Trial · NCT00002651

SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer

NCT00002651, Phase 3, Completed, SWOG Cancer Research Network; results first posted 2017-04-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer. Trials, record NCT00002651. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00002651

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Trial

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

Title: SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer
NCT number: NCT00002651
Status: Completed
Phases: Phase 3
Enrollment: 3,040 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Prostate Cancer
Interventions: bicalutamide, goserelin acetate, clinical observation
First posted: 2003-01-27
Last updated: 2017-04-17
Results first posted: 2017-04-17

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	Overall Survival	Up to 15 years	Non-inferiority test to determine if intermittent combined androgen deprivation (CAD) overall survival is not substantially worse than continuous CAD overall survival. Specifically, the trial is designed for a one-sided test of the hypothesis that the hazard ratio of intermittent CAD to continuous CAD is 1.2. The assumptions used to compute the trial size are an overall type I error rate of 0.05 and a type II error of 0.10 (power = 0.9).
Primary	Physical Functioning as Measured by the SF-36	3 months	This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. Change from Baseline in SF-36 Score at 3 Months
Primary	Emotional Functioning as Measured by the SF-36 Mental Health Inventory	3 months	This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. Change from Baseline in SF-36 Score at 3 Months
Primary	Erectile Dysfunction	3 months	This outcome was assessed by having patients report whether they had erectile dysfunction (a score of 1) or no erectile dysfunction (a score of 0). This analysis looks at change from Baseline to 3 Months.
Primary	High Libido	3 months	This outcome was assessed by having patients report whether their interest in sexual activities was very high, high, or moderate (a score of 1) or low or very low (a score of 0). This outcome measure is reporting a change from baseline in the percentage of participants with High Libido at 3 months. "High Libido" is defined as very high, high or moderate interest in sexual activities.
Primary	Vitality	3 months	This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. This analysis looks at mean change from Baseline score to 3 Months.
Other	Global Perception of Quality of Life	15 months
Other	Social Functioning	15 months	Mean of the change in social functioning from randomization
Other	Role Functioning	15 months	Mean of the change in role functioning from randomization
Other	General Symptoms	15 months

Source ClinicalTrials.gov

Outcomes10

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival	Up to 15 years		years	MEDIAN
PRIMARY	Physical Functioning as Measured by the SF-36	3 months	Only eligible patients with a usable form set for Physical Functioning portion of the SF-36 both at baseline and 3 months were included in this analysis.	units on a scale	MEAN
PRIMARY	Emotional Functioning as Measured by the SF-36 Mental Health Inventory	3 months	Only eligible patients with a usable form set for SF-36 Mental Health Inventory both at baseline and 3 months were included in this analysis.	units on a scale	MEAN
PRIMARY	Erectile Dysfunction	3 months	Only eligible patients with a usable answers regarding erectile dysfunction both at baseline and 3 months were included in this analysis.	percentage of participants	NUMBER
PRIMARY	High Libido	3 months	Only eligible patients with a usable answers regarding libido both at baseline and 3 months were included in this analysis.	percentage of participants	NUMBER
PRIMARY	Vitality	3 months	Only eligible patients with a usable form set for Vitality both at baseline and 3 months were included in this analysis.	units on a scale	MEAN
OTHER_PRE_SPECIFIED	Global Perception of Quality of Life	15 months
OTHER_PRE_SPECIFIED	Social Functioning	15 months
OTHER_PRE_SPECIFIED	Role Functioning	15 months
OTHER_PRE_SPECIFIED	General Symptoms	15 months

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Spread	Units
Overall Survival	Consolidation Arm I	5.8	95% Confidence Interval 5.3 to 6.4	years
Overall Survival	Consolidation Arm II	5.1	95% Confidence Interval 4.8 to 5.5	years
Physical Functioning as Measured by the SF-36	Continuous Hormonal Therapy	-1.74	Standard Error 0.7366	units on a scale
Physical Functioning as Measured by the SF-36	Intermittent Hormonal Therapy	0.09	Standard Error 0.8084	units on a scale
Emotional Functioning as Measured by the SF-36 Mental Health Inventory	Continuous Hormonal Therapy	-0.95	Standard Error 0.6804	units on a scale
Emotional Functioning as Measured by the SF-36 Mental Health Inventory	Intermittent Hormonal Therapy	1.92	Standard Error 0.7241	units on a scale
Erectile Dysfunction	Continuous Hormonal Therapy	2		percentage of participants
Erectile Dysfunction	Intermittent Hormonal Therapy	-7		percentage of participants
High Libido	Continuous Hormonal Therapy	-2		percentage of participants
High Libido	Intermittent Hormonal Therapy	16		percentage of participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow30

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

Period	Milestone	Group	Participants
Induction	STARTED	Combined Androgen Deprivation (CAD)	3,040
Induction	STARTED	Continuous Hormonal Therapy	0
Induction	STARTED	Intermittent Hormonal Therapy	0
Induction	Eligible	Combined Androgen Deprivation (CAD)	2,950
Induction	Eligible	Continuous Hormonal Therapy	0
Induction	Eligible	Intermittent Hormonal Therapy	0
Induction	Eligible and Began Protocol Therapy	Combined Androgen Deprivation (CAD)	2,950
Induction	Eligible and Began Protocol Therapy	Continuous Hormonal Therapy	0
Induction	Eligible and Began Protocol Therapy	Intermittent Hormonal Therapy	0
Induction	COMPLETED	Combined Androgen Deprivation (CAD)	1,697

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events80

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	Anemia	Blood and lymphatic system disorders	Continuous Hormonal Therapy	86	732
other	Anemia	Blood and lymphatic system disorders	Intermittent Hormonal Therapy	85	702
other	Constipation/bowel obstruction	Gastrointestinal disorders	Continuous Hormonal Therapy	81	732
other	Constipation/bowel obstruction	Gastrointestinal disorders	Intermittent Hormonal Therapy	55	702
other	Diarrhea without colostomy	Gastrointestinal disorders	Continuous Hormonal Therapy	93	732
other	Diarrhea without colostomy	Gastrointestinal disorders	Intermittent Hormonal Therapy	79	702
other	Nausea	Gastrointestinal disorders	Continuous Hormonal Therapy	54	732
other	Nausea	Gastrointestinal disorders	Intermittent Hormonal Therapy	38	702
other	Fatigue/malaise/lethargy	General disorders	Continuous Hormonal Therapy	381	732
other	Fatigue/malaise/lethargy	General disorders	Intermittent Hormonal Therapy	364	702

1 to 10 of 80Source ClinicalTrials.gov

See all 80 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Continuous Hormonal Therapy
Total, all-cause mortality	Intermittent Hormonal Therapy
Total, other adverse events	Continuous Hormonal Therapy	665	732
Total, other adverse events	Intermittent Hormonal Therapy	609	702
Total, serious adverse events	Continuous Hormonal Therapy	19	732
Total, serious adverse events	Intermittent Hormonal Therapy	10	702

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
16921051	RESULT	PubMed
19380444	BACKGROUND	PubMed
22921015	BACKGROUND	PubMed
23550669	DERIVED	PubMed
25087673	DERIVED	PubMed
26720308	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons1

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

Comparison
Continuous Hormonal Therapy vs Intermittent Hormonal Therapy: serious adverse events

Source 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.

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