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Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer

Registration Number
NCT00030654
Lead Sponsor
Radiation Therapy Oncology Group
Brief Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as luteinizing hormone-releasing hormone agonist, flutamide, and bicalutamide may stop the adrenal glands from producing androgens. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy given at the same time as hormone therapy is more effective than chemotherapy given after hormone therapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given at the same time as hormone therapy with that of chemotherapy given after hormone therapy in treating patients who have prostate cancer.

Detailed Description

OBJECTIVES:

Primary

* Compare the survival of patients with high-risk hormone-naive prostate cancer treated with androgen blockade with concurrent chemotherapy vs delayed chemotherapy.

Secondary

* Compare biochemical control in patients treated with these regimens.

* Determine the toxicity of these regimens in these patients.

* Compare the time to clinical failure, as measured by progression on bone scan or CT scan or a prostate-specific antigen (PSA) doubling time of ≤ 32 weeks, in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior therapy (surgery vs radiotherapy and/or brachytherapy vs both), original combined Gleason score (6 vs 7 vs 8-10), and prior vaccine therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive androgen blockade (AB) comprising a luteinizing-hormone releasing-hormone agonist continuously and oral flutamide or oral bicalutamide once daily for at least 1 month. Within 4 weeks of initiation of AB, patients begin chemotherapy. Patients receive 1, and only 1, of the following chemotherapy regimens:

* Regimen A: Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV on day 3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

* Regimen B: Patients receive oral estramustine 3 times daily on days 1-5 and paclitaxel IV on days 3, 10, 17, 24, 31, and 38. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity.

* Regimen C: Patients receive oral ketoconazole 3 times daily on days 1-7, 15-21, and 29-35; doxorubicin IV on days 1, 15, and 29; vinblastine IV on days 8, 22, and 36; and oral estramustine 3 times daily on days 8-14, 22-28, and 36-42. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity.

* Regimen D: Patients receive oral estramustine 3 times daily on days 1-4 and docetaxel IV over 1 hour on days 3, 10, and 17. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

* Regimen E: Patients receive docetaxel IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

* Regimen F: Patients receive docetaxel IV on days 1, 8, and 15. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

* Regimen G: With approval from the protocol chair, patients may receive a regimen that has been demonstrated in a published phase II study to have at least a 50% response rate as measured by PSA decrease from baseline over 2 measurements 28 days apart or a decrease in measurable soft tissue disease by 50% in 2 dimensions.

* Arm II: Patients receive AB as in arm I. Patients continue with AB until clinical failure, at which time patients receive chemotherapy as in arm I. Patients who have a response may continue to receive chemotherapy beyond 4 courses.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,050 patients will be accrued for this study within 4-6 years.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
21
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Androgen blockade + immediate chemotherapydocetaxelAndrogen blockade with immediate chemotherapy
Androgen blockade + immediate chemotherapydoxorubicin hydrochlorideAndrogen blockade with immediate chemotherapy
Androgen blockade + immediate chemotherapyketoconazoleAndrogen blockade with immediate chemotherapy
Androgen blockade + immediate chemotherapybicalutamideAndrogen blockade with immediate chemotherapy
Androgen blockade + immediate chemotherapyestramustine phosphate sodiumAndrogen blockade with immediate chemotherapy
Androgen blockade + immediate chemotherapyflutamideAndrogen blockade with immediate chemotherapy
Androgen blockade + immediate chemotherapypaclitaxelAndrogen blockade with immediate chemotherapy
Androgen blockade + immediate chemotherapyreleasing hormone agonist therapyAndrogen blockade with immediate chemotherapy
Androgen blockade + immediate chemotherapyvinblastine sulfateAndrogen blockade with immediate chemotherapy
Androgen blockade + delayed chemotherapybicalutamideAndrogen blockade with delayed chemotherapy
Androgen blockade + delayed chemotherapydocetaxelAndrogen blockade with delayed chemotherapy
Androgen blockade + delayed chemotherapydoxorubicin hydrochlorideAndrogen blockade with delayed chemotherapy
Androgen blockade + delayed chemotherapyflutamideAndrogen blockade with delayed chemotherapy
Androgen blockade + delayed chemotherapyestramustine phosphate sodiumAndrogen blockade with delayed chemotherapy
Androgen blockade + delayed chemotherapypaclitaxelAndrogen blockade with delayed chemotherapy
Androgen blockade + delayed chemotherapyreleasing hormone agonist therapyAndrogen blockade with delayed chemotherapy
Androgen blockade + delayed chemotherapyvinblastine sulfateAndrogen blockade with delayed chemotherapy
Androgen blockade + delayed chemotherapyketoconazoleAndrogen blockade with delayed chemotherapy
Primary Outcome Measures
NameTimeMethod
Overall SurvivalFrom date of randomization to the date of death due to any cause
Secondary Outcome Measures
NameTimeMethod
Biochemical controlFrom date of randomization to the date of first PSA failure defined as a PSA doubling time <= 32 weeks
Time to Clinical FailureTime from study entry to positive scan or positive disease evaluation of the pelvis or chest or a PSA doubling time ≤ 32 weeks
Frequency of non-hematologic (>= grade 3), hematologic (grade >=4) and fatal (grade 5) toxicitiesFrom the beginning of treatment to 90 days post treatment

Trial Locations

Locations (78)

Foundation for Cancer Research and Education

🇺🇸

Phoenix, Arizona, United States

Veterans Affairs Medical Center - Tucson

🇺🇸

Tucson, Arizona, United States

Veterans Affairs Medical Center - Little Rock

🇺🇸

Little Rock, Arkansas, United States

Veterans Affairs Outpatient Clinic - Martinez

🇺🇸

Martinez, California, United States

Medical Center of Aurora - South Campus

🇺🇸

Aurora, Colorado, United States

Boulder Community Hospital

🇺🇸

Boulder, Colorado, United States

Memorial Hospital Cancer Center

🇺🇸

Colorado Springs, Colorado, United States

Penrose Cancer Center at Penrose Hospital

🇺🇸

Colorado Springs, Colorado, United States

Porter Adventist Hospital

🇺🇸

Denver, Colorado, United States

St. Joseph Hospital

🇺🇸

Denver, Colorado, United States

Scroll for more (68 remaining)
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States

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