Can a One-Two radiation punch improve prostate cancer control?

NCT ID NCT05003752

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

40 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Male participants only

Healthy volunteers

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

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

  • German Oncology Center

    Limassol, 4108, Cyprus

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