Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

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

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.

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.
  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: 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

Relevance to patient case: not relevant