WithdrawnNot Applicable

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

Stopped: Recruitment was not possible with the chosen inclusion/exclusion criteria at our Institution.

Austria0Started 2022-04

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 oligomet…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

FDHT total receptor expression (TRE) volume parameters compared to clinical follow-up

Timeframe: through study completion, an average of 2 years

FDHT total receptor expression (TRE) volume parameters compared to course of disease

Timeframe: through study completion, an average of 2 years

FDHT total receptor expression (TRE) volume parameters compared to androgen resistance

Timeframe: through study completion, an average of 2 years

FDHT total receptor expression (TRE) volume parameters compared to liquid biopsy parameters

Timeframe: through study completion, an average of 2 years

FDHT total receptor expression (TRE) volume parameters compared to IHC patterns

Timeframe: through study completion, an average of 2 years

FDHT total receptor expression (TRE) volume parameters compared to stage of disease

Timeframe: through study completion, an average of 2 years

Trial details

NCT IDNCT05245435

SponsorMedical University of Vienna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09

View on ClinicalTrials.gov More Prostate Cancer trials

Who can participate

Age range

18 Years – 75 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

FDHT total receptor expression (TRE) volume parameters compared to clinical follow-up

Timeframe: through study completion, an average of 2 years

FDHT total receptor expression (TRE) volume parameters compared to course of disease

Timeframe: through study completion, an average of 2 years

FDHT total receptor expression (TRE) volume parameters compared to androgen resistance

Timeframe: through study completion, an average of 2 years

FDHT total receptor expression (TRE) volume parameters compared to liquid biopsy parameters

Timeframe: through study completion, an average of 2 years

FDHT total receptor expression (TRE) volume parameters compared to IHC patterns

Timeframe: through study completion, an average of 2 years

FDHT total receptor expression (TRE) volume parameters compared to stage of disease

Timeframe: through study completion, an average of 2 years