Hormone Therapy With or Without Squalamine Lactate in Treating Patients Who Are Undergoing a Radical Prostatectomy for Locally Advanced Prostate Cancer

• Status: Withdrawn
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: Male

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 growth of prostate cancer by blocking blood flow to the tumor. Giving hormone therapy together with squalamine lactate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This randomized phase II trial is studying how well giving hormone therapy together with squalamine lactate works compared to hormone therapy alone in treating patients who are undergoing a radical prostatectomy for locally advanced prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Androgen Antagonists; Bicalutamide; Hormones; Leuprolide; Squalamine

Criteria

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