Can a One-Two radiation punch improve prostate cancer control?
NCT ID NCT05003752
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing a combination of two radiation techniques for men with intermediate or high risk prostate cancer. Participants receive a shortened course of external beam radiation followed by a single high-dose brachytherapy boost, with optional hormone therapy. The trial measures urinary, bowel, and sexual side effects, and tracks cancer control and survival over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Combined hypofractionated external beam radiation therapy plus high-dose-rate brachytherapy boost, with optional androgen deprivation therapy (goserelin)
- What this could lead to
- If it works, this could offer a shorter, more intense radiation schedule that controls prostate cancer while limiting side effects.
- What could go wrong
- This is a small Phase 1/2 trial, so safety and effectiveness are still uncertain. The combined radiation may cause urinary, bowel, or sexual side effects, and larger studies would be needed to confirm any benefit.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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40 people
The number who actually took part.
- Started
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Aug 2021
- Expected to finish
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Aug 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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Male participants only
- 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.
Inclusion Criteria: * The patient must consent to be in the study and must have signed an approved consent form * Age \> 18 years old. * Life expectancy of at least five years, excluding his diagnosis of prostate cancer. * Histopathologically proven primary adenocarcinoma of the prostate * The patient must be registered within 180 days following the histopathological confirmation of the malignancy * Prostate volume \< 80ml * International Prostate Symptom Score (IPSS) \< 18 * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Patients with a history of non-prostate malignancies are eligible if they have been disease-free for 5 or more years prior to enrolment, are deemed by their physician to be at low risk for recurrence and they did not need pelvic radiotherapy as part of their treatment. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin. Exclusion Criteria: * Histopathological confirmation or suspicion in conventional or molecular imaging of regional or distant metastases * Prior pelvic radiotherapy * Known autoimmune disorders (e.g. inflammatory bowel disease, lupus, scleroderma) * Prior TURP * MRI non compatible metal implants * Pre-existing fistulae * Contraindication for general and spinal anaesthesia * Inability to be placed in lithotomy position * Any treatment with radiation therapy, chemotherapy, immunotherapy, biotherapy and/or hormonal therapy for the currently diagnosed prostate cancer prior to registration. * History of non-prostate malignancy, apart from patients that have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. * Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
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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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German Oncology Center
Limassol, 4108, Cyprus
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Other studies related to the condition(s) this trial covers.
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