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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT02382094
Eligibility Criteria:
1. Histopathologically verified prostatic adenocarcinoma.
2. All consecutive patients referred for radiation therapy with combination method i.e. both external beam RT and HDR brachytherapy or other fractionation with curative intention.
3. Patients with intermediate risk group of prostate cancer will mainly be included in this study where radiotherapy with intention to cure is indicated and possible to perform. The intermediate risk group is defined as having 1-2 high risk factors for metastasis. Patients with low risk can only be possible to include if there is an indication of neo-adjuvant hormonal therapy.
4. No signs of distant metastasis.
5. Informed consent.
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Exclusion Criteria:
1. Failure to fulfill inclusion criteria.
2. Severe hepatic or renal failure, according to clinical and laboratory examinations, serum creatinine \> 225 mmol/l.
3. Concomitant diseases that would influence the planned treatment (e.g. Inflammatory bowel disease, urinary incontinence, severe atherosclerosis, myocardial infarction within last 6 months.
4. Previous diagnosis of other malignant diseases excluding patients who are free from relapse after at least 5 years of diagnosis. Patients with basal cell carcinoma are includable.
5. Inability of the patient to cope with the study rules, due to abuses, mentalstatus or other reasons
6. Participation in other clinical studies at the same time if it considers may hamper the assessment of QoL.
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Healthy Volunteers:
False
Sex:
MALE
Study:
NCT02382094
Study Brief:
Protocol Section:
NCT02382094