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Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v44

  2. Notable

    Primary and study completion dates: Dec 31, 2025 to Dec 31, 2027

    Study Statusv43

  3. Minor

    2 amendments

    2 re-verifications since 2025-05-29, no change to tracked fields

    v41-v42

  4. Minor

    Start date: May 2006 to May 15, 2006

    Study Statusv40

  5. Minor

    Study Status

    Re-verified, no change to tracked fields

    v39

Show 37 earlier versions

  1. Notable

    Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025

    Study Statusv38

  2. Minor

    Study Status

    Re-verified, no change to tracked fields

    v37

  3. Notable

    Primary and study completion dates: Dec 31, 2023 to Dec 31, 2024

    Study Statusv36

  4. Minor

    2 amendments

    2 re-verifications since 2023-06-01, no change to tracked fields

    v34-v35

  5. Notable

    Primary and study completion dates: Dec 31, 2022 to Dec 31, 2023

    Study Statusv33

  6. Minor

    Primary and study completion dates: Dec 1, 2022 to Dec 31, 2022

    Study Statusv32

  7. Minor

    Study Status

    Re-verified, no change to tracked fields

    v31

  8. Notable

    Primary completion date: Dec 1, 2021 to Dec 1, 2022

    Study Statusv30

  9. Notable

    Primary completion date: Dec 1, 2020 to Dec 1, 2021

    Completion date: Dec 1, 2021 to Dec 1, 2022

    Study Statusv29

  10. Notable

    Primary completion date: Dec 31, 2019 to Dec 1, 2020

    Completion date: Dec 31, 2019 to Dec 1, 2021

    Study Statusv28

  11. Minor

    Study Status

    Re-verified, no change to tracked fields

    v27

  12. Notable

    Primary and study completion dates: May 2019 to Dec 31, 2019

    Study Statusv26

  13. Minor

    4 amendments

    4 re-verifications since 2017-09-29, no change to tracked fields

    v22-v25

  14. Minor

    Primary completion date: Dec 2018 to May 2019

    Completion date: May 2019

    Study Status, Oversightv21

  15. Notable

    Primary completion date: Dec 2017 to Dec 2018

    Study Statusv20

  16. Notable

    Primary completion date: Dec 2015 to Dec 2017

    Completion date: Dec 2015 to not stated

    Study Statusv19

  17. Notable

    Primary and study completion dates: Dec 2014 to Dec 2015

    Study site revised

    Show what changed: Study sites
    UTUniversity of Texas MD Anderson Cancer Center

    Study Identification, Study Status, Outcome Measures, Contacts/Locations, Referencesv18

  18. Minor

    Study Status

    Re-verified, no change to tracked fields

    v17

  19. Notable

    Primary and study completion dates: Dec 2012 to Dec 2014

    Study Status, Study Design, Arms and Interventionsv16

  20. Minor

    Study Status, Sponsor/Collaborators

    Re-verified, no change to tracked fields

    v15

  21. Notable

    Primary completion date: Dec 2011 to Dec 2012

    Study Statusv14

  22. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised

    Study Status, Contacts/Locationsv13

  23. Minor

    Study site revised

    Show what changed: Study sites
    U.T.M.D.UT MD Anderson Cancer Center

    Study Status, Contacts/Locationsv12

  24. Notable

    Enrollment target: 42 to 64

    Study Status, Study Designv11

  25. Minor

    Eligibility criteria shortened, about 11 words

    Study description expanded, about 34 words

    Show what changed: Eligibility criteria
    [...] mm^3 and platelet count of >= 100,000/mm^3; hemoglobin >= 9.0 g0g/dl; adequate hepatic function defined as a total bilirubin [...] 1.5 x the upper limits of normal or creatinine clearance >= 40 cc40cc/min (measured or calculated). Patients must sign the curren [...] apeutic doses of coumadin. However, low dose coumadin up to 2 mg2mg PO daily for deep vein thrombosis prophylaxis is allowed. L [...]
    Show what changed: Study description
    [...] ly activities (performance status evaluation.) On Day 15 of eachCycle cycle1, you will be asked about any side effects you have experien [...] fter surgery you will begin having PSA tests every 6 months. This is an investigational study. Sunitinib malate has been authorized by the FDA for research purposes only. About 64 patients will take part in this study. All will be enrolled at M. D. Anderson.

    Study Status, Study Description, Arms and Interventions, Eligibilityv10

  26. Minor

    Study Status

    Re-verified, no change to tracked fields

    v9

  27. Notable

    Trial status: Active, Not Recruiting to Recruiting

    Primary completion date: Dec 2008 to Dec 2011; Primary endpoint revised; Completion date: Dec 2012; and 2 more

    Show all 6 changes in this update
    • Notable Trial status: Active, Not Recruiting to Recruiting
    • Notable Primary completion date: Dec 2008 to Dec 2011
    • Notable Primary endpoint revised
      Show what changed
      To learn if the additionNumber of sunitinibParticipants malateWith Pathological Complete Response (SU011248pCR) to hormone-based castration is an effective treatment for shrinking or controlling the tumor before having the prostate removed
    • Minor Completion date: Dec 2012
    • Minor Study description shortened, about 34 words
      Show what changed
      [...] est that measures the electrical activity of the heart) and and an echocardiogram. An echocardiogram uses sound waves to mak [...] y to perform daily activities (performance status evaluation.). On Day 15 of each cycle, you will be asked about any side e [...] ncing and you will have a physical exam. You will also have a digital rectal exam. Blood (about 2 teaspoons) will be drawn [...] ostate specific antigen (PSA) blood test every 3 months. Two (2) years after surgery you will begin having PSA tests every 6 months. This is an investigational study. Sunitinib malate has been authorized by the FDA for research pur [...]
    • Minor Site details revised

    Study Status, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locationsv8

  28. Notable

    Primary completion date: May 2008 to Dec 2008

    Study Status, Referencesv7

  29. Minor

    Eligibility criteria expanded, about 11 words

    Primary endpoint revised; Study description shortened, about 1 word

    Show what changed: Eligibility criteria
    [...] mm^3 and platelet count of >= 100,000/mm^3; hemoglobin >= 9.0g0 g/dl; adequate hepatic function defined as a total bilirubin [...] 1.5 x the upper limits of normal or creatinine clearance >= 40cc40 cc/min (measured or calculated). Patients must sign the curren [...] apeutic doses of coumadin. However, low dose coumadin up to 2mg2 mg PO daily for deep vein thrombosis prophylaxis is allowed. L [...]
    Show what changed: Primary endpoints
    To learn if the addition of sunitinib malate (SU011248) to hormone-based castration is an effective treatment for shrinking or controlling the tumor before having the prostate removed.
    Show what changed: Study description
    [...] y to perform daily activities (performance status evaluation).) On Day 15 of each cycle, you will be asked about any side e [...] ncing and you will have a physical exam. You will also have a digital rectal exam. Blood (about 2 teaspoons) will be drawn [...] ostate specific antigen (PSA) blood test every 3 months. Two (2) years after surgery you will begin having PSA tests every 6 [...]

    Study Status, Study Description, Outcome Measures, Eligibilityv6

  30. Notable

    Primary endpoint revised

    Trial status: Recruiting to Active, Not Recruiting; Enrollment target: 36 to 42; Interventions: LHRH agonist (Drug), Radical Prostatectomy (Procedure), Sunitinib Malate (Drug) to LHRH Agonist (Drug), Radical Prostatectomy (Procedure), Sunitinib Malate (Drug); and 3 more

    Show all 7 changes in this update
    • Notable Primary endpoint revised
      Show what changed
      To evaluatelearn if the pathologicaladdition complete response (pCR) rate to neoadjuvant hormonal ablation &of sunitinib malate in(SU011248) high-riskto localizedhormone based castration is an effective treatment for shrinking or controlling the tumor before having the prostate cancerremoved.
    • Minor Trial status: Recruiting to Active, Not Recruiting
    • Minor Enrollment target: 36 to 42
    • Minor Interventions: LHRH agonist (Drug), Radical Prostatectomy (Procedure), Sunitinib Malate (Drug) to LHRH Agonist (Drug), Radical Prostatectomy (Procedure), Sunitinib Malate (Drug)
    • Minor Secondary endpoints shortened, about 53 words
      Show what changed
      To evaluate the time to PSA-progression after neoadjuvant hormonal ablation & sunitinib malate, and Radical Prostatectomy (RP), in high-risk localized prostate cancer. To evaluate the perioperative and postoperative morbidity with RP after neoadjuvant hormonal ablation and SU011248/sunitinib malate. [...]
    • Minor Study description shortened, about 12 words
      Show what changed
      [...] has been authorized by the FDA for research purposes only. The sunitinib malate will be provided free of charge during this study. About 42 patients will take part in this study. All will be enrolled at M. D. Anderson.
    • Minor Site details revised

    Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locationsv5

  31. Notable

    Primary endpoints: 2 to 1

    Primary completion date: May 2008; Interventions: LHRH agonist (Drug), Sunitinib Malate (SU011248) (Drug) to LHRH agonist (Drug), Radical Prostatectomy (Procedure), Sunitinib Malate (Drug); Eligibility criteria expanded, about 169 words; and 4 more

    Show all 8 changes in this update
    • Notable Primary endpoints: 2 to 1
      Show what changed
      To evaluate the time to PSA-progression after neoadjuvant hormonal ablation & sunitinib malate, and Radical Prostatectomy (RP), in high-risk localized prostate
    • Minor Primary completion date: May 2008
    • Minor Interventions: LHRH agonist (Drug), Sunitinib Malate (SU011248) (Drug) to LHRH agonist (Drug), Radical Prostatectomy (Procedure), Sunitinib Malate (Drug)
    • Minor Eligibility criteria expanded, about 169 words
      Show what changed
      [...] 0 or 1. Prior hormonal therapy up to 2 months is permitted.- reasonablePatients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of >= 1, kidney500/mm^3 and platelet count of >= 100,000/mm^3; hemoglobin >= 9.0g/dl; adequate hepatic function defined as a total bilirubin of <=1.5 mg/dl and AST/ALT <= 2 x the upper limit of normal; adequate renal function defined as serum creatinine <= 1.5 x the upper limits of normal or creatinine clearance >= 40cc/min (measured or calculated). Patients must sign the current IRB approved informed consent indicating tha [...] [...]
    • Minor Secondary endpoints expanded, about 53 words
      Show what changed
      To evaluate the time to PSA-progression after neoadjuvant hormonal ablation & sunitinib malate, and Radical Prostatectomy (RP), in high-risk localized prostate cancer. To evaluate the perioperative and postoperative morbidity with RP after neoadjuvant hormonal ablation and SU011248/sunitinib malate. [...]
    • Minor Study description expanded, about 787 words
      Show what changed
      Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer. Hormonal treatment is used to lower testosterone levels in the body because prostate cancer cells need testosterone to survive. Before you can [...]
    • Minor Site contact updated
    • Minor Study arms: 0 to 1

    Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv4

  32. Minor

    Interventions: LHRH agonist (Drug), Sunitinib Malate (Drug) to LHRH agonist (Drug), Sunitinib Malate (SU011248) (Drug)

    Study site revised; Collaborators expanded, about 1 word

    Show what changed: Study sites
    UT MDU.T.M.D. Anderson Cancer Center
    Show what changed: Collaborators
    Pfizer

    Study Status, Sponsor/Collaborators, Oversight, Conditions, Study Design, Arms and Interventions, Contacts/Locationsv3

  33. Minor

    Completion date: May 2006 to not stated

    Interventions: LHRH agonist and sunitinib malate (Drug) to LHRH agonist (Drug), Sunitinib Malate (Drug); Study title expanded, about 6 words

    Show what changed: Study title
    Sunitinib Malate PlusWith Hormonal Ablation for Patients Who Will Have Prostatectomy

    Study Identification, Study Status, Arms and Interventions, Eligibilityv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical research study is to learn if the addition of sunitinib malate (SU011248) to hormone based castration is an effective treatment for shrinking or controlling the tumor before having the prostate removed.
Trial Details
NCT Number NCT00329043
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: Pfizer
Conditions Prostate Cancer
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov