Description:
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.
Title
- Brief Title: Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins.
- Official Title: Randomized Phase II Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (RCMIGI)
Clinical Trial IDs
- ORG STUDY ID:
ICM-URC2015/33
- NCT ID:
NCT03254420
Conditions
Purpose
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.
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Image-guided radiation therapy (IGRT) with standard margins | Active Comparator | moderate hypofractionation during 4 weeks | |
| Calypso tracking system with margin reduction | Experimental | moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before | |
Eligibility Criteria
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).
| Maximum Eligible Age: | 80 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | assessment of grade > 2 late pelvic toxicities |
| Time Frame: | up to 2 years post treatment |
| Safety Issue: | |
| Description: | assessment of grade > 2 late pelvic toxicities between 3 months and 2 years after radiation period |
Details
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Institut du Cancer de Montpellier - Val d'Aurelle |
Last Updated
August 13, 2021
