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NCT00004124

S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer

Last Updated: 2022-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

983 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-15

Study Completion Date

2018-05-01

Brief Summary

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RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus mitoxantrone and prednisone is more effective than hormone therapy alone for prostate cancer.

PURPOSE: This randomized phase III trial is studying hormone therapy, mitoxantrone, and prednisone to see how well they work compared to hormone therapy alone in treating patients who have undergone radical prostatectomy for prostate cancer.

Detailed Description

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OBJECTIVES:

* Compare the overall and disease-free survival of patients with high-risk adenocarcinoma of the prostate treated with adjuvant androgen deprivation therapy with or without mitoxantrone and prednisone after radical prostatectomy.
* Compare the qualitative and quantitative toxic effects of these regimens in this patient population.
* Compare the prostate-specific antigen (PSA) progression-free survival rate in patient treated with these regimens.
* Determine whether PSA progression is a surrogate endpoint for survival or disease-free survival in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to surgical extent of disease (organ confined vs not organ confined, but N0 vs N1), Gleason's sum (less than 7 vs 7 vs greater than 7), and planned radiotherapy (yes vs no). Patients are randomized to one of two treatment arms.

* Arm I:Patients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity.
* Arm II:Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.

Patients may undergo radiotherapy 5 days a week for 6.5-7.8 weeks beginning anytime (arm I) or after completion of chemotherapy (arm II), at the discretion of the physician, in the absence of disease progression or unacceptable toxicity.

Patients are offered the possibility to participate in biomarker research by allowing their tissue/blood to be studied.

Patients are followed every 6 months for 2 years and then annually for up to 13 years.

PROJECTED ACCRUAL: A total of 1,360 patients (680 per treatment arm) will be accrued for this study within 9.5 years.

Conditions

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Prostate Cancer

Keywords

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adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer stage III prostate cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bicalutamide, goserelin

androgen deprivation

Group Type ACTIVE_COMPARATOR

bicalutamide

Intervention Type DRUG

goserelin

Intervention Type DRUG

bicalutamide, goserelin, mitoxantrone, prednisone

androgen deprivation plus mitoxantrone, prednisone

Group Type EXPERIMENTAL

bicalutamide

Intervention Type DRUG

goserelin

Intervention Type DRUG

mitoxantrone hydrochloride

Intervention Type DRUG

prednisone

Intervention Type DRUG

Interventions

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bicalutamide

Intervention Type DRUG

goserelin

Intervention Type DRUG

mitoxantrone hydrochloride

Intervention Type DRUG

prednisone

Intervention Type DRUG

Other Intervention Names

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Casodex Zoladex

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed stage T1-T3 adenocarcinoma of the prostate before radical prostatectomy and lymph node dissection

* Must have undergone prostatectomy within the past 120 days
* Must meet at least 1 of the following pathologic criteria:

* Gleason sum at least 8
* pT3b (seminal vesicle), pT4, or N1
* Gleason sum of 7 and positive margin
* Preoperative PSA greater than 15 ng/mL, Gleason score greater than 7, or PSA level greater than 10 ng/mL and Gleason score greater than 6
* Must have an undetectable PSA (no greater than 0.2 ng/mL) documented after surgery or prior to adjuvant hormonal therapy (for patients initiating adjuvant hormonal therapy prior to study)
* No evidence of metastatic disease on bone scan if PSA is 20 ng/mL or greater at clinical diagnosis
* No distant metastatic disease

PATIENT CHARACTERISTICS:

Performance status:

* SWOG 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Cardiovascular:

* No uncontrolled congestive heart failure
* If history of cardiac disease, LVEF at least 50% by MUGA scan or 2-D echocardiogram

Other:

* No HIV positivity
* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer that is currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Prior neoadjuvant hormonal therapy of no more than 4 months duration before radical prostatectomy allowed
* Other concurrent adjuvant hormonal therapy allowed if initiated prior to study
* Concurrent low-dose megestrol (less than 40 mg/day) for hot flashes allowed

Radiotherapy:

* No prior radiotherapy
* No concurrent whole pelvis irradiation
* Concurrent radiotherapy allowed at the discretion of the physician

Surgery:

* See Disease Characteristics
* See Endocrine therapy
* Recovered from prior surgery

Other:

* No other prior or concurrent therapy for adenocarcinoma of the prostate

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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L. Michael Glode, MD

Role: STUDY_CHAIR

University of Colorado, Denver

Nancy A. Dawson, MD

Role: STUDY_CHAIR

University of Maryland Greenebaum Cancer Center

Locations

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Alaska Regional Hospital Cancer Center

Anchorage, Alaska, United States

Site Status

Providence Cancer Center

Anchorage, Alaska, United States

Site Status

Banner Thunderbird Medical Center

Glendale, Arizona, United States

Site Status

Banner Good Samaritan Medical Center

Phoenix, Arizona, United States

Site Status

CCOP - Western Regional, Arizona

Phoenix, Arizona, United States

Site Status

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Highlands Oncology Group - Springdale

Springdale, Arkansas, United States

Site Status

Alta Bates Comprehensive Cancer Center

Berkeley, California, United States

Site Status

Peninsula Medical Center

Burlingame, California, United States

Site Status

California Cancer Care, Incorporated

Greenbrae, California, United States

Site Status

Marin Cancer Institute at Marin General Hospital

Greenbrae, California, United States

Site Status

Sutter Health - Western Division Cancer Research Group

Greenbrae, California, United States

Site Status

Naval Medical Center - San Diego

San Diego, California, United States

Site Status

San Francisco General Hospital Medical Center

San Francisco, California, United States

Site Status

UCSF Comprehensive Cancer Center

San Francisco, California, United States

Site Status

California Pacific Medical Center - California Campus

San Francisco, California, United States

Site Status

Veterans Affairs Medical Center - San Francisco

San Francisco, California, United States

Site Status

Cancer Center of Santa Barbara

Santa Barbara, California, United States

Site Status

Sansum Medical Clinic

Santa Barbara, California, United States

Site Status

Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara

Santa Barbara, California, United States

Site Status

Santa Barbara Hematology Oncology - Solvang

Solvang, California, United States

Site Status

Sutter Solano Medical Center

Vallejo, California, United States

Site Status

Memorial Hospital

Colorado Springs, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Site Status

Carl and Dorothy Bennett Cancer Center at Stamford Hospital

Stamford, Connecticut, United States

Site Status

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

MBCCOP - Medical College of Georgia Cancer Center

Augusta, Georgia, United States

Site Status

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Site Status

Tripler Army Medical Center

Honolulu, Hawaii, United States

Site Status

Saint Anthony's Hospital at Saint Anthony's Health Center

Alton, Illinois, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status