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Can a tiny beacon make prostate radiation safer?

NCT ID NCT03254420

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a device called Calypso, which tracks the prostate's position in real time during radiation, can reduce long-term side effects compared to standard image-guided radiation. 74 men with low- or intermediate-risk prostate cancer took part. The goal is to see if more precise targeting leads to fewer bowel and bladder problems after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Calypso beacon implant and moderate hypofractionation radiotherapy
What this could lead to
If successful, this could show that using the Calypso tracking system reduces long-term side effects from radiation for prostate cancer.
What could go wrong
This is a small, early-phase study (74 patients) and may not prove a clear benefit. The technology adds an extra implant procedure, which carries its own risks.

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

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

74 people

The number who actually took part.

Started

Aug 2016

Expected to finish

Dec 2028

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 to 80 years

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: * Localized prostate cancer, histologically proven. * No evidence of metastases (M0). No evidence of lymph nodes involvement (N0) (bilateral lymph node dissection is not mandatory if lymph node involvement risk is low according to the Partin tables). * Low-risk or intermediate clinical stage according to the D'Amico classification (T1-T2 and Gleason \< 8 and PSA \< 20 ng/ml) (appendix 3). * No grade \> 2 urinary or rectal clinical sign or symptom according to the CTCAE V4.03 scale. * Performance status ECOG ≤ 1. * No hip prosthesis or metallic vascular graft near the prostate. * No endopenian stent. * No pace maker, implanted defibrillator or neurostimulator. * No allergy to local anesthetics. * No irreversible anticoagulation or antiplatelet treatment for the implantation period. * Pelvic and abdominal anatomy compatible with the use of the Calypso® system (predictive detector to fiducials distance less than 19 cm, evaluated on planning CT-scan) (distance from skin surface to prostate center less than 17 cm). * Patient aged ≥ 18 and less than 80 years old. * Dated and signed written informed consent available. * Patients must be affiliated to a French Social Security System. Exclusion Criteria: * Indication of pelvic nodes irradiation. * Prior pelvic irradiation. * Biopsy-proven seminal vesicle invasion. * Prior bilateral orchiectomy. * Prior radical prostatectomy. * Other malignancy except adequately-treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease-free for at least 5 years. * Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. * Other uncontrolled systemic disease (cardiovascular, renal, liver, pulmonary embolism, etc.). * Known VIH positive patients (no specific test needed). * Known homozygote ATM Mutation (Ataxia telengiectasia).

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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

  • Institut regional du Cancer - Val d Aurelle

    Montpellier, 34298, France

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