Neoadjuvant Exisulind in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage II or Stage III Prostate Cancer
This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00078910
First received: March 8, 2004
Last updated: November 9, 2012
Last verified: September 2006
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Purpose
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) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Modulation of other surrogate endpoint biomarkers (prostate-specific antigen high-grade prostatic intraepithelial neoplasia, MIB-1, and DNA ploidy) [ Designated as safety issue: No ]
| Estimated Enrollment: | 130 |
| Study Start Date: | August 2003 |
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.
Secondary
- 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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00078910
Locations
| 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
Investigators
| Principal Investigator: | Bradley C. Leibovich, MD | Mayo Clinic |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00078910 History of Changes |
| Other Study ID Numbers: | CDR0000353196, MAYO-229701 |
| Study First Received: | March 8, 2004 |
| Last Updated: | November 9, 2012 |
| Health Authority: | United States: Federal Government |
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 Neoplasms Genital Diseases, Male Prostatic Diseases Sulindac sulfone Antineoplastic Agents Therapeutic Uses Pharmacologic Actions 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 Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 21, 2013