NCT03254420Active, not recruiting
Evaluation of Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins.
Randomized Phase II Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (RCMIGI)
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 74 (actual)
- First submitted
- 16 Aug 2017
- Start date
- 30 Aug 2016
- Primary completion date
- 15 Sept 2022
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Diseases
- Prostate cancer
- NCT number
- NCT03254420
What you commit to
- Study type: Interventional
- Participants enrolled: 74
- From 30 Aug 2016 to the primary completion date, 15 Sept 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Indication of pelvic nodes irradiation.
- Prior pelvic irradiation.
- Prior bilateral orchiectomy.
- Prior radical prostatectomy.
Other illness
- 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.).
Other
- Biopsy-proven seminal vesicle invasion.
- Known VIH positive patients (no specific test needed).
- Known homozygote ATM Mutation (Ataxia telengiectasia).
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut regional du Cancer - Val d Aurelle Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.