Evaluation of Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strat… (NCT03254420) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins.
France74 participantsStarted 2016-08-30
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of Grade > 2 Late Pelvic Toxicities
Timeframe: between 3 months and 2 years after radiation period
Trial details
NCT IDNCT03254420
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle