deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT00901342

Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer

An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer

Sponsor: Dendreon

Conditions Prostate Cancer
Interventions sipuleucel-T
Updated 9 times since 2017 Last updated: Apr 21, 2017 Started: Oct 31, 2009 Primary completion: Dec 31, 2014 Completion: Jun 30, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Prostate Cancer, this trial is completed. The trial is conducted by Dendreon and has accumulated 9 data snapshots since 2009. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

Subjects received sipuleucel-T at 2-week intervals, for a total of 3 infusions. The study evaluated the safety and magnitude of the immune responses to treatment with sipuleucel-T. All subjects were followed for 30 days following the last infusion of sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse event (SAE)s and cerebrovascular event (CVE)s were collected via Long Term Follow-up Telephone Assessment occurring Q6 months.

Subjects received sipuleucel-T at 2-week intervals, for a total of 3 infusions. The study evaluated the safety and magnitude of the immune responses to treatment with sipuleucel-T. All subjects were followed for 30 days following the last infusion of sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse event (SAE)s and cerebrovascular event (CVE)s were collected via Long Term Follow-up Telephone Assessment occurring Q6 months.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~May 2017 · 3 months · monthly snapshotCompleted~May 2017 – ~Jul 2017 · 2 months · monthly snapshotCompleted~Jul 2017 – ~Jun 2018 · 11 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

9 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

▶ Show 4 earlier versions

  1. Jul 2017 — Jun 2018 [monthly]

    Completed PHASE2

  2. May 2017 — Jul 2017 [monthly]

    Completed PHASE2

  3. Feb 2017 — May 2017 [monthly]

    Completed PHASE2

  4. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Oct 2009

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Dendreon
Data source: Dendreon

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

Study Locations

Chicago, United States , Cincinnati, United States , Dallas, United States , Durham, United States , Greenbelt, United States , Hackensack, United States , Indianapolis, United States , Nashville, United States , New York, United States , Park Ridge, United States and 5 more locations