Trial · NCT01809691

S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer

NCT01809691, Phase 3, Completed, SWOG Cancer Research Network; results first posted 2022-09-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer. Trials, record NCT01809691. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01809691

On this page

Trial

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

Title: S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer
NCT number: NCT01809691
Status: Completed
Phases: Phase 3
Enrollment: 1,313 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Prostate Cancer
Interventions: TAK-700, Bicalutamide
First posted: 2013-03-13
Last updated: 2025-12-31
Results first posted: 2022-09-08

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	Duration of treatment and follow-up until death or 9 years after study start	Overall survival is defined as the time from random assignment to the date of death from any cause
Secondary	Progression Free Survival	Duration of treatment and follow-up until death or 9 years after study start	Progression Free Survival (PFS) is defined as the time from random assignment to first documentation of PSA progression, radiologic progression, clinical progression, or death, whichever occurred first. PSA progression is defined as a ≥25% increase AND and absolute increase of at last 2 ng/mL from the nadir PSA (or from baseline PSA if there was no drop in PSA after starting treatment). Radiologic progression is defined as two or more new lesions on radionuclide bone scans. Clinical progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Secondary	PSA Response Rates	7 months after randomization	Prostate-specific antigen (PSA) response rates were divided into complete response (CR: PSA \< 0.2 ng/mL), partial response (PR: PSA between 0.2 and 4.0 ng/mL), and no response (NR: PSA \> 4.0 ng/mL) at a 7-month landmark after random assignment.
Secondary	Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Duration of treatment and follow-up until death or 9 years after study start	Only adverse events that are possibly, probably or definitely related to study drug are reported. Adverse events are graded using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) where grade refers to the severity of the AE. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Secondary	Long-term Survival	After 10 years of follow-up	Long-term survival is defined as the time from random assignment to the date of death from any cause

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	Duration of treatment and follow-up until death or 9 years after study start		months	MEDIAN
SECONDARY	Progression Free Survival	Duration of treatment and follow-up until death or 9 years after study start		months	MEDIAN
SECONDARY	PSA Response Rates	7 months after randomization		percentage of participants	NUMBER
SECONDARY	Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Duration of treatment and follow-up until death or 9 years after study start	Eligible participants who received at least one dose of protocol treatment	Participants	NUMBER
SECONDARY	Long-term Survival	After 10 years of follow-up

Source ClinicalTrials.gov

Results by group240

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

Outcome	Group	Category	Value	Spread	Units
Overall Survival	LHRHa + TAK-700		81.1	95% Confidence Interval 68.0 to NA	months
Overall Survival	LHRHa + Bicalutamide		70.2	95% Confidence Interval 64.6 to 79.5	months
Progression Free Survival	LHRHa + TAK-700		47.6	95% Confidence Interval 42.2 to 54.2	months
Progression Free Survival	LHRHa + Bicalutamide		23.0	95% Confidence Interval 19.3 to 26.3	months
PSA Response Rates	LHRHa + TAK-700	Complete Response	58		percentage of participants
PSA Response Rates	LHRHa + Bicalutamide	Complete Response	44		percentage of participants
PSA Response Rates	LHRHa + TAK-700	Partial Response	22		percentage of participants
PSA Response Rates	LHRHa + Bicalutamide	Partial Response	31		percentage of participants
PSA Response Rates	LHRHa + TAK-700	No Response	19		percentage of participants
PSA Response Rates	LHRHa + Bicalutamide	No Response	25		percentage of participants

1 to 10 of 240Source ClinicalTrials.gov

See all 240 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	LHRHa + TAK-700	638
Overall Study	STARTED	LHRHa + Bicalutamide	641
Overall Study	COMPLETED	LHRHa + TAK-700	0
Overall Study	COMPLETED	LHRHa + Bicalutamide	0
Overall Study	NOT COMPLETED	LHRHa + TAK-700	638
Overall Study	NOT COMPLETED	LHRHa + Bicalutamide	641

Source ClinicalTrials.gov

Adverse events534

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	LHRHa + TAK-700	340	627
other	Anemia	Blood and lymphatic system disorders	LHRHa + Bicalutamide	271	629
other	Sinus tachycardia	Cardiac disorders	LHRHa + TAK-700	36	627
other	Sinus tachycardia	Cardiac disorders	LHRHa + Bicalutamide	15	629
other	Abdominal pain	Gastrointestinal disorders	LHRHa + TAK-700	88	627
other	Abdominal pain	Gastrointestinal disorders	LHRHa + Bicalutamide	50	629
other	Constipation	Gastrointestinal disorders	LHRHa + TAK-700	228	627
other	Constipation	Gastrointestinal disorders	LHRHa + Bicalutamide	133	629
other	Diarrhea	Gastrointestinal disorders	LHRHa + TAK-700	181	627
other	Diarrhea	Gastrointestinal disorders	LHRHa + Bicalutamide	90	629

1 to 10 of 534Source ClinicalTrials.gov

See all 534 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LHRHa + TAK-700	251	638
Total, all-cause mortality	LHRHa + Bicalutamide	274	641
Total, other adverse events	LHRHa + TAK-700	615	627
Total, other adverse events	LHRHa + Bicalutamide	609	629
Total, serious adverse events	LHRHa + TAK-700	235	627
Total, serious adverse events	LHRHa + Bicalutamide	15	629

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35446628	DERIVED	PubMed
37526936	DERIVED	PubMed
38424319	DERIVED	PubMed
38980676	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 comparisons2

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

Comparison	Source
LHRHa + TAK-700 vs LHRHa + Bicalutamide: deaths from any cause	Trial comparisons
LHRHa + TAK-700 vs LHRHa + Bicalutamide: 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/NCT01809691

GET https://conductscience.org/api/trials/v1/NCT01809691/results?page=2

API reference For AI assistants