Clinical trial · Interventional
Neoadjuvant Exisulind in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage II or Stage III Prostate Cancer
A Prospective Phase II Study of Preoperative, Controlled Exisulind Therapy Initiated Prior to Radical Prostatectomy: Effect on Apoptosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| exisulind | Drug | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Apoptosis 4 weeks after completion of study as assessed by marker analysis (bcl-2, Bax, Par-4, M30, TUNEL assay, PTEN)
Secondary outcomes (1)
- measure
- Modulation of other surrogate endpoint biomarkers (prostate-specific antigen high-grade prostatic intraepithelial neoplasia, MIB-1, and DNA ploidy)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available