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 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT01100866
Eligibility Criteria:
Inclusion Criteria:
* Men 18 years or older (19 years in BC) with a histologic diagnosis of clinically localized prostate cancer prior to radical prostatectomy as defined by:
1. Clinical state T1-T2
2. PSA \<20
3. Gleason score ≤ 7
* ECOG performance status of 0-1.
* Life expectancy greater than 10 years.
* Able to understand and give informed consent.
* Laboratory values must be as follows:
1. White blood cell count: ≥ 3,000/mm\^3
2. Absolute granulocyte count: ≥ 1,500/mm\^3
3. Platelets: ≥ 100,000/mm\^3
4. Hemoglobin: ≥ 12g/dL
5. Serum creatinine: ≤ 1.5 x ULN
6. AST: ≤ 2 x ULN
7. ALT: ≤ 2 x ULN
8. Serum calcium: ≤ ULN
9. Total bilirubin: ≤ 1.5 x ULN
Exclusion Criteria:
* Patients who are receiving any other investigational therapy.
* Patients who have received or are receiving any other treatment for their prostate cancer.
* Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
* Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
* Histologic evidence of small cell carcinoma of the prostate.
* Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible for study.
* Patients who are receiving any androgens, estrogens or progestational agents.
* Patients with a known hypersensitivity to pomegranates or composites of the capsules/placebo: hydroxypropyl methylcellulose, silicon dioxide or aerosol.
* Patients who are taking any drugs or natural health products which might impact biochemical tests (some examples include: spironolactone, aprepitant, bexarotene, clarithromycin, itraconazole, ketoconazole, St. John's wort). A washout period of 30 days prior to commencing the study would be necessary for these compounds if required.
* Patients who have chronic active hepatitis.
* Medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
19 Years
Study:
NCT01100866
Study Brief:
Protocol Section:
NCT01100866