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


Phase 2
40 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Bradley C. Leibovich, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000353196

NCT ID:

NCT00078910

Start Date:

August 2003

Completion Date:

September 2006

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905