Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer
Completed · Phase 2
Conditions studied: Prostate Cancer
In brief
The goal of this clinical research study is to find out if a therapy using docetaxel chemotherapy with hormonal therapy taken before your scheduled surgery is beneficial to treatment of prostate cancer. The safety of this combination will also be studied.
Key facts
- Study ID
- NCT01076335
- Run by
- M.D. Anderson Cancer Center
- People needed
- 40
- Starts
- 2005-05-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2016-09-19
Who can join
Age: any. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- 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.
- Zubrod performance status 2 or better.
- 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.
- (# 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.
- Prior hormonal therapy up to 6 months is permitted. No concurrent ketoconazole is permitted.
- 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).
- 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.
- All patients must be evaluated in the Department of Urology and Department of Genitourinary Medical Oncology prior to signing informed consent.
You may not qualify if…
- Patients with small cell or sarcomatoid histology.
- Patients with clinical or radiological evidence of bone or other extranodal metastasis (M1b or M1c).
- Prior chemotherapy.
- Patients with severe or uncontrolled intercurrent infection.
- 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.
- Contraindications to corticosteroids.
- Uncontrolled severe hypertension, persistently uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease or HIV infection.
- Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years.
- Overt psychosis, mental disability or otherwise incompetent to give informed consent.
Where it is running
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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