Evaluation of Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (RCMIGI)

February 3, 2026 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Randomized Phase II Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (RCMIGI)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34298
        • Institut regional du Cancer - Val d Aurelle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Image-guided radiation therapy (IGRT) with standard margins
moderate hypofractionation during 4 weeks
Radiation: moderate hypofractionation Radiotherapy
moderate hypofractionation Radiotherapy
Experimental: Calypso tracking system with margin reduction
moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before
Radiation: moderate hypofractionation Radiotherapy
moderate hypofractionation Radiotherapy
Device: Calypso beacon implant
Calypso beacon implant before radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Grade > 2 Late Pelvic Toxicities
Time Frame: between 3 months and 2 years after radiation period
assessment of grade > 2 late pelvic toxicities between 3 months and 2 years after radiation period
between 3 months and 2 years after radiation period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological Relapse-free Survival
Time Frame: at 5 years after the radiotherapy
evaluate at 5 years with PSA dosage
at 5 years after the radiotherapy
Uncomplicated Survival (Local Recurrence or Metastatic Recurrence)
Time Frame: at 5 years after the radiotherapy
evaluate et 5 years after the treatment with radiological exam
at 5 years after the radiotherapy
Overall Survival
Time Frame: from the baseline to 5 years after the radiotherapy
number of death from baseline to 5 years after the treatment
from the baseline to 5 years after the radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Riou Olivier, Institut Regional Du Cancer de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2016

Primary Completion (Actual)

September 15, 2022

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 16, 2017

First Submitted That Met QC Criteria

August 16, 2017

First Posted (Actual)

August 18, 2017

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM-URC2015/33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on moderate hypofractionation Radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe