Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Duke University
With
Virginia Commonwealth University
Age
18–70
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Subjects must have
biopsy-confirmed "high-risk" prostate cancer, defined as A. PSA \> 20, B. Gleason Score (GS) \>/= 8, and/or C. Clinical stage T3 disease per AJCC Staging Manual, 6th edition; or D. At least two out of three of the following: PSA 10-19.9, GS = 7, or clinical stage = T2b / T2c.
a negative bone scan,
be medically fit to undergo surgery as determined by treating urologist,
age \> 18,
KPS must be \>/= 80,
no prior pelvic radiation therapy, chemotherapy, or androgen deprivation,
no prior invasive malignancy, except non- melanomatous skin cancer unless disease free for a minimum of 5 years. Carcinoma in-situ of the bladder or head and neck region is permissible.
Subjects must freely sign informed consent to enroll in the study.
You may not be if
prior pelvic radiation therapy, chemotherapy, or androgen deprivation,
prior invasive malignancy, except non- melanomatous skin cancer, carcinoma in-situ of the bladder or head and neck region, unless disease free for a minimum of 5 years.
Metastatic disease as demonstrated by bone scan, CT scan or MRI of the pelvis, or chest x-ray.
Pathologically documented positive pelvic lymph nodes. If Pre-operative CT scan or MRI (ordered at the discretion of the treating physicians) demonstrates lymph nodes which are suspicious for involvement, then biopsy must be undertaken and nodes proven negative before patient can enroll on this trial.
Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
History of prior pelvic radiation therapy.
History of androgen deprivation therapy or chemotherapy.
