SWOG clinical trial number
S9921
Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High Risk Prostate Cancer Patients Following Radical Prostatectomy, Phase III.
Closed
Phase
Accrual
72%
Abbreviated Title
Local Prostate
Activated
10/15/1999
Closed
01/12/2007
Participants
NCORP, Members, UCOP, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, CALGB, EPP, CTSU Institutions in the United States, Affiliates
Research committees
Genitourinary Cancer
Treatment
Prednisone
Bicalutamide
Mitoxantrone
Goserelin Acetate
Eligibility Criteria Expand/Collapse
Pt must have a histologic diagnosis of adenocarcinoma of the prostate and be considered to have clinically localized disease (Stage T1-T3, N0, M0) and be considered operable for cure. Pts must have had a radical prostatectomy (RP) w/in 120 days prior to reg and fulfill one or more of the following: pathologic Gleason's sum of greater than or equal to 8; pT3b (seminal vesicle) or pT4 or N1; Gleason's sum of 7 and positive margin; or preop PSA of > 15 ng/ml or biopsy Gleason > 7 or PSA > 10 ng/ml and biopsy Gleason > 6. Serum testosterone must be obtained w/in 28 days prior to registration. Pt must have a PS of 0-1. Prior neoadj therapy of less than/equal to 4 mos prior to RP is allowed provided pt fulfilled clinical eligibility prior to hormonal treatment. Pts may have started hormonal therapy post-prostatectomy but prior to reg to this study. No other therapy aimed at the tx of this diagnosis may have been given or may be planned while pt is rec'g protocol tx. Use of low dose megace for tx of hot flashes is allowed. Pts must not have rec'd prior RT. If physician wishes to admin RT, Pt should be registered 1st and then optional RT given on protocol. Pts PSA must be w/in the guidelines and timeframes noted in Section 5.5. Institutional path report documenting eligibility must be available for submission. All pts registered on or after 6/15/06 must be offered the opportunity to consent for specimen banking per Section 15. Pts with PSA at clinical diagnosis greater than/equal 20 ng/ml must have bone scan not suggestive of metastatic disease w/in 180 days prior to reg. Pts w/symptoms of distant mets must have appropriate tests to evaluate for met disease w/in 56 days prior to reg. Pts with confirmed distant mets are ineligible. Pts must have baseline EKG w/in 42 days prior to reg. Pts w/history of cardiac disease (CHF) are ineligible unless their disease is well-controlled and they have LVEF greater than/equal to 50% by MUGA or 2-d echo w/in 42 days prior to reg. Pts known to be HIV + are not eligible.
Publication Information Expand/Collapse
2018
PMid: PMID29624463 | PMC number: PMC5959197
2017
2011
Adjuvant androgen deprivation for high-risk prostate cancer after radical prostatectomy: SWOG S9921 study [PMID21502546; PMC3107759]
2010
Southwest Oncology Group study 9921: prolonged event free survival in high risk prostate cancer (PC) patients receiving adjuvant androgen deprivation
2009
Southwest Oncology Group S9921: prolonged event free survival in high risk prostate cancer (PC) patients receiving adjuvant androgen deprivation.
Biased hormonal therapy duration analysis makes results uninterpretable [PMID19786655]
2008
Randomization reveals unexpected acute leukemias in SWOG prostate cancer trial [PMID 18349405]
Interim futility analysis with intermediate endpoints
PMid: PMID18283075
Other Clinical Trials
SWOG Clinical Trial Number
S2210
S2210, "Targeted Neoadjuvant Treatment for Patients with Localized Prostate Cancer and Germline DNA Repair Deficiency"
Research Committee(s)
Genitourinary Cancer
Activated
08/14/2023
Accrual
2%
Open
Phase
SWOG Clinical Trial Number
S2200
S2200, A Phase II Randomized Trial of Cabozantinib with or Without Atezolizumab in Patients with Advanced Papillary Renal Cell Carcinoma: PAPMET2
Research Committee(s)
Genitourinary Cancer
Activated
09/19/2022
Accrual
8%
Open
Phase
SWOG Clinical Trial Number
CTSU/A031901
Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: A Randomized Phase 3 Non-Inferiority Trial
Research Committee(s)
Genitourinary Cancer
Activated
05/01/2021
Open
Phase