsies in people with Prostate Cancer, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FDHT total receptor expression (TRE) volume parameters compared to clinical follow-up (time frame: through study completion, an average of 2 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.