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 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT01617161
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with histologically confirmed adenocarcinoma of the prostate based on core-biopsy within 1 year of study entry from TRUS
* Clinical stages T1c to T2c
* PSA \<20, within 6 months of study entry
* Participants who are currently receiving Dutasteride (or have received it within the last 90 days) or Finasteride (or have received it within the last 30 days) must have a PSA of ≤ 10
* Gleason score ≤6, 3 + 4 = 7, or 4 + 3 = 7
* ECOG Performance Status 0-1 as documented within 3 months prior to study entry
* Must have complete history and physical examination within 45 days of study entry and digital rectal examination of prostate within 180 days of study entry
Exclusion Criteria:
* Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa
* Prior or planned androgen deprivation or bilateral orchiectomy
* Distant metastases, or clinically or pathologically involved lymph nodes confirmed by a CT scan within 365 days of study entry
* Hip prosthesis, inflammatory bowel disease or connective tissue disorder such as active scleroderma or lupus
* Individuals with a history of other malignancies are ineligible unless 1) they have been disease-free for at least 5 years OR 2) are deemed by the investigator to be at low risk for recurrence of that malignancy with no plans for adjuvant systemic chemotherapy and/or radiation therapy and have received overall principal investigator approval.
* Individuals who have AIDS (CD4 \< 200 or an AIDS-defining illness) or are HIV positive and not on HAART therapy are ineligible.
* Major medical or psychiatric illness
* Individuals with any of the following conditions are excluded from this study:
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
* Transmural myocardial infarction within the last 6 months.
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
* History of Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects within the last 12 months
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01617161
Study Brief:
Protocol Section:
NCT01617161