Can targeted radiation slow prostate cancer that resists hormone therapy?
NCT ID NCT04141709
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This trial tests whether high-dose radiation aimed at a few cancer spots can slow the disease in men with prostate cancer that has stopped responding to hormone therapy. Half the participants receive radiation to their metastases, while the other half are watched without immediate treatment. Researchers measure how long it takes for PSA levels to rise, which signals cancer progression. The radiation can be given in a few large doses or in many smaller doses, depending on the size and location of the metastases.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- local ablative radiotherapy (radiation therapy to metastases)
- What this could lead to
- If it works, this could offer a way to delay disease progression and postpone the need for stronger treatments in men with a few prostate cancer metastases that no longer respond to hormone therapy.
- What could go wrong
- This is a randomized trial, but it is relatively small and the treatment may cause side effects from radiation. The benefit over simply watching and waiting is not yet proven, and results may not apply to all patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2019
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Indication: Oligometastases (1-5) in castration-resistant prostate carcinoma Inclusion Criteria: * Patient with good general condition (WHO 0-1) * Histologically confirmed prostate carcinoma * After definitive local therapy, e.g. radical prostatectomy or definitive radiotherapy (also after neo-adjuvant hormone therapy, after postoperative radiotherapy). * PSA progression under ongoing androgen deprivation (defined as three consecutive increasing PSA values at intervals of \> 4 weeks and testosterone in the castration area \<50ng/dl or \<1.73nmol/) * Minimum duration of androgen deprivation 6 months before inclusion in study * Present complete staging (max. 6 weeks old), preferably by means of PET hybrid imaging with prostate-specific PET tracer * Imaging detection of individual active or progressive metastases (max. 5, depending on location) that are accessible to local ablative radiotherapy (histological confirmation of the metastases is not required) * No parallel participation to further clinical therapy trials up to 4 weeks before and after radiation therapy * Individual case discussion in an interdisciplinary tumor board * Patient's ability to consent and written consent Exclusion Criteria: * Severe concomitant disease that limits further life expectancy to \< 5 years according to the physician's assessment. * PSA \> 20ng/ml, testosterone \>50 dl or \>1,73nmol/l * visceral metastasis (e.g. lung, liver, brain) * lack of compliance * previous taxane-containing chemotherapy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden
Dresden, Saxony, 01307, Germany
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University Clinic Tübingen, Clinic for Radiation Oncology
Tübingen, Germany
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University Hospital Heidelberg, Department of Radiation Oncology
Heidelberg, Germany
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University Medical Center Freiburg, Department of Radiation Oncology
Freiburg im Breisgau, Germany
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