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OpenTrials
Completed

NCT Number: NCT00166426

Exisulind Versus Placebo After Surgical Removal of the Prostate

This is a study in which patients with prostate cancer treated by surgical removal of the prostate and considered to be at risk for prostate cancer recurrence will receive Exisulind 250 mg twice a day or placebo twice a day for two years.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Males 18 years of age or older with prostate cancer treated primarily by radical prostatectomy and randomized within 45 days after surgery may be eligible for enrollment into this protocol. Participants cannot have had hormonal therapy, cryotherapy, thermotherapy, or radiotherapy prior to entering the study.

Treatment and study plan

Exisulind

Drug

Primary outcomes

  1. Assess efficacy of drug vs placebo regarding overall rate of biochemical progression

  2. Assess the efficacy of drug vs placebo regarding time to biochemical progression

  3. Assess efficacy of drug vs placebo regarding overall rate of clinical progression

  4. Assess efficacy of drug vs placebo regarding time to clinical progression

  5. Assess efficacy of drug vs placebo regarding cancer specific survival

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • OSI Pharmaceuticals

Registry information

Official study title

Prospective, Randomized, Double-Blind Trial of Adjuvant Exisulind Versus Placebo for Patients at Risk for Prostate Cancer Recurrence After Radical Prostatectomy

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
Sep 14, 2005
Registry last updated
Nov 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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