Status:
WITHDRAWN
Hormone Therapy With or Without Squalamine Lactate in Treating Patients Who Are Undergoing a Radical Prostatectomy for Locally Advanced Prostate Cancer
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide and bicalutamide, may stop the adrenal glands from making androgens. Squalamine lactate may stop the growt...
Detailed Description
OBJECTIVES: * Compare the effect of neoadjuvant androgen-ablation therapy with vs without squalamine lactate on induced tumor regression and grade migration in patients with locally advanced high-ris...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Locally advanced disease
- No metastatic disease
- High-risk characteristics, meeting ≥ 1 of the following criteria:
- Large, hard tumor on digital exam
- Aggressive-appearing cancer cells on biopsy
- Prostate-specific antigen \> 10 ng/mL
- PATIENT CHARACTERISTICS:
- Performance status
- 0-1
- Life expectancy
- Not specified
- Hematopoietic
- WBC \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hemoglobin \> 11.0 g/dL
- Hepatic
- Bilirubin \< 2 times upper limit of normal (ULN)
- SGOT and SGPT \< 2 times ULN
- PT and PTT normal
- Renal
- Creatinine \< 1.8 g/dL
- Cardiovascular
- No history of ventricular arrhythmia or dysfunction
- No congestive heart failure
- No symptomatic coronary artery disease
- No prior myocardial infarction
- No history of thromboembolic disease (e.g., deep vein thrombosis or stroke) within the past 12 months
- No other significant cardiovascular disease
- Pulmonary
- No pulmonary embolism within the past 12 months
- No exercise-limiting respiratory disease
- Other
- Fertile patients must use effective barrier method contraception
- No sexual intercourse for 6 weeks after surgery
- No uncontrolled diabetes
- No serious acute infection
- No other malignancy except nonmelanoma skin cancer
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior squalamine lactate
- Chemotherapy
- No prior chemotherapy for prostate cancer
- No concurrent anticancer chemotherapy
- Endocrine therapy
- No concurrent systemic corticosteroids
- Radiotherapy
- No prior radiotherapy for prostate cancer
- No concurrent radiotherapy
- Surgery
- No prior surgery for prostate cancer
- No other concurrent surgery
- Other
- At least 6 weeks since prior and no concurrent use of over-the-counter or herbal drugs that have estrogenic activity
- No participation in another investigational study within the past 3 months
- No concurrent participation in another investigational study
Exclusion
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00244920
Start Date
January 1 2002
End Date
June 1 2007
Last Update
May 28 2012
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