Exisulind Prior to Radical Prostatectomy

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00166478

Enrollment

130

Registered

2005-09-14

Start date

2002-04-30

Completion date

2007-10-31

Last updated

2010-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

Brief summary

This trial will compare no treatment to exisulind therapy. Patients enrolled on the treatment arm will begin treatment 4 weeks prior to the scheduled date of surgical removal of the prostate and will take 375 mg by mouth daily for the 4 weeks prior to radical prostatectomy. Participants will be followed for total of 2 months from the time of starting study drug.

Interventions

DRUGExisulind Therapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

Males 40 years of age and older with prostate cancer who are scheduled to undergo surgical removal of the prostate at Mayo Clinic Rochester, Mayo Clinic Jacksonville, or Mayo Clinic Arizona may be eligible for this protocol.

Design outcomes

Primary

Measure	Time frame
4 week changes in apoptosis biomarkers	—

Secondary

Measure	Time frame
4 week changes in surrogate endpoint biomarkers	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026