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A Phase II Study of Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase II Study of Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer


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.

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 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 MI within 6 months prior to
registration for protocol therapy.


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, 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the pathologic complete response (pCR) rate

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Noah Hahn, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

HOG GU07-124

NCT ID:

NCT00860158

Start Date:

March 2009

Completion Date:

December 2010

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Virginia Oncology AssociatesNewport News, Virginia  23606
Mayo Clinic HospitalPhoenix, Arizona  85054-4502
University of FloridaGainesville, Florida  32610-0277
University of ChicagoChicago, Illinois  60637
Medical & Surgical Specialists, LLCGalesburg, Illinois  61401
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202