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

Prostate Cancer Clinical Trial

Official title:

A Prospective Phase II Study of Preoperative, Controlled Exisulind Therapy Initiated Prior to Radical Prostatectomy: Effect on Apoptosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00078910
• Other study ID #: CDR0000353196
• Secondary ID: MAYO-229701
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2004
• Last updated: June 21, 2013
• Start date: August 2003
• Est. completion date: September 2006

Study information

• Verified date: September 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• exisulind

Procedure:
• conventional surgery

• neoadjuvant therapy

Locations

Country	Name	City	State
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apoptosis 4 weeks after completion of study as assessed by marker analysis (bcl-2, Bax, Par-4, M30, TUNEL assay, PTEN)			No
Secondary	Modulation of other surrogate endpoint biomarkers (prostate-specific antigen high-grade prostatic intraepithelial neoplasia, MIB-1, and DNA ploidy)			No