Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

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

NCT01809691 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,313 participants
Start Date 2013-03-08
Est. Completion 2025-09-09
Phase Phase 3

Sponsor

SWOG Cancer Research Network

212 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01809691

The ClinicalTrials.gov registry entry for NCT01809691 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,313 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01809691 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01809691?

The interventions under investigation include: Bicalutamide (DRUG), TAK-700 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01809691?

This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial