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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT00452556
Eligibility Criteria:
Inclusion Criteria:
* A histological diagnosis of adenocarcinoma of the prostate
* Life expectancy greater than 5 years.
* ECOG performance status \< 1.
* Signed, written informed consent prior to randomization.
* Any one, or more, of the following criteria:
* TNM stage T2c, T3a or T3b
* Gleason score 8 to 10, as determined by central institutional review.
* PSA \> 20 mcg/L, but \< 50 mcg/L. OR Have a \> 50% chance of recurrence after radical prostatectomy, as predicted by the Kattan Nomogram and
* Post - op PSA \< 1.0 mcg/L.
* Must be able to start protocol treatment within 6 months from date of surgery.
* No evidence of metastasis, as determined by bone scan and Chest x-ray/CT abdomen/pelvis.
* Adequate marrow reserve and end - organ function
* Leukocytes \> 3,000/mcL.
* Absolute neutrophil count \> 1,500/mcL
* Platelets \> 100,000/mcL
* Total bilirubin \< 1.2 x upper limit of normal for the institution.
* AST(SGOT)/ALT(SGPT) greater than 1.5 X institutional upper limit of normal
* Creatinine within normal institutional limits OR
* Creatinine clearance \> 60 mL/min using the Crockfort - Gault formula for patients with creatinine levels above institutional normal.
Exclusion Criteria:
* PSA \> 50 µg/L.
* Previous pelvic radiotherapy
* Sensitivity to Docetaxel chemotherapy.
* Grade 2 or greater NCI CTCAE version 3.0 neuropathy.
* Prior malignancy within the last 5 years, other than prostate cancer, except:
* Patients with adequately treated non - melanoma cutaneous malignancies.
* Patients with a history of a curatively treated malignancy (including patients with superficial bladder cancer) who have not had evidence of recurrence for a minimum of 5 years.
* Patients with a history of hypersensitivity to polysorbate 80.
* Patients with a known history of viral hepatitis (B,C).
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00452556
Study Brief:
Protocol Section:
NCT00452556