Exisulind and Intermittent Androgen Suppression (ADT) in Biochemical Relapsed Prostate Cancer

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
Prostate-Specific Antigen (PSA). If not already obtained, you will have a bone scan and a
computed tomography scan (CT scan) to establish a baseline.

You will be receiving hormone suppression treatment with monthly injections of a luteinizing
hormone-releasing hormone (LHRH) 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 effective.

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.

Inclusion Criteria:

- A willingness and ability to sign an informed consent document;

- 21 years or of legal age;

- Histologically or cytologically documented prostate cancer.

- ECOG Performance status score of 0 or 1.

- Received at least one cycle of IAS with an LHRH agonist and anti-androgen

- Willingness to remain off chronic NSAIDs (with the exception of ibuprofen or
naproxen), including COX 2 inhibitors and salicylates (e.g., aspirin, mesalamine,
azodisalicylate, salsalate, sulfasalazine) for duration of the study. Patients on low
dose aspirin for cardiovascular prevention may be included in the study.

- Have not taken sulindac (Clinoril™) on regular basis for any indication for one week
prior to enrollment and willing to remain off of sulindac for the duration of the
study.

- Patients with prior radiation must be 2 weeks from their last radiation-treatment and
have recovered from all associated toxicity.

Exclusion Criteria:

- Known hypersensitivity to sulindac (Clinoril™)

- ECOG Performance status score > 1;

- Patients previously on SWOG 9346 or 9921 trials, or any other trials using IAS for
which adding exisulind may be confounding.

- Patients may not have any evidence of hormone-refractory prostate cancer, i.e. 2
consecutive rises in PSA on LHRH agonist and anti-androgen

- Active peptic ulcer disease;

- Use of an investigational medication or device within one month of initiating study
therapy;

- Elevations of serum creatinine to above the upper limit of normal;

- Platelet count < 100,000/L; hgb < 9.0 g/dL; absolute neutrophil count < 1500/mm3

- Known hepatic, biliary tract, renal or hematologic dysfunction which in the opinion of
the Investigator or Sponsor are clinically significant or would obscure laboratory
analyses or are associated with lab abnormalities;

- Any condition or any medication that may interfere with the conduct of the study.

- Bilirubin > ULN. Patients with elevated indirect bilirubin due to Gilbert's Syndrome
will be eligible.

- AST or ALT >2.5 X ULN