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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT01444820
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months prior to randomization
2. Patient has been classified as high risk defined clinically as: T3 or T4, Gleason Score \> 8, and/ or PSA \> 20 (ng/mL or μg/L).
3. Pelvic and para-aortic lymph nodes must be negative on computerized tomography (CT scan) or magnetic resonance imaging (MRI) of the abdomen and pelvis performed within 12 weeks prior to randomization.
4. Investigations, including chest X-ray or chest CT scan and bone scan (with radiographs of suspicious areas) have been performed within 12 weeks prior to randomization and are negative for metastases.
5. Patients will have had a PSA test done at the time of diagnosis. This PSA test could be repeated within 28 days prior to randomization.
6. The patient may have received prior androgen suppression therapy provided that androgen suppression therapy commenced no more than 28 days prior to randomization.
7. The patient must not have received any cytotoxic anticancer therapy for prostate cancer prior to randomization.
8. ECOG performance status must be 0 or 1
9. Hematology and biochemistry: should be done within 28 days prior to randomization:
1. Hemoglobin \> 100 g/L
2. Absolute Neutrophils \> 1.5 x 109/L
3. Platelets \> 100 x 109/L
4. AST and/or ALT \< 1.5 x Upper Limit of Normal (ULN)
5. Alkaline phosphatase \< 2.5 x Upper Limit of Normal (ULN)
6. Total bilirubin \< ULN
7. Serum creatinine \< 1.5 x ULN
10. adequate birth control measures should be used by the participant
11. Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements.
12. Patients must be accessible for treatment and follow-up.
Exclusion Criteria:
1. Patients with a history of other malignancies, except: non-melanoma skin cancer; or other solid tumours curatively treated with no evidence of disease for \> 5 years.
2. The presence of small-cell or transitional-cell carcinoma in the biopsy specimen.
3. Patients who had previous chemotherapy for carcinoma of the prostate.
4. Patients who had prior surgical treatment for carcinoma of the prostate apart from trans-urethral resection, including bilateral orchiectomy.
5. Patients with any contraindication to pelvic radiotherapy: including, but not limited to, previous pelvic radiotherapy, inflammatory bowel disease or severe bladder irritability.
6. Patients with serious non malignant disease resulting in a life expectancy less than 3 years.
7. Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol
8. Known hypersensitivity to any protocol-indicated study medications.
9. Presence of bilateral hip replacement prostheses.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01444820
Study Brief:
Protocol Section:
NCT01444820