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 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT00138918
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed adenocarcinoma of the prostate, previously untreated
2. Males ≥ 18 years of age.
3. Potential candidate for radical prostatectomy
4. Any of the following (minimum of 2 positive biopsies):
* Clinical stage T3
* Serum PSA \> 10 ng/ml
* Gleason score 7-10
* Gleason score 6 and \> 3 positive biopsies
5. ECOG performance status 0-1
6. WBC ≥ 3.0 x 10\^9/L
7. Hemoglobin ≥ 100 g/L
8. Platelets ≥ 100 x 10\^9/L
9. PTT, INR, AST, ALT, creatinine, total bilirubin within normal limits
10. Patients must sign an informed consent that complies with US Regulations (US 21 Code of Federal Regulations \[CFR\]) and the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP) prior to undergoing treatment.
Exclusion Criteria:
1. Prior hormone, radiation, or chemotherapy for prostate cancer
2. Evidence of active infection
3. Patients receiving therapeutic doses of warfarin or heparin
4. Severe end organ disease
5. Patients who otherwise would not be candidates for radical prostatectomy because of health or tumour factors
6. Patients will be excluded if they had any prior malignancy unless the prior malignancy was diagnosed and definitively treated at least five years previously and there has never been any evidence of recurrence.
7. Other serious illness, psychiatric, or medical condition that would not permit the patient to be managed according to the protocol.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00138918
Study Brief:
Protocol Section:
NCT00138918