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.

72% Accrual

Accrual

72%

Closed

Phase

72% Accrual

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

A Phase III IntergroupTrial of Adjuvant Androgen Deprivation +/- Mitoxantrone + Prednisone in Patients with High-Risk Prostate Cancer Post-Radical Prostatectomy: SWOG S9921

M Hussain;C Tangen;I Thompson;G Swanson;DP Wood;W Sakr;N Dawson;N Haas;T Flaig;T Dorff;DW Lin;ED Crawford;DI Quinn;N Vogelzang Journal of Clinical Oncology May 20;36(15):1498-1504; Apr 6 [Epub ahead of print]

PMid: PMID29624463 | PMC number: PMC5959197

2017

Adjuvant Androgen Deprivation (ADT) Versus Mitoxantrone Plus Prednisone (MP) Plus ADT in High Risk Prostate Cancer (PCa)Patients Following Radical Prostatectomy: A Phase III Intergroup Trial (SWOG S9921) NCT00004124

LM Glode;CM Tangen;M Hussain;GP Swanson;DP Wood;W Sakr;NA Dawson;NB Haas;TW Flaig;TB Dorff;DW Lin;ED Crawford;DI Quinn;NJ Vogelzang;IM Thompson Journal of Clinical Oncology 35, 2017(suppl 6S; abstract 2); ASCO GU Cancers Symposium (February16-18, 2017, Orlando, FL), oral

Adjuvant androgen deprivation (AD) +mitoxantrone + prednisone (MP) in high risk prostate cancer (PC) patients post radical prostatectomy (RP): phase III intergroup trial S9921

M Hussain;C Tangen;IM Thompson;G Swanson;DP Wood;W Sakr;NA Dawson;NB Haas;TW Flaig;T Dorff;D Lin;ED Crawford;DI Quinn;N Vogelzang;LM Glode J Clin Oncol 35, 2017 (suppl; abstr 5019); American Society of Clinical Oncology Annual Meeting (June 2-6, 2017, Chicago, IL), poster discussion

2011

Adjuvant androgen deprivation for high-risk prostate cancer after radical prostatectomy: SWOG S9921 study [PMID21502546; PMC3107759]

T Dorff;T Flaig;C Tangen;MHA Hussain;G Swanson;DP Wood, Jr;W Sakr;N Dawson;N Haas;ED Crawford;NJ Vogelzang;IM Thompson;LM Glode Journal of Clinical Oncology 29(15)2040-2045;

2010

Southwest Oncology Group study 9921: prolonged event free survival in high risk prostate cancer (PC) patients receiving adjuvant androgen deprivation

IM Thompson;CM Tangen;MHA Hussain;DP Wood;G Swanson;DI Quinn;TB Dorff;NA Dawson;NB Haas;ED Crawford;LM Glode American Urological Association 2010 Meeting; late breaking; oral

2009

Southwest Oncology Group S9921: prolonged event free survival in high risk prostate cancer (PC) patients receiving adjuvant androgen deprivation.

LM Glode;CM Tangen;MHA Hussain;DP Wood;GP Swanson;N Dawson;N Balzer-Haas;DI Quinn;ED Crawford;IM Thompson Journal of Clinical Oncology 27:15s, abst.#5009

Biased hormonal therapy duration analysis makes results uninterpretable [PMID19786655]

CM Tangen;BH Goldman;GP Swanson;IM Thompson Journal of Clinical Oncology 27(33):e203

2008

Randomization reveals unexpected acute leukemias in SWOG prostate cancer trial [PMID 18349405]

TW Flaig;CM Tangen;MHA Hussain;WM Stadler;D Raghavan;ED Crawford;LM Glode Journal of Clinical Oncology 26(9)1532-1536

Interim futility analysis with intermediate endpoints

B Goldman;M LeBlanc;J Crowley Clinical Trials 5(1):14-22

PMid: PMID18283075

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