AzTrials
AzTrials

Prostate CancerPhase 3NCT00004124

S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer

A Phase 3 study testing bicalutamide, goserelin and mitoxantrone hydrochloride in people with Prostate Cancer, run by SWOG Cancer Research Network at 234 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
bicalutamide, goserelin and mitoxantrone hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
983 participants
Where
234 sitesUnited States
Study dates
15 Oct 1999to 1 May 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

234 sites in 1 country.

234 sites in 1 country

United States234 sites

  • Cancer Care Institute of Carolina at Aiken Regional Medical Centers

    Aiken, South Carolina, 29801

  • Akron City Hospital

    Akron, Ohio, 44309-2090

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131-5636

  • Study site

    Alexandria, Minnesota, 56308

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Alaska Regional Hospital Cancer Center

    Anchorage, Alaska, 99508

  • Providence Cancer Center

    Anchorage, Alaska, 99508

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Fox Valley Hematology and Oncology - East Grant Street

    Appleton, Wisconsin, 54911-3496

  • MBCCOP - Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • Good Shepherd Hospital

    Barrington, Illinois, 60010

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • St. Charles Medical Center - Bend

    Bend, Oregon, 97701

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94704

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • St. Vincent Healthcare

    Billings, Montana, 59101

  • Billings Clinic Cancer Center

    Billings, Montana, 59107-5100

  • Deaconess Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Cancer Care Center at Medcenter One Hospital

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center

    Bismarck, North Dakota, 58502

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Brainerd Medical Center

    Brainerd, Minnesota, 56401

  • St. Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Veterans Affairs Medical Center - Brooklyn

    Brooklyn, New York, 11209

  • Community Hospitals and Wellness Centers - Bryan

    Bryan, Ohio, 43506

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • Peninsula Medical Center

    Burlingame, California, 94010

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • St. James Community Hospital

    Butte, Montana, 59701

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63701

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Cape Girardeau, Missouri, 63701

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Roper St. Francis Cancer Center at Roper Hospital

    Charleston, South Carolina, 29401

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • Veterans Affairs Medical Center - Lakeside Chicago

    Chicago, Illinois, 60611

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • Veterans Affairs Medical Center - Chicago Westside Hospital

    Chicago, Illinois, 60612

  • Mercy Hospital and Medical Center

    Chicago, Illinois, 60616

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Creticos Cancer Center at Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Memorial Hospital

    Colorado Springs, Colorado, 80909

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Evanston Northwestern Healthcare - Evanston Hospital

    Evanston, Illinois, 60201-1781

  • Oncology/Hematology Associates of Southwest Indiana at St. Mary's Cancer Center

    Evansville, Indiana, 47714

  • Study site

    Fergus Falls, Minnesota, 56537

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Banner Thunderbird Medical Center

    Glendale, Arizona, 85306

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Spectrum Health Hospital - Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Metro Health Hospital

    Grand Rapids, Michigan, 49506

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Sletten Regional Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology, Limited at St. Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • California Cancer Care, Incorporated

    Greenbrae, California, 94904

  • Marin Cancer Institute at Marin General Hospital

    Greenbrae, California, 94904

  • Sutter Health - Western Division Cancer Research Group

    Greenbrae, California, 94904

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, 08690

  • PinnacleHealth Regional Cancer Center at Polyclinic Hospital

    Harrisburg, Pennsylvania, 17105

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Veterans Affairs Medical Center - Hines

    Hines, Illinois, 60141

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • Community Oncology Group at Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Green Bay Oncology, Limited - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Foote Hospital

    Jackson, Michigan, 49201

  • Midwest Center for Hematology/Oncology

    Joliet, Illinois, 60432

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Kansas, 64128

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Kingsbury Center for Cancer Care at Cheshire Medical Center

    Keene, New Hampshire, 03431

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Lenoir Memorial Cancer Center

    Kinston, North Carolina, 28501

  • La Grange Memorial Hospital

    La Grange, Illinois, 60525

  • Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48909

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0293

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • North Shore Oncology and Hematology Associates, Limited - Libertyville

    Libertyville, Illinois, 60048

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Dean Medical Center - Madison

    Madison, Wisconsin, 53717

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Elliot Regional Cancer Center at Elliot Hospital

    Manchester, New Hampshire, 03103

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Louisiana State University Health Sciences Center - Monroe

    Monroe, Louisiana, 71210

  • Mountainside Hospital Cancer Center

    Montclair, New Jersey, 07042

  • Chippewa County - Montevideo Hospital

    Montevideo, Minnesota, 56265

  • Carol G. Simon Cancer Center at Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Hackley Hospital

    Muskegon, Michigan, 49442

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Cancer Care and Hematology Specialists of Chicagoland - Niles

    Niles, Illinois, 60714

  • Mid-Illinois Hematology-Oncology Associates at Community Cancer Center

    Normal, Illinois, 61761

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • OU Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Cancer Care Center at Advocate Lutheran Hospital

    Park Ridge, Illinois, 60068

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006

  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Legacy Emanuel Hospital and Health Center & Children's Hospital

    Portland, Oregon, 97227

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Frisbie Memorial Hospital

    Rochester, New Hampshire, 03867

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Seton Cancer Institute - Saginaw

    Saginaw, Michigan, 48601

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • Naval Medical Center - San Diego

    San Diego, California, 92134

  • San Francisco General Hospital Medical Center

    San Francisco, California, 94110

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • California Pacific Medical Center - California Campus

    San Francisco, California, 94118

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • Cancer Center of Santa Barbara

    Santa Barbara, California, 93105

  • Sansum Medical Clinic

    Santa Barbara, California, 93105

  • Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara

    Santa Barbara, California, 93105

  • Adult and Pediatric Urology, P.L.L.P.

    Sartell, Minnesota, 56377

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • North Puget Oncology at United General Hospital

    Sedro-Woolley, Washington, 98284

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana, 71101

  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences

    Shreveport, Louisiana, 71130-3932

  • Hematology Oncology Associates - Skokie

    Skokie, Illinois, 60076

  • Hematology/Oncology of the North Shore at Gross Point Medical Center

    Skokie, Illinois, 60076

  • Santa Barbara Hematology Oncology - Solvang

    Solvang, California, 93463

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Rockwood Clinic Cancer Treatment Center

    Spokane, Washington, 99204-2967

  • Highlands Oncology Group - Springdale

    Springdale, Arkansas, 72764

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • Arch Medical Services, Incorporated at Center for Cancer Care Research

    St Louis, Missouri, 63141

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Carl and Dorothy Bennett Cancer Center at Stamford Hospital

    Stamford, Connecticut, 06904

  • Green Bay Oncology, Limited - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Madigan Army Medical Center - Tacoma

    Tacoma, Washington, 98431

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Sutter Solano Medical Center

    Vallejo, California, 94589

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington, 98668

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Cedar Valley Medical Specialists, PC - West Ridgeway Avenue

    Waterloo, Iowa, 50702

  • Covenant Cancer Treatment Center

    Waterloo, Iowa, 50702

  • University of Wisconcin Cancer Center at Aspirus Wausau Hospital

    Wausau, Wisconsin, 54401

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Cleveland Clinic - Wooster

    Wooster, Ohio, 44691

  • Commonwealth Hematology-Oncology P.C. - Worcester

    Worcester, Massachusetts, 01605

  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

  • Tod Children's Hospital - Forum Health

    Youngstown, Ohio, 44501

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
bicalutamide, goserelin, mitoxantrone hydrochloride, prednisone
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bicalutamideDrug

    Also called Casodex

  • goserelinDrug

    Also called Zoladex

  • mitoxantrone hydrochlorideDrug

  • prednisoneDrug

Study groups in NCT00004124
Study groupRoleWhat they receive
bicalutamide, goserelinActive comparatorandrogen deprivation
Receives: Drug: bicalutamide; Drug: goserelin
bicalutamide, goserelin, mitoxantrone, prednisoneExperimentalandrogen deprivation plus mitoxantrone, prednisone
Receives: Drug: bicalutamide; Drug: goserelin; Drug: mitoxantrone hydrochloride; Drug: prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured from date of randomization to date of death from any cause. Patient known to be alive are censored at date of last contact.

    Measured: at 10 Years

  2. Disease Free Survival

    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.

    Measured: at 10 Years

Secondary outcomes (3)

  1. Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients

    Number of patients with adverse events that are related to study drug

    Measured: Up to 22 months from registration

  2. PSA Progression Free Survival

    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.

    Measured: Up to 10 Years

  3. PSA Progression as Surrogate Endpoint for Overall Survival or Disease Free Survival

    Measured: Up to 10 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study start15 Oct 1999
  3. Primary completion12 Aug 2017
  4. Study completion1 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
983 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004124
Sponsor's protocol ID
CDR0000067352
Other IDs
S9921, CALGB-99904, U10CA032102
Status last verified
Dec 2022
First submitted
10 Dec 1999
Last updated
30 Dec 2022
Data monitoring committee
Yes

Publications

  • Glode LM, Tangen CM, Hussain MH, et al.: Southwest Oncology Group S9921: prolonged event-free survival in high-risk prostate cancer (PC) patients receiving adjuvant androgen deprivation. [Abstract] J Clin Oncol 27 (Suppl 15): A-5009, 2009.

  • Flaig TW, Tangen CM, Hussain MH, Stadler WM, Raghavan D, Crawford ED, Glode LM; Southwest Oncology Group. Randomization reveals unexpected acute leukemias in Southwest Oncology Group prostate cancer trial. J Clin Oncol. 2008 Mar 20;26(9):1532-6. doi: 10.1200/JCO.2007.13.4197.

    PubMed 18349405

  • Glode LM, Hussain MH, Benson MC, et al.: SWOG 9921: a phase III multi-institutional trial of adjuvant therapy for high risk prostate cancer after radical prostatectomy. [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-349, 2007.

  • Hussain M, Tangen CM, Thompson IM Jr, Swanson GP, Wood DP, Sakr W, Dawson NA, Haas NB, Flaig TW, Dorff TB, Lin DW, Crawford ED, Quinn DI, Vogelzang NJ, Glode LM. Phase III Intergroup Trial of Adjuvant Androgen Deprivation With or Without Mitoxantrone Plus Prednisone in Patients With High-Risk Prostate Cancer After Radical Prostatectomy: SWOG S9921. J Clin Oncol. 2018 May 20;36(15):1498-1504. doi: 10.1200/JCO.2017.76.4126. Epub 2018 Apr 6.

    PubMed 29624463

  • Dorff TB, Flaig TW, Tangen CM, Hussain MH, Swanson GP, Wood DP Jr, Sakr WA, Dawson NA, Haas NB, Crawford ED, Vogelzang NJ, Thompson IM, Glode LM. Adjuvant androgen deprivation for high-risk prostate cancer after radical prostatectomy: SWOG S9921 study. J Clin Oncol. 2011 May 20;29(15):2040-5. doi: 10.1200/JCO.2010.32.2776. Epub 2011 Apr 18.

    PubMed 21502546

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bicalutamide, goserelin and mitoxantrone hydrochloride in people with Prostate Cancer, run by SWOG Cancer Research Network at 234 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 234 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: at 10 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00004124, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in