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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT01048151
Eligibility Criteria:
Inclusion Criteria
* Histological documented high-risk localized prostate cancer defined by clinical stage \>=T3 or Gleason score ≥8.
* Lack of distant metastases (including bone, liver, or extrapelvic lymph node metastases) on standard CT and bone scanning. Patients with suspected or histologically confirmed pelvic lymph node metastases are eligible.
* Normal organ function defined by:
* Hgb \> 10 mg/dl (may be transfused or on erythropoietin);
* Platelets \> 100,000/l;
* Absolute neutrophil count \> 1500/l.
* Bilirubin \< 1.5 mg/dl.
* AST and ALT \< 1.5X upper limit of normal.
* Written signed informed consent.
Exclusion Criteria
* Absolute or relative contraindication to prostate radiotherapy including but not limited to prior pelvic radiotherapy, active infectious or inflammatory colitis, and inability to lay supine for daily radiation treatments.
* Requirement for ongoing antithrombotic treatment with coumadin or one of its derivatives, heparin or one of its derivatives, or thrombin inhibitors. Low dose aspirin for prevention of cardiovascular events is acceptable.
* Active vascular disease defined as a stroke, transient ischemic attack (TIA), myocardial infarction, or any vascular procedure performed for ischemic disease within the last 6 months.
* History of thrombosis (pulmonary embolism (PE) or deep vein thrombosis (DVT)) or known thrombophilia.
* Coagulopathy (INR\>1.5, PTT ratio \>1.5)
* Major surgery within the last 1 month (excludes minor superficial surgeries, biopsies, or minimally invasive approaches).
* Chemotherapy or experimental medications within 4 weeks of study entry.
* Chronic treatment for greater than 6 months with oral steroids at doses above 10 mg/day prednisolone (or equivalent).
* Clinical evidence of active infection of any type.
* HIV-positive patients receiving combination anti-retroviral therapy.
* Other significant concurrent medical or psychiatric illness that would limit compliance with study.
* Unwilling to use condoms or another barrier method of birth control for at least 8 weeks following the last dose of TNFerade™ Biologic and some form of birth control for at least one year. -
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT01048151
Study Brief:
Protocol Section:
NCT01048151