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

This is an interventional treatment trial for Prostate Cancer Read More

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).