Evaluation of the Effect of Exisulind on the Duration of the "Off-Treatment" Interval on Patients With Biochemical Relapse of Prostate Cancer Who Are Treated With Intermittent Androgen Suppression
A study doctor will meet with you and ask you about your medical history, examine you, and
explain the study. We will draw some blood for tests (about 4-6 tablespoons), including
PSA. If not already obtained, you will have a bone scan and a CT scan to establish a
You will be receiving hormone suppression treatment with monthly injections of an LH-RH
analog such as Lupron or Zoladex and an antiandrogen such as Eulexin or Casodex as part of
your standard care for prostate cancer. About 3 months before your next "off-treatment"
period, you will start 1 Exisulind pill 250 mg (2 x 125mg capsules) by mouth twice a day.
It is necessary for you to start the Exisulind treatment 3 months prior to your next
"off-treatment" period so that the medication can build up in your system enough to be
Per our standard follow-up procedures, we will ask you to have blood draws every 2 weeks for
up to 12 weeks after starting Exisulind to check liver function. Thereafter you will be
asked to have monthly blood draws, and return to the clinic every 3 months for a physical
examination, to determine how well you are tolerating the study medication, how your cancer
is responding to the treatment, and to give you more study medication. You will continue
taking Exisulind during your "off-treatment" period until your PSA reaches a threshold
level. PSA threshold is defined by your primary treatment. If you have had your prostate
removed, the threshold is 1.0 ng/dL. If you have an intact prostate, your threshold is 4
ng/dL. Once your PSA reaches this level, you will restart your hormone suppression treatment
as directed by your doctor.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine whether the addition of exisulind to the treatment of patients who have completed at least ONE cycle of IAS will extend the "off-treatment" cycle.
to be determined
Celestia Higano, MD
University of Washington
United States: Food and Drug Administration
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