Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT00283803
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
21 Years
Study:
NCT00283803
Study Brief:
Protocol Section:
NCT00283803