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

NCT00860158 | Terminated Phase 2 Results DMC

• 1 other identifier: HOG GU07-124
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To Estimate the Pathologic Complete Response (pCR) Rate

  18 months

Secondary Outcomes (5)

• To Estimate Partial Pathologic Responses (pPR)

  18 months

• To Estimate PSA Response Rate

  18 months

• To Estimate Progression Free Survival

  18 months

• To Evaluate the Impact of Dasatinib Plus LHRH on Expression of Selected Biomarkers

  18 months

• To Estimate Safety and Tolerability of LHRH Plus Dasatinib

  18 months

Study Arms (1)

Single Arm Assignment

EXPERIMENTAL

Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy

Drug: Dasatinib; Drug: Leuprolide Acetate (LHRH Analogue); Procedure: Radical Prostatectomy

Interventions

Dasatinib DRUG

Dasatinib 100 mg administered once daily per oral route for 28 consecutive days

Single Arm Assignment

Leuprolide Acetate (LHRH Analogue) DRUG

Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).

Single Arm Assignment

Radical Prostatectomy PROCEDURE

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

Single Arm Assignment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Noah Hahn, M.D.: lead
• Bristol-Myers Squibb: collaborator

Study Sites (6)

Mayo Clinic Hospital

Scottsdale, Arizona, 85054, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Medical & Surgical Specialists, LLC

Galesburg, Illinois, 61401, United States

Location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Related Links

• Hoosier Oncology Group Homepage

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dasatinib; Leuprolide; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Limitations and Caveats

This study was terminated due to slow accrual and no results were analyzed.

Results Point of Contact

• Title: Principal Investigator
• Organization: Hoosier Cancer Research Network, Inc.

jsmith@hoosiercancer.org

317-921-2050

Study Officials

• Noah Hahn, M.D.

  Hoosier Cancer Research Network

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 12, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 14, 2018
• Results First Posted: February 5, 2016

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)