Evaluation of Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins.
NCT ID: NCT03254420
Last Updated: 2025-10-01
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
74 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-08-30
Study Completion Date
2028-12-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Prostate Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Image-guided radiation therapy (IGRT) with standard margins
moderate hypofractionation during 4 weeks
Group Type
ACTIVE_COMPARATOR
moderate hypofractionation Radiotherapy
Intervention Type
RADIATION
moderate hypofractionation Radiotherapy
Calypso tracking system with margin reduction
moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before
Group Type
EXPERIMENTAL
Calypso beacon implant
Intervention Type
DEVICE
Calypso beacon implant before radiotherapy
moderate hypofractionation Radiotherapy
Intervention Type
RADIATION
moderate hypofractionation Radiotherapy
Interventions
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Calypso beacon implant
Calypso beacon implant before radiotherapy
Intervention Type
DEVICE
moderate hypofractionation Radiotherapy
moderate hypofractionation Radiotherapy
Intervention Type
RADIATION
Eligibility Criteria
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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.
* 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).
* 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).
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Riou Olivier
Role: STUDY_CHAIR
Institut régional du Cancer de Montpellier
Locations
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Institut regional du Cancer - Val d Aurelle
Montpellier, , France
Site Status
Countries
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France
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ICM-URC2015/33
Identifier Type: -
Identifier Source: org_study_id
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NCT03366792
TERMINATED
NA
Hypofractionated Image Guided Proton Therapy for Low andIntermediate Risk Prostate Cancer
NCT02040610
RECRUITING
NA
Evaluation of Radiation Therapy Positioning System (RTPS) in Patients With Localized Prostate Cancer
NCT00921193
COMPLETED
NA
Prostate Localization During Radiotherapy Using a Ni-Ti Stent and Electronic Portal Imaging - Protocol II
NCT00250224
COMPLETED
PHASE1
Phase I Study of Intensity Modulated Radiation Therapy for Prostate Cancer
NCT00124917
TERMINATED
PHASE1
Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy
NCT06599476
ACTIVE_NOT_RECRUITING
NA
Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer
NCT03023345
COMPLETED
NA
BIOPROP20: Biologically Optimised IMRT for Prostate Radiotherapy Hypofractionated Radiotherapy With Intra-prostatic Boosts to Tumour Nodules in Men With Intermediate and High Risk Prostate Cancer
NCT02125175
COMPLETED
NA
Clinical and Dosimetric Study of Patients Treated With 177Lu-PSMA-617 for Prostate Cancer.
NCT06700057
RECRUITING
Safety Study of Pelvic and Prostatic SIB-IMRT With Long-term Androgen Deprivation for High Risk Localized Prostate Cancer
NCT01704027
TERMINATED
PHASE2
Intensity-Modulated External Beam Radiation Therapy in Treating Patients With Prostate Cancer
NCT01117935
COMPLETED
NA