Can a tiny beacon make prostate radiation safer?
NCT ID NCT03254420
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
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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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74 people
The number who actually took part.
- Started
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Aug 2016
- Expected to finish
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Dec 2028
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 to 80 years
- 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: * 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
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Institut regional du Cancer - Val d Aurelle
Montpellier, 34298, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
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- Light-Based imaging aims to spot prostate cancer left behind after surgery
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer