Trial · NCT00004124

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

NCT00004124, Phase 3, Completed, SWOG Cancer Research Network; results first posted 2018-09-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer. Trials, record NCT00004124. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00004124

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
NCT number: NCT00004124
Status: Completed
Phases: Phase 3
Enrollment: 983 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Prostate Cancer
Interventions: bicalutamide, goserelin, mitoxantrone hydrochloride, prednisone
First posted: 2003-01-27
Last updated: 2022-12-30
Results first posted: 2018-09-04

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival	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.
Primary	Disease Free Survival	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.
Secondary	Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients	Up to 22 months from registration	Number of patients with adverse events that are related to study drug
Secondary	PSA Progression Free Survival	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.
Secondary	PSA Progression as Surrogate Endpoint for Overall Survival or Disease Free Survival	Up to 10 Years

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival	at 10 Years		percentage of probability of survival	NUMBER
PRIMARY	Disease Free Survival	at 10 Years	Intent-to-treat	percentage of probability of survival	NUMBER
SECONDARY	Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients	Up to 22 months from registration	All eligible patients who received protocol therapy	Participants	NUMBER
SECONDARY	PSA Progression Free Survival	Up to 10 Years	Data for trial not collected for analysis.
SECONDARY	PSA Progression as Surrogate Endpoint for Overall Survival or Disease Free Survival	Up to 10 Years	Data not collected for analysis.

Source ClinicalTrials.gov

Results by group366

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Overall Survival	Arm I: Bicalutamide + Goserelin		87	percentage of probability of survival
Overall Survival	Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin		86	percentage of probability of survival
Disease Free Survival	Arm I: Bicalutamide + Goserelin		72	percentage of probability of survival
Disease Free Survival	Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin		72	percentage of probability of survival
Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients	Arm I: Bicalutamide + Goserelin	Abdominal pain/cramping	19	Participants
Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients	Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	Abdominal pain/cramping	41	Participants
Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients	Arm I: Bicalutamide + Goserelin	Abscess	0	Participants
Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients	Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	Abscess	1	Participants
Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients	Arm I: Bicalutamide + Goserelin	Alkaline phosphatase increase	11	Participants
Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients	Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	Alkaline phosphatase increase	11	Participants

1 to 10 of 366Source ClinicalTrials.gov

See all 366 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I: Bicalutamide + Goserelin	481
Overall Study	STARTED	Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	480
Overall Study	COMPLETED	Arm I: Bicalutamide + Goserelin	469
Overall Study	COMPLETED	Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	460
Overall Study	NOT COMPLETED	Arm I: Bicalutamide + Goserelin	12
Overall Study	NOT COMPLETED	Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	20

Source ClinicalTrials.gov

Adverse events126

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Arm I: Bicalutamide + Goserelin	6	469
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	23	460
other	Anemia	Blood and lymphatic system disorders	Arm I: Bicalutamide + Goserelin	71	469
other	Anemia	Blood and lymphatic system disorders	Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	152	460
other	Leukopenia	Investigations	Arm I: Bicalutamide + Goserelin	20	469
other	Leukopenia	Investigations	Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	319	460
other	Lymphopenia	Investigations	Arm I: Bicalutamide + Goserelin	8	469
other	Lymphopenia	Investigations	Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	51	460
other	Neutropenia/granulocytopenia	Investigations	Arm I: Bicalutamide + Goserelin	13	469
other	Neutropenia/granulocytopenia	Investigations	Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	240	460

1 to 10 of 126Source ClinicalTrials.gov

See all 126 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I: Bicalutamide + Goserelin	85	469
Total, all-cause mortality	Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	91	460
Total, other adverse events	Arm I: Bicalutamide + Goserelin	461	469
Total, other adverse events	Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	457	460
Total, serious adverse events	Arm I: Bicalutamide + Goserelin	3	469
Total, serious adverse events	Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	11	460

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
18349405	RESULT	PubMed
21502546	DERIVED	PubMed
29624463	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA032102	Southwest Oncology Group Treatment Grant	BLANKE, CHARLES D.	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm I: Bicalutamide + Goserelin vs Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin: deaths from any cause	Trial comparisons
Arm I: Bicalutamide + Goserelin vs Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00004124

GET https://conductscience.org/api/trials/v1/NCT00004124/results?page=2

API reference For AI assistants