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 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT01941550
Eligibility Criteria:
Inclusion Criteria:
* Surgically resectable high risk prostate cancer with a 5-year relapse probability ≥ 60% according to the Kattan pre-operative nomogram (cancer 2009, 115: 1005-1010)
* no prior therapy for prostate cancer such as androgen deprivation therapy, radiation therapy, or chemotherapy
* ECOG performance status 0-1
* No evidence of active infection
* Hemoglobin \>9.0 g/dL
* Absolute neutrophil count \>1.5 x 109/L,
* Platelet count \>100 x 109/L,
* AST/SGOT and/or ALT/SGPT \<2.5 x ULN;
* Total bilirubin \<1.0 x ULN,
* Serum creatinine \<1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \<60 mL/min should be excluded)
* Patient information and signature of informed consent
* Male ≥ 18 years
* Patients of reproductive age must take appropriate contraceptive precautions during and for 6 months after the end of their participation in the study
Exclusion Criteria:
* Evidence of lymph node, visceral or bone metastases
* previous major intrapelvic surgery
* previous radiation therapy to the small pelvis
* any type of malignancies within the last 5 years except basalioma and non-muscle invasive urothelial cancer of the urinary bladder
* previous chemotherapy with taxanes (docetaxel, paclitaxel, cabazitaxel) for any indication
* Hypersensitivity to the active substance or to any of the excipients
* Known or suspected brain metastases or leptomeningeal metastases
* Active or symptomatic viral hepatitis or chronic liver disease
* Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01941550
Study Brief:
Protocol Section:
NCT01941550