Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT03254420
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).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03254420
Study Brief:
Protocol Section:
NCT03254420