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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT01839994
Eligibility Criteria:
Inclusion Criteria:
1. Pathologically proven adenocarcinoma of the prostate
2. Clinical stage T1-T3a (Intermediate or high risk features according to NCCN criteria)
3. No evidence of nodal or distant spread as determined by chest X-ray, bone scan and abdominal ultrasound or CT-scan or other investigations such as Positron Emission Tomography \[PET\] scan if required
4. No evidence of bulky spread beyond the capsule of the prostate, no seminal vesicle involvement assessed by TRUS or MRI of pelvis.
5. Good performance status (ZUBROD \<2, Karnofsky index \>=80%).
6. No contradictions for spinal anesthesia.
7. No contradictions for hormonal treatment (androgen deprivation).
8. Adequate bone marrow, renal and liver function.
9. Life expectancy in excess of 5 years.
10. No prior malignancy, except basal or squamous cell skin cancer.
11. Informed consent for participation in the study (confirmed by the signature together with the standard medical consent form for radiotherapy within the pelvis)
Exclusion Criteria:
1. Different histology than adenocarcinoma.
2. Previous or concurrent malignancy, with the exception of basal cell carcinoma of the skin.
3. Locally advanced disease: bulky T3a and/or T3b.
4. Presence of metastatic disease (nodal and/or distant).
5. PSA \>100ng/ml
6. Any previous therapy other than hormonal treatment.
7. Concurrent uncontrolled medical conditions.
8. Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
9. Withdrawal of informed consent.
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Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01839994
Study Brief:
Protocol Section:
NCT01839994