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Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00860158
Recruitment Status : Terminated (Slow accrual; closed by funder)
First Posted : March 12, 2009
Results First Posted : February 5, 2016
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Noah Hahn, M.D., Hoosier Cancer Research Network

Brief Summary:
This trial will investigate the activity of dasatinib plus LHRH analogue therapy in high-risk localized prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Dasatinib Drug: Leuprolide Acetate (LHRH Analogue) Procedure: Radical Prostatectomy Phase 2

Detailed Description:

OUTLINE: This is a multi-center study.

  • Dasatinib -100 mg administered once daily per oral route for 28 consecutive days.
  • Leuprolide acetate - 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).

The 28 days of dasatinib and leuprolide injection (plus the time required to recover from toxicity if encountered) is defined as a cycle. Patients will be treated for up to a maximum of 3 cycles of dasatinib and leuprolide acetate.

Radical Prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Hematopoietic:

  • Hemoglobin (Hgb) ≥ 8.0 g/dL
  • Platelets ≥ 100 K/mm3
  • Absolute neutrophil count (ANC) ≥ 1.0 K/mm3

Hepatic:

  • Total bilirubin < 2.0 X Upper Limit Normal (ULN)
  • Aspartate aminotransferase (AST) < 2.5 X ULN
  • Alanine aminotransferase (ALT) < 2.5 X ULN

Renal:

  • Calculated creatinine clearance of ≥ 60 cc/min using the Cockcroft-Gault formula

Cardiovascular:

  • No uncontrolled angina, congestive heart failure or myocardial infarction within 6 months prior to registration for protocol therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer
Study Start Date : March 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Single Arm Assignment
Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy
Drug: Dasatinib
Dasatinib 100 mg administered once daily per oral route for 28 consecutive days

Drug: Leuprolide Acetate (LHRH Analogue)
Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).

Procedure: Radical Prostatectomy
Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.




Primary Outcome Measures :
  1. To Estimate the Pathologic Complete Response (pCR) Rate [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. To Estimate Partial Pathologic Responses (pPR) [ Time Frame: 18 months ]
  2. To Estimate PSA Response Rate [ Time Frame: 18 months ]
  3. To Estimate Progression Free Survival [ Time Frame: 18 months ]
  4. To Evaluate the Impact of Dasatinib Plus LHRH on Expression of Selected Biomarkers [ Time Frame: 18 months ]
  5. To Estimate Safety and Tolerability of LHRH Plus Dasatinib [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate.
  • Clinical stage T1-T3a disease.
  • Must be willing to have a tumor biopsy, if previous tumor tissue unavailable for tumor marker analysis.
  • Kattan pre-operative nomogram-predicted (based on stage, Prostate Specific Antigen (PSA) and Gleason score) 5-year risk of recurrence-free survival of 80% or less
  • Must be deemed eligible for radical prostatectomy.
  • Must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
  • Written informed consent and HIPAA authorization for release of personal health information.
  • Age > 18 years at the time of consent.

Exclusion Criteria:

  • No evidence of regional, lymph node or distant metastasis on clinical or radiological assessments. All baseline radiology studies must be performed within 28 days prior to registration for protocol therapy.
  • No prior malignancy in the past 2 years except for basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), and colonic polyp with focus of adenocarcinoma) can be enrolled after approval from the Sponsor Investigator.
  • No prior hormonal therapy with the exception of oral 5-alpha-reductase inhibitors (finasteride, dutasteride, etc.). Patients who have received prior oral anti-androgen therapies (bicalutamide, flutamide, nilutamide, etc.), prior LHRH agonist therapy (leuprolide, goserelin acetate, etc.), or prior orchiectomy are ineligible.
  • No prior systemic chemotherapy or radiotherapy for prostate cancer is allowed. Transurethral resection of the prostate for benign prostatic hypertrophy (BPH) and oral alpha-blockers (terazosin, tamsulosin, doxazosin) are permitted.
  • No history of hemorrhage or thrombotic events (cerebrovascular accident, deep vein thrombosis, pulmonary embolism, etc.) within 6 months prior to registration for protocol therapy.
  • No history of diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
  • No history of diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) of registration on protocol therapy.
  • No history of ongoing or recent (≤ 3 months of registration on protocol therapy) significant gastrointestinal bleeding
  • No ongoing anti-coagulation and/or anti-platelet therapies allowed.
  • No unresolved pleural or pericardial effusion of any grade within 3 months of registration for protocol therapy.
  • No uncontrolled angina, congestive heart failure or MI within 6 months prior to registration for protocol therapy.
  • No diagnosed congenital long QT syndrome.
  • No history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes).
  • No prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)
  • Following medications must be discontinued at least 7 days prior to registration for protocol therapy and be withheld for the duration of dasatinib therapy:
  • Drugs that are generally accepted to have a risk of causing Torsades de Pointes
  • Patient must not be receiving any prohibited CYP3A4 inhibitors /inducers/ substrates
  • Anti-coagulation and/or anti-platelet therapies - to avoid potential bleeding risks.
  • No major surgical procedure, open biopsy, or significant trauma within 28 days prior to registration for protocol therapy.
  • Ability to comply with study and/or follow-up procedures and requirements.
  • No treatment with any investigational agent for any medical condition within 28 days prior to registration for protocol therapy.
  • No clinically significant infections or any other condition which, in the investigator's opinion, deems the patient an unsuitable candidate to receive the study drug.
  • Ability to take oral medication (dasatinib must be swallowed whole).
  • No known history of hypokalemia that cannot be corrected prior to registration on protocol therapy.
  • No known history of hypomagnesemia that cannot be corrected prior to registration on protocol therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860158


Locations
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United States, Arizona
Mayo Clinic Hospital
Scottsdale, Arizona, United States, 85054
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Noah Hahn, M.D.
Bristol-Myers Squibb
Investigators
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Study Chair: Noah Hahn, M.D. Hoosier Cancer Research Network

Additional Information:
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Responsible Party: Noah Hahn, M.D., Sponsor-Investigator, Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT00860158     History of Changes
Other Study ID Numbers: HOG GU07-124
First Posted: March 12, 2009    Key Record Dates
Results First Posted: February 5, 2016
Last Update Posted: March 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dasatinib
Leuprolide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal