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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 9, 2004
Last Update Posted: June 24, 2013
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.
Information provided by:
National Cancer Institute (NCI)

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 tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well neoadjuvant exisulind works in treating patients who are undergoing radical prostatectomy for stage II or stage III prostate cancer.

Condition Intervention Phase
Prostate Cancer Drug: exisulind Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: A Prospective Phase II Study of Preoperative, Controlled Exisulind Therapy Initiated Prior to Radical Prostatectomy: Effect on Apoptosis

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Apoptosis 4 weeks after completion of study as assessed by marker analysis (bcl-2, Bax, Par-4, M30, TUNEL assay, PTEN)

Secondary Outcome Measures:
  • Modulation of other surrogate endpoint biomarkers (prostate-specific antigen high-grade prostatic intraepithelial neoplasia, MIB-1, and DNA ploidy)

Estimated Enrollment: 130
Study Start Date: August 2003
Study Completion Date: September 2006
Detailed Description:



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


  • Determine the effect of this drug (preoperatively) on surrogate endpoint biomarkers (i.e., prostate-specific antigen, high-grade prostatic intraepithelial neoplasia, MIB-1, and DNA ploidy) in these patients.

OUTLINE: This is a nonrandomized, controlled study. Patients are assigned to 1 of 2 groups based on the treating physician.

  • Control group: Patients undergo radical prostatectomy only.
  • Treatment group: Patients receive oral exisulind once daily for 4 weeks. Patients then undergo radical prostatectomy.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 130 patients (65 per group) will be accrued for this study within approximately 10-12 months.


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • 40 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • Not specified


  • 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


  • Creatinine < 1.5 mg/dL


  • Fertile patients must use effective contraception
  • No hypersensitivity to sulindac (treatment group)


Biologic therapy

  • No concurrent immunotherapy


  • 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


  • No prior pelvic radiotherapy
  • No concurrent radiotherapy


  • See Disease Characteristics


  • 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
  Contacts and Locations
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): NCT00078910

United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Bradley C. Leibovich, MD Mayo Clinic
  More Information

ClinicalTrials.gov Identifier: NCT00078910     History of Changes
Other Study ID Numbers: CDR0000353196
First Submitted: March 8, 2004
First Posted: March 9, 2004
Last Update Posted: June 24, 2013
Last Verified: September 2006

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Sulindac sulfone
Antineoplastic Agents
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents