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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT01076335
Eligibility Criteria:
Inclusion Criteria:
1. Patients with adenocarcinoma of the prostate that in the opinion of the surgeon could be resectable after response to systemic therapy. Ductal carcinoma variant is included.
2. All patients must be regarded as acceptable anesthetic risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the neoadjuvant therapy.
3. Zubrod performance status 2 or better.
4. All patients must have thorough tumor staging and meet one of the following criteria: a) Either lymph node biopsy or lymph node dissection demonstrating presence of lymph node metastasis. b) Pelvic or retroperitoneal lymphadenopathy \>/= 2.0 cm visualized on CT scan (biopsy is not required if \>/= 2.0 cm and in typical distribution) c) Primary tumor Gleason score \>/= 8 and serum PSA concentration \>/= 25 ng/ml, indicating high risk of occult lymph node metastases.
5. (# 4 cont'd) d) Primary tumor stage T3 and Gleason score \>/= 7, indicating high risk of occult lymph node metastases. e) Primary tumor stage T4 indicating high risk of occult lymph node metastases.
6. Prior hormonal therapy up to 6 months is permitted. No concurrent ketoconazole is permitted.
7. Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of \> 1,500/mm\^3 and platelet count of \> 100,000/mm\^3; adequate hepatic function defined with a total bilirubin of \< 1.5 mg/dl and AST/ALT \< 2X the upper limits of normal; adequate renal function defined as serum creatinine clearance \> 40 cc/min (measured or calculated).
8. Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.
9. All patients must be evaluated in the Department of Urology and Department of Genitourinary Medical Oncology prior to signing informed consent.
Exclusion Criteria:
1. Patients with small cell or sarcomatoid histology.
2. Patients with clinical or radiological evidence of bone or other extranodal metastasis (M1b or M1c).
3. Prior chemotherapy.
4. Patients with severe or uncontrolled intercurrent infection.
5. Patients with New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina or history of myocardial infarction within the last 6 months.
6. Contraindications to corticosteroids.
7. Uncontrolled severe hypertension, persistently uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease or HIV infection.
8. Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years.
9. Overt psychosis, mental disability or otherwise incompetent to give informed consent.
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT01076335
Study Brief:
Protocol Section:
NCT01076335