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

Prostate Cancer Clinical Trial

— RCMIGI  

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03254420
• Other study ID #: ICM-URC2015/33
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 30, 2016
• Est. completion date: December 2028

Study information

• Verified date: June 2023
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Calypso beacon implant
Calypso beacon implant before radiotherapy

Radiation:
• moderate hypofractionation Radiotherapy
moderate hypofractionation Radiotherapy

Locations

Country	Name	City	State
France	Institut regional du Cancer - Val d Aurelle	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of grade > 2 late pelvic toxicities	assessment of grade > 2 late pelvic toxicities between 3 months and 2 years after radiation period	up to 2 years post treatment