An interventional study of Calypso beacon implant and moderate hypofractionation Radiotherapy in Prostate Cancer, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Active, not recruiting at 1 site in France. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Not applicable, Interventional, and Treatment
The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology using electromagnetic transponders implanted within the prostate. It is a real-time target tracking system that takes into account both inter- and intrafractional target motion. So the exact position and movement of the prostate can be determined during radiation therapy treatment.
The aim of this study is to assess pelvic late toxicity rate after intensity-modulated radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In this randomized study, patients will receive IGRT treatment using the Calypso system or a conventional IGRT treatment.
Prostate cancer is the most frequent cancer in men. Radiotherapy is one of the reference treatments for localized prostate cancer. Prostate was initially thought to be a non-moving target, but the newest reports have raised the contrary as evidence. Image-guided radiotherapy (IGRT) is a current standard treatment for localized prostate cancer which enables to take into account interfractional prostate motion before treatment.
The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology using electromagnetic transponders implanted within the prostate. It is a real-time target tracking system that takes into account both inter- and intrafractional target motion. So the exact position and movement of the prostate can be determined during radiation therapy treatment.
As Planned Target Volume (PTV) margins integrate set-up margins and the management of organ motion, margin reduction can reasonably be considered in case of target motion management improvement.
To date, no prospective randomized clinical data is available using this technique for the treatment of low- or intermediate-risk prostate cancer patients with modern standard fractionation radiotherapy and image guidance.
The aim of this study is to assess pelvic late toxicity rate after intensity-modulated radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In this randomized study, patients will receive IGRT treatment using the Calypso system or a conventional IGRT treatment.
Exclusion Criteria:
moderate hypofractionation during 4 weeks
Radiation: moderate hypofractionation Radiotherapy
moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before
Device: Calypso beacon implant · Radiation: moderate hypofractionation Radiotherapy
Calypso beacon implant before radiotherapy
moderate hypofractionation Radiotherapy
Assessment of Grade > 2 Late Pelvic Toxicities
assessment of grade \> 2 late pelvic toxicities between 3 months and 2 years after radiation period
Time frame: between 3 months and 2 years after radiation period
Biological Relapse-free Survival
evaluate at 5 years with PSA dosage
Time frame: at 5 years after the radiotherapy
Uncomplicated Survival (Local Recurrence or Metastatic Recurrence)
evaluate et 5 years after the treatment with radiological exam
Time frame: at 5 years after the radiotherapy
Overall Survival
number of death from baseline to 5 years after the treatment
Time frame: from the baseline to 5 years after the radiotherapy
| Milestone | Image-guided Radiation Therapy (IGRT) With Standard Margins | Calypso Tracking System With Margin Reduction |
|---|---|---|
| Started | 29 | 45 |
| Completed | 26 | 44 |
| Not completed | 3 | 1 |
assessment of grade \> 2 late pelvic toxicities between 3 months and 2 years after radiation period
| Participants | Image-guided Radiation Therapy (IGRT) With Standard Margins | Calypso Tracking System With Margin Reduction |
|---|---|---|
| failure | 5 | 5 |
| success | 21 | 39 |
evaluate at 5 years with PSA dosage
| participants | Image-guided Radiation Therapy (IGRT) With Standard Margins | Calypso Tracking System With Margin Reduction |
|---|---|---|
| Biological Relapse-free Survival | 26 | 37 |
evaluate et 5 years after the treatment with radiological exam
| participants | Image-guided Radiation Therapy (IGRT) With Standard Margins | Calypso Tracking System With Margin Reduction |
|---|---|---|
| Uncomplicated Survival (Local Recurrence or Metastatic Recurrence) | 26 | 41 |
number of death from baseline to 5 years after the treatment
| participants | Image-guided Radiation Therapy (IGRT) With Standard Margins | Calypso Tracking System With Margin Reduction |
|---|---|---|
| Overall Survival | 0 | 2 |
Collected over adverse event data were collected from the baseline to 5 years after the radiotherapy. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Image-guided Radiation Therapy (IGRT) With Standard Margins | 0/26 (0%) | 2/26 (7.7%) | 26/26 (100%) |
| Calypso Tracking System With Margin Reduction | 2/44 (4.5%) | 9/44 (20.5%) | 44/44 (100%) |
| Event | Image-guided Radiation Therapy (IGRT) With Standard Margins | Calypso Tracking System With Margin Reduction |
|---|---|---|
| prostatitis grade 3Reproductive system and breast disorders | 0/26 | 2/44 |
| hemovhromatosisMetabolism and nutrition disorders | 1/26 | 0/44 |
| lithiasis choledocholithiasis grade 3Hepatobiliary disorders | 1/26 | 0/44 |
| thrombocytopenia grade 4Blood and lymphatic system disorders | 0/26 | 1/44 |
| basela cell carcinoma grade 2Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/26 | 1/44 |
| vascular stent stenosis grade 3General disorders | 0/26 | 1/44 |
| peripheral artery stenosis grade 3Vascular disorders | 0/26 | 1/44 |
| malignant melanoma grade 2Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/26 | 1/44 |
| colon cancer metastatic grade 5Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/26 | 1/44 |
| cerebral hematoma grade 3Nervous system disorders | 0/26 | 1/44 |
| Event | Image-guided Radiation Therapy (IGRT) With Standard Margins | Calypso Tracking System With Margin Reduction |
|---|---|---|
| renal and urinary disordersRenal and urinary disorders | 26/26 | 42/44 |
| reproductive system and breast disordersReproductive system and breast disorders | 19/26 | 31/44 |
| gastrointestinal disordersGastrointestinal disorders | 16/26 | 28/44 |
| general disorders and reaction at the site of administrationGeneral disorders | 10/26 | 13/44 |
| vascular disordersVascular disorders | 8/26 | 10/44 |
| psychiatric disordersPsychiatric disorders | 6/26 | 13/44 |
| neoplasms malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/26 | 4/44 |
| skin and cubcutaneous tissue disordersSkin and subcutaneous tissue disorders | 2/26 | 1/44 |
| musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders | 1/26 | 2/44 |
| ocular infectionEye disorders | 1/26 | 0/44 |
| Age, Continuous(years) | Image-guided Radiation Therapy (IGRT) With Standard Margins | Calypso Tracking System With Margin Reduction | Total |
|---|---|---|---|
| Mean | 68 (52 to 78) | 70 (51 to 78) | 69.5 (51 to 78) |
| Sex: Female, Male(Participants) | Image-guided Radiation Therapy (IGRT) With Standard Margins | Calypso Tracking System With Margin Reduction | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 29 | 45 | 74 |
| Race and Ethnicity Not Collected(Participants) | Image-guided Radiation Therapy (IGRT) With Standard Margins | Calypso Tracking System With Margin Reduction | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
Supporting information: Study protocol, Sap, Icf, Csr
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Institut du Cancer de Montpellier - Val d'Aurelle