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Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High-Risk Prostate Cancer Patients Following Radical Prostatectomy

Unique Dataset IDNCT00004124
SponsorSouthwest Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients0RandomizationYesPubMed (PMID)29624463.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeDrugDataset TypeOther

NCI Description

The NCT00004124-D2 Dataset will allow users to reproduce the toxicity results reported in the Journal of Clinical Oncology (Hussain et al., JCO, 2015, PMID referenced above) for trial NCT00004124.

Clinical Trial Title

Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High-Risk Prostate Cancer Patients Following Radical Prostatectomy

Trial Summary and Conditions

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.

Data Summary

See data dictionary for more details.

Study Objectives

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.

Outcome Measures

Primary: Overall Survival [ Time Frame: at 10 Years ] Disease Free Survival [ Time Frame: at 10 Years ] Secondary: Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients [ Time Frame: Up to 22 months from registration ] PSA Progression Free Survival [ Time Frame: Up to 10 Years ] PSA Progression as Surrogate Endpoint for Overall Survival or Disease Free Survival [ Time Frame: Up to 10 Years ]

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

Available Downloads:

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00004124-D2-Data-Dictionary_2.pdf

DATA: NCT00004124-D2-Dataset_2.csv