S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: bicalutamide Drug: goserelin Drug: mitoxantrone hydrochloride Drug: prednisone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High-Risk Prostate Cancer Patients Following Radical Prostatectomy |
- Overall survival [ Time Frame: at month 4 and every 3 months for 2 years ] [ Designated as safety issue: No ]
- Disease-free survival [ Time Frame: at month 4 and every 3 months for 2 years ] [ Designated as safety issue: No ]
- Qualitative and quantitative toxicity [ Time Frame: every 21 days for 4 months, then every 3 months for 2 years ] [ Designated as safety issue: Yes ]
- Prostate-specific antigen (PSA) progression-free survival rate [ Time Frame: at month 4 and every 3 months for 2 years ] [ Designated as safety issue: No ]
- Evaluation of biomarkers [ Time Frame: prestudy, weeks 24 and 28, and at progression ] [ Designated as safety issue: No ]
| Enrollment: | 983 |
| Study Start Date: | October 1999 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: bicalutamide, goserelin
androgen deprivation
|
Drug: bicalutamide
Other Name: Casodex
Drug: goserelin
Other Name: Zoladex
|
|
Experimental: bicalutamide, goserelin, mitoxantrone, prednisone
androgen deprivation plus mitoxantrone, prednisone
|
Drug: bicalutamide
Other Name: Casodex
Drug: goserelin
Other Name: Zoladex
Drug: mitoxantrone hydrochloride
Drug: prednisone
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 234 Study Locations| Study Chair: | L. Michael Glode, MD | University of Colorado, Denver |
| Study Chair: | Nancy A. Dawson, MD | University of Maryland Greenebaum Cancer Center |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00004124 History of Changes |
| Other Study ID Numbers: | CDR0000067352, S9921, CALGB-99904, U10CA032102 |
| Study First Received: | December 10, 1999 |
| Last Updated: | October 3, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer stage III prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Androgens Bicalutamide Mitoxantrone Prednisone Goserelin Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Glucocorticoids Antineoplastic Agents, Hormonal Anti-Inflammatory Agents Androgen Antagonists Hormone Antagonists |
ClinicalTrials.gov processed this record on May 21, 2013