Prostate Cancer Clinical Trial

Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.

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Full Description

OBJECTIVES:

Determine the clinical benefit, as measured by time to progression and overall survival, of chemo/hormonal therapy compared to androgen ablation alone, when given as the initial systemic treatment in patients with acinar adenocarcinoma of the prostate that is not amenable to local therapy.
Validate the clinical significance of PSA criteria for progression.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients are treated with medical or surgical castration followed by an anti-androgen therapy with either flutamide, bicalutamide, or nilutamide.
Arm II: Patients receive chemo/hormonal therapy for 3 eight week courses, followed by total androgen blockade. Each course consists of 6 weeks of cytotoxic therapy with doxorubicin, ketoconazole, vinblastine, and estramustine followed by 2 weeks of rest. These patients are also maintained on hydrocortisone both during treatment and during rest.

Patients in arm II have a long-term central venous access device inserted.

PROJECTED ACCRUAL: A total of 368 patients will be accrued for this study.

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Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically proven acinar adenocarcinoma of the prostate
Metastatic or locally advanced disease that either is not appropriately treated with surgery or radiation, or has recurred following previous "definitive" local therapy
No CNS metastases
No histologic subtypes, such as pure ductal or any component of small cell carcinoma
Elevated PSA (at least 1.0 ng/mL in patients with prior prostatectomy or 4.0 ng/mL in those with prostate in place)

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

Zubrod 0-2

Life expectancy:

At least 3 years

Hematopoietic:

Absolute neutrophil count greater than 1,500/mm^3
Platelet count greater than 100,000/mm^3

Hepatic:

Conjugated bilirubin no greater than 0.8 mg/dL or total bilirubin no greater than 1.5 mg/dL
Transaminase no greater than 4 times upper limit of normal

Renal:

Creatinine clearance at least 40 mL/min

Cardiovascular:

No evidence of bifascicular block on EKG
No evidence of active ischemia on EKG
No prior history of transient ischemic attack
No evidence of congestive heart failure

Other:

No active peptic ulcer disease
No regular use of antacid or H2 blockers
No known or predicted achlorhydria
No concurrent use of terfenadine, astemizole, omeprazole, or cisapride
No second malignancy unless curatively treated
No history of deep venous thrombosis
No history of pulmonary embolism
No serious co-morbidity
HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior cytotoxic systemic therapy

Endocrine therapy:

Prior androgen deprivation therapy allowed if given for no more than 6 months to downstage primary
No androgen deprivation therapy within 1 year prior to study

Radiotherapy:

No prior cytotoxic systemic therapy (including systemic strontium-89 irradiation)
Prior definitive radiotherapy to the prostate and/or one metastatic site allowed
At least 8 weeks since radiotherapy to the pelvis
At least 3 weeks since radiotherapy to a single metastatic site

Surgery:

Prior prostatectomy allowed

Other:

No concurrent anti-anginal therapy or aggressive anticoagulants

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

306

Study ID:

NCT00002855

Recruitment Status:

Completed

Sponsor:

M.D. Anderson Cancer Center

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There is 1 Location for this study

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University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States

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Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

306

Study ID:

NCT00002855

Recruitment Status:

Completed

Sponsor:


M.D. Anderson Cancer Center

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