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Status:

COMPLETED

Neoadjuvant Exisulind in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage II or Stage III Prostate Cancer

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Prostate Cancer

Eligibility:

MALE

40+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as exisulind, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the...

Detailed Description

OBJECTIVES: Primary * Compare the effect of neoadjuvant exisulind vs no neoadjuvant treatment on apoptosis in patients with stage II or III prostate cancer undergoing radical prostatectomy. Seconda...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed adenocarcinoma of the prostate
  • Clinical stage T1c-3b, N0-X, M0
  • Gleason score ≥ 6
  • Planning to undergo pelvic lymphadenectomy and radical prostatectomy at Mayo Clinic Rochester
  • Interval from biopsy to prostatectomy is at least 4, but no more than 14, weeks
  • Selected patients of Dr. R. P. Myers who are undergoing prostatectomy during the enrollment period will be assigned to the control group\* NOTE: \*Additional historical controls may be selected from Dr. Myers' patients who underwent prostatectomy within the past 4 years
  • PATIENT CHARACTERISTICS:
  • Age
  • 40 and over
  • Performance status
  • ECOG 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Not specified
  • Hepatic
  • ALT normal (10-45 U/L)
  • AST normal (12-31 U/L)
  • Alkaline phosphatase normal (119-309 U/L)
  • Bilirubin normal (0.1-1.0 mg/dL)
  • No history of hepatitis, cirrhosis, or other hepatic dysfunction
  • Renal
  • Creatinine \< 1.5 mg/dL
  • Other
  • Fertile patients must use effective contraception
  • No hypersensitivity to sulindac (treatment group)
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No concurrent immunotherapy
  • Chemotherapy
  • No other concurrent chemotherapy
  • Endocrine therapy
  • No prior ablation (treatment group)
  • No prior hormone replacement or antiandrogen therapy (e.g., testosterone, diethylstilbestrol, leuprolide, goserelin, flutamide, bicalutamide, finasteride, nilutamide, or megestrol)
  • No concurrent antiandrogen therapy, luteinizing hormone-releasing hormone agonists, finasteride, or diethylstilbestrol
  • Radiotherapy
  • No prior pelvic radiotherapy
  • No concurrent radiotherapy
  • Surgery
  • See Disease Characteristics
  • Other
  • No prior treatment for prostate cancer before prostatectomy (control group)
  • No concurrent cyclooxygenase-2 inhibitors
  • No concurrent sulindac
  • No concurrent nonsteroidal anti-inflammatory drugs except low-dose (no more than 325 mg/day) aspirin for cardiovascular prophylaxis

Exclusion

    Key Trial Info

    Start Date :

    August 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 1 2006

    Estimated Enrollment :

    130 Patients enrolled

    Trial Details

    Trial ID

    NCT00078910

    Start Date

    August 1 2003

    End Date

    September 1 2006

    Last Update

    June 24 2013

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Mayo Clinic Scottsdale

    Scottsdale, Arizona, United States, 85259-5499

    2

    Mayo Clinic - Jacksonville

    Jacksonville, Florida, United States, 32224

    3

    Mayo Clinic Cancer Center

    Rochester, Minnesota, United States, 55905