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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT00911118
Eligibility Criteria:
Inclusion Criteria:
Eligibility is not restricted to MSKCC to confirm biopsy/diagnosis. Participating institution testing is sufficient.
* Low and intermediate risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines.
* Low risk patients will be defined as:
* PSA \< or = to 10 ng/ml and
* Gleason score = 6 and
* Clinical Stage \< or = to T2a
* Intermediate risk patients will be defined as:
* PSA 10-20 ng/ml or
* Gleason score = 7 or
* Clinical stage T2b/T2c
Additionally, patients will be required to meet the following criteria:
* Age \> or = to 18
* KPS \> or = to 70
* Pre-treatment endorectal coil MRI or CT (MRI preferred) at MSKCC showing no definite evidence of radiographic T3, T4, or N1 disease
* Prostate size \< or = to 60 cc
* International Prostate Symptom Score \< or = to 15
Exclusion Criteria:
* Prior androgen deprivation therapy for prostate cancer
* Elective pelvic lymph node irradiation
* KPS \< 70
* Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease
* Presence of distant metastasis as determined by:
o alkaline phosphatase \> or = to ULN or
* whole body bone scan positive for osseous metastases
* Prior history of transurethral resection of the prostate
* Prior history of chronic prostatitis
* Prior history of urethral stricture
* Prior history of pelvic irradiation
* History of inflammatory bowel disease
* Unable to give informed consent
* Unable to complete quality of life questionnaires Abnormal complete blood count. Any of the following
* Platelet count less than 75,000/ml
* Hb level less than 10 gm/dl
* WBC less than 3.5/ml
* Abnormal renal function tests (creatinine \> 1.5)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00911118
Study Brief:
Protocol Section:
NCT00911118