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:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-24 @ 3:34 PM
NCT ID:
NCT02370992
Eligibility Criteria:
Inclusion Criteria:
* WHO performance status 0-1
* No contra-indication for anaesthesia
* No history of irradiation of the pelvis
* No other oncologic malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient is disease free for at least 5 years.
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
Prostate (cancer) related:
* Histologically proven prostate cancer (adenocarcinoma) of low or intermediate risk following the D'Amico classification.
* Prostate volume \< 50 cc as measured on transrectal ultrasound
* Neo-adjuvant antiandrogen hormonal treatment is permitted to downsize the prostate volume or to cover waiting time till brachytherapy procedure. No adjuvant hormonal treatment is permitted.
* History of TransUrethral Resection of the prostate (TURp), performed at least 3 months before the brachytherapy procedure.
* Rim of prostate tissue of at least 1 cm around the post-TURp urethral defect at thepostero-lateral sides of the prostate
* Absence of significant TURp-induced urinary incontinence
* IPSS \<15
Exclusion Criteria:
* Locally advanced (stage T3 or T4 , or metastatic (stage N+ or M+) prostate cancer High grade tumours defined by Gleason score 8 or above Co-morbidity which would exclude the patient from a transperineal implant procedure.
Unable to give informed consent.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
90 Years
Study:
NCT02370992
Study Brief:
Protocol Section:
NCT02370992