CClinicalTrials.gg
CompletedNCT00166478Updated Jan 28, 2010

Exisulind Prior to Radical Prostatectomy

A Phase 2 interventional study of Exisulind Therapy in Prostatic Neoplasms, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2010-01-28.

Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
130
Allocation
Non-randomized
Ages
40 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostatic Neoplasms

Browse trials for

03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 130 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility 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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants (actual)

Interventions

  • DrugExisulind Therapy
06

What researchers measure

Primary outcomes

  1. 4 week changes in apoptosis biomarkers

Secondary outcomes

  1. 4 week changes in surrogate endpoint biomarkers

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00166478
Lead sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
First posted
Sep 14, 2005
Start date
Apr 2002
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Jan 28, 2010

Study contacts

Bradley C. Leibovich, M.D.
principal investigator · Mayo Clinic
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion