Patients With Metastasized Prostate Cancer Whose Prostate-specific Antigen-level (PSA) Remains >0… (NCT07644754) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Patients With Metastasized Prostate Cancer Whose Prostate-specific Antigen-level (PSA) Remains >0,2 ng/ml After Six Months of Dual Antihormonal Therapy Will Receive Radiotherapy to the Prostate and Radiotherapy to Refractory Metastases
27 participantsStarted 2026-07
Plain-language summary
The goal of this clinical trial is to learn if radiotherapy to the prostate and PET-positive (positron emission tomography) metastasis will lead to radiological response on PSMA-PET (prostate specific membrane antigen-PET). Patients who receive combined androgen deprivation therapy for de novo metastasized prostate cancer and show an incomplete PSA-response (\>0,2 ng/ml after six months) and exhibit at least four bone metastases on PET-imaging at this time point (without metastases to organs) can take part in this study.
The main questions it aims to answer are:
• Does radiotherapy to the prostate and PET-positive metastases lead to a radiological response one year after radiotherapy? Researchers will analyze PET-imaging prior to radiotherapy to the prostate and metastases and one yeare thereafter.
Participants will:
* Continue taking combined androgen-deprivation therapy
* Receive a total of three PSMA-PET/CT scans
* Receive radiotherapy to the prostate and PET-positive metastases
* Visit the clinic every three months for 36 months
* Complete quality of life questionnaires at every visit
Who can participate
Age range
18 Years – 85 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:
* Prostate adenocarcinoma
* de novo metastasized prostate cancer (at least 4 osseous metastases +/- lymphonodal metastases)
* first-line combined antihormonal therapy (ADT + ARPI) for six months
* PSA \> 0,2 ng/ml after six months of combined ADT/ARPI therapy
* multimetastasized disease stage without visceral metastases on imaging at first diagnosis (PET, CT, or bone scan)
* \<16 osseous/lymphnodal metastases on response assessment imaging (PSMA-PET/CT) after six months of combined antihormonal therapy
Exclusion Criteria:
* neuroendocrine histology
* visceral metastases (M1c)
* prior radiotherapy to the pelvis
* PSA \< 0,2 ng/ml after 6 months of combined antihormonal therapy
* prior prostatectomy
* contraindication against PSMA-PET/CT and/or radiotherapy to the prostate/metastases
* HIFU or TUR-P within 6 months of study treatment
* other active malignancy two years prior to study inclusion (except skin cancer in remission)
* relevant GU/GI condition (active fistula or other)
* known tumor predisposition syndrome
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
1
Radiological Progression-Free Survival
Timeframe: 12 months after radiotherapy of metastases