NCT00078910

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Aug 2003

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2004

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

June 24, 2013

Status Verified

September 1, 2006

First QC Date

March 8, 2004

Last Update Submit

June 21, 2013

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage IIB prostate cancerstage IIA prostate cancerstage III prostate cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Modulation of other surrogate endpoint biomarkers (prostate-specific antigen high-grade prostatic intraepithelial neoplasia, MIB-1, and DNA ploidy)

Interventions

exisulindDRUG
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sulindac sulfoneNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • Bradley C. Leibovich, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

March 8, 2004

First Posted

March 9, 2004

Study Start

August 1, 2003

Study Completion

September 1, 2006

Last Updated

June 24, 2013

Record last verified: 2006-09

Locations

US(3)