Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2008-09-22
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as flutamide and buserelin may stop the adrenal glands from producing androgens. OGX-011 may help flutamide and buserelin kill more tumor cells by making tumor cells more sensitive to the drugs. Giving flutamide and buserelin with OGX-011 before surgery may shrink the tumor so it can be removed during surgery.

PURPOSE: Phase I trial to study the effectiveness of combining hormone therapy with OGX-011 before radical prostatectomy in treating patients who have prostate cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: Buserelin; Flutamide; Hormones

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• High-risk, localized disease that is previously untreated

• Minimum of 2 positive biopsies

• Meets at least 1 of the following criteria:

• Stage T3

• Serum PSA greater than 10 ng/mL

• Gleason score 7-10

• Gleason score 6 and at least 3 positive biopsies

• Potential candidate for radical prostatectomy

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10.0 g/dL

Hepatic

• Bilirubin normal

• AST and ALT normal

• PTT normal

• INR normal

Renal

• Creatinine normal

Cardiovascular

• No significant cardiac dysfunction

Other

• Fertile patients must use effective contraception

• No known hypersensitivity to oligonucleotides, luteinizing hormone-releasing hormone analogs, or anti-androgens

• No evidence of active uncontrolled infection

• No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer

• No other serious illness, psychiatric disorder, or medical condition that would preclude study compliance

• No history of a significant neurological disorder that would preclude informed consent

• No geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for prostate cancer

Endocrine therapy

• No prior hormonal therapy for prostate cancer

Radiotherapy

• No prior radiotherapy for prostate cancer

• No concurrent radiotherapy

Surgery

• Not specified

Other

• No concurrent heparin or warfarin anticoagulation

• No other concurrent investigational therapy

• No other concurrent cytotoxic therapy