S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00004124|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Results First Posted : September 3, 2018
Last Update Posted : June 6, 2019
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: bicalutamide Drug: goserelin Drug: mitoxantrone hydrochloride Drug: prednisone||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||983 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High-Risk Prostate Cancer Patients Following Radical Prostatectomy|
|Study Start Date :||October 1999|
|Actual Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 1, 2022|
Active Comparator: bicalutamide, goserelin
Other Name: Casodex
Other Name: Zoladex
Experimental: bicalutamide, goserelin, mitoxantrone, prednisone
androgen deprivation plus mitoxantrone, prednisone
Other Name: Casodex
Other Name: Zoladex
Drug: mitoxantrone hydrochloride
- Overall Survival [ Time Frame: at 10 Years ]Measured from date of randomization to date of death from any cause. Patient known to be alive are censored at date of last contact.
- Disease Free Survival [ Time Frame: at 10 Years ]Measured from date of randomization to date of first observation of recurrence or death due to any cause. Patients without recurrence are censored at date of last contact.
- Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients [ Time Frame: Up to 22 months from registration ]Number of patients with adverse events that are related to study drug
- PSA Progression Free Survival [ Time Frame: Up to 10 Years ]Measured from date of randomization to date of PSA progression or death due to any cause. PSA progression is defined as a serum PSA level of > 0.2 ng/mL measured on 3 consecutive occasions or in the absence of increasing PSA, a positive bone scan result or other radiographic or histologic evidence of progression will be used. Date of progression will be the date that the first measure of increasing PSA is noted in the series of 3.
- PSA Progression as Surrogate Endpoint for Overall Survival or Disease Free Survival [ Time Frame: Up to 10 Years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004124
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|Study Chair:||L. Michael Glode, MD||University of Colorado, Denver|
|Study Chair:||Nancy A. Dawson, MD||University of Maryland Greenebaum Cancer Center|