deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01809691

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

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer

Sponsor: Millennium Pharmaceuticals, Inc.

Conditions Prostate Cancer
Interventions Bicalutamide TAK-700
Updated 23 times since 2017 Last updated: Dec 10, 2025 Started: Mar 8, 2013 Primary completion: Mar 8, 2022 Completion: Sep 9, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Prostate Cancer, this trial is completed. The trial is conducted by Millennium Pharmaceuticals, Inc. and has accumulated 23 data snapshots since 2013. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~Jun 2017 · 3 months · monthly snapshot~Jun 2017 – ~Sep 2017 · 3 months · monthly snapshot~Sep 2017 – ~Jun 2018 · 9 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Jul 2019 · 10 months · monthly snapshot~Jul 2019 – ~Jul 2020 · 12 months · monthly snapshot~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Sep 2022 · 12 months · monthly snapshot~Sep 2022 – ~Jan 2023 · 4 months · monthly snapshot~Jan 2023 – ~May 2023 · 4 months · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Dec 2023 · 6 months · monthly snapshot~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Apr 2025 · 3 months · monthly snapshot~Apr 2025 – ~Sep 2025 · 5 months · monthly snapshot~Sep 2025 – ~Jan 2026 · 4 months · monthly snapshot~Jan 2026 – present · 7 months · monthly snapshot

Change History

23 versions recorded

  1. Jan 2026 — Present [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  2. Sep 2025 — Jan 2026 [monthly]

    Active Not Recruiting PHASE3

  3. Apr 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Jan 2025 — Apr 2025 [monthly]

    Active Not Recruiting PHASE3

  5. Dec 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE3

▶ Show 18 earlier versions

  1. Sep 2024 — Dec 2024 [monthly]

    Active Not Recruiting PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  3. Dec 2023 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

  4. Jun 2023 — Dec 2023 [monthly]

    Active Not Recruiting PHASE3

  5. May 2023 — Jun 2023 [monthly]

    Active Not Recruiting PHASE3

  6. Jan 2023 — May 2023 [monthly]

    Active Not Recruiting PHASE3

  7. Sep 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE3

  8. Sep 2021 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  9. Jan 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE3

  10. Jul 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  11. Jul 2019 — Jul 2020 [monthly]

    Active Not Recruiting PHASE3

  12. Sep 2018 — Jul 2019 [monthly]

    Active Not Recruiting PHASE3

  13. Jun 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE3

  14. Sep 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  15. Jun 2017 — Sep 2017 [monthly]

    Recruiting PHASE3

  16. Mar 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  17. Feb 2017 — Mar 2017 [monthly]

    Recruiting PHASE3

  18. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Mar 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Millennium Pharmaceuticals, Inc.
  • National Cancer Institute (NCI)
  • SWOG Cancer Research Network
Data source: SWOG Cancer Research Network

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Adrian, United States , Akron, United States , Albuquerque, United States , Allentown, United States , Ames, United States , Anderson, United States , Ann Arbor, United States , Antigo, United States , Antioch, United States , Asheville, United States and 350 more locations