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

Launched by INSTITUT DU CANCER DE MONTPELLIER - VAL D'AURELLE · Aug 16, 2017

Keywords

ClinConnect Summary

This clinical trial is investigating a new technology called the Calypso® System, which uses tiny devices implanted in the prostate to track its position during radiation therapy for prostate cancer. The goal is to see if using this system with smaller treatment margins can reduce the rate of late side effects in the pelvic area after radiation treatment compared to traditional methods.

To participate, men aged 18 to 80 with localized prostate cancer that has not spread may be eligible. They should have low to intermediate risk according to specific medical guidelines and must not have certain health conditions that could interfere with the treatment or study. Participants can expect to receive either the new tracking system or standard care and will be monitored for any side effects related to the treatment. This trial is currently active but not recruiting new participants.

Gender

MALE

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).