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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT00381966
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria are unchanged from our standard criteria for brachytherapy eligibility:
* Histologically confirmed, locally confined adenocarcinoma of the prostate
* Clinical stages T1b - T2b
* PSA of less than 20 ng/mL
* Combined Gleason score 7 or less, with no individual Gleason score of 5
* The patient has decided to undergo brachytherapy at the Johns Hopkins Hospital as treatment choice for his prostate cancer.
* Karnofsky Performance Status (KPS) \> 70
* Prostate volume by TRUS \< 50 cc
* International Prostate symptom score (IPSS) must be 18 or less
* Signed study-specific consent form prior to registration
Exclusion Criteria:
* Stage T1a, or T3 or greater disease.
* Clinical or Pathological Lymph node involvement (N1).
* Evidence of distant metastases (M1).
* Radical surgery for carcinoma of the prostate.
* Previous Chemotherapy or pelvic radiation therapy
* Previous transurethral resection of the prostate (TURP)
* Significant obstructive symptoms (IPSS greater than 18)
* Hip prosthesis.
* Anatomic or medical condition (such as prior abdominal-perineal resection or anal stricture) which would preclude the use of TRUS
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00381966
Study Brief:
Protocol Section:
NCT00381966