Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01809691 · ClinicalTrials.gov registry record · Phase 3
S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer
A Phase 3 study of Prostate Cancer, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,313
- Enrollment target
- 20
- Study locations
NCT01809691: Completed Phase 3 study of Prostate Cancer, sponsored by SWOG Cancer Research Network.
NCT01809691 is a Phase 3 study of Prostate Cancer that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 1,313 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (116% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01809691, a Phase 3 study of Prostate Cancer, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,313 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.
Primary Outcome
Overall survival is defined as the time from random assignment to the date of death from any cause
Conditions Studied
Interventions
- DRUG Bicalutamide
- DRUG TAK-700
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Sutter Auburn Faith Hospital - Auburn
- AIS Cancer Center at San Joaquin Community Hospital - Bakersfield
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Mills - Peninsula Hospitals - Burlingame
- City of Hope Corona - Corona
- Sutter Davis Hospital - Davis
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente-Fremont - Fremont
- University Oncology Associates - Fresno
- Kaiser Permanente - Fresno
- UC San Diego Moores Cancer Center - La Jolla
Arizona
- University of Arizona Cancer Center at Saint Joseph's - Phoenix
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
- Southern Arizona Veterans Affairs Health Center - Tucson
- The University of Arizona Medical Center-University Campus - Tucson
Arkansas
- Fowler Family Center for Cancer Care - Jonesboro
- Veteran's Administration Medical Center - Little Rock
Alabama
- Veterans Administration Medical Center - Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,313 participants |
| Start Date | 2013-03-08 |
| Est. Completion | 2025-09-09 |
| Phase | Phase 3 |
What the finished NCT01809691 record still lists
NCT01809691 is an interventional study that assigns participants to a tested intervention. Its 1,313 participants enrollment target places it among the larger protocols in the corpus, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (116% higher).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Bicalutamide is the first listed.
NCT01809691 names 20 study sites across 4 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT01809691 about?
NCT01809691 is a clinical study titled "S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer". The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.
What is the current status of trial NCT01809691?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,313 participants. The study started on 2013-03-08. Estimated completion is 2025-09-09.
What conditions does trial NCT01809691 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT01809691?
The interventions under investigation include: Bicalutamide (DRUG), TAK-700 (DRUG).
Who is sponsoring clinical trial NCT01809691?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01809691 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01809691's enrollment target sits among peer trials
1,313 40th of 735 higher than 696 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
RECRUITING · Phase 3
-
PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.
RECRUITING · Phase 3
-
Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment
RECRUITING · Phase 3
-
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
RECRUITING · Phase 3
-
SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)
RECRUITING · Phase 3
-
Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05176483 · 1,314 participants · Phase 1
Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors
- NCT06136650 · 1,314 participants · Phase 3
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
- NCT06556433 · 1,312 participants · NA
Family-Based Financial Incentives Intervention for Smoking Cessation
- NCT05762302 · 1,316 participants · NA
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI