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:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT02344667
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of adenocarcinoma of the prostate
* Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores ≤ 7
* Clinical stage T1-2b (AJCC 7th edition)
* PSA ≤ 10 ng/mL. PSA should not be obtained within 10 days after prostate biopsy.
* ECOG Performance Status 0-1
Exclusion Criteria:
* Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
* Evidence of distant metastases
* Regional lymph node involvement
* Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer. Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
* Previous hormonal therapy, such as LHRH agonists or LHRH antagonists, anti-androgens, estrogens, or surgical castration
* Use of finasteride or dutasteride within 30 days prior to registration. PSA should not be obtained prior to 30 days after stopping finasteride or dutasteride.
* Previous or concurrent cytotoxic chemotherapy for prostate cancer
* Age \< 18
* Patient unable to provide study-specific informed consent
* Inability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02344667
Study Brief:
Protocol Section:
NCT02344667