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Research and Clinical Trials

Title  
RTOG 0521: A Phase III Protocol of Androgen Suppression (AS) and 3DCTR/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer
Brief Description  
This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer. This project is being conducted at the following locations: Carolinas Medical Center/Blumenthal Cancer Center, Carolinas Hematology-Oncology Associates, and Mecklenburg Medical Group.
Who may be Eligible  

Patients, ages 18 and over, may be eligible if they meet the following criteria:
  • Histologically confirmed prostate cancer at high-risk for recurrence within the past 180 days as determined by 1 of the following combinations (risk groups):
    • Gleason score = 9, prostate-specific antigen (PSA) = 150 ng/mL, and any T stage
    • Gleason score 8, PSA < 20 ng/mL, and stage = T2
    • Gleason score 8, PSA 20-150 ng/mL, and any T stage
    • Gleason score 7, PSA 20-150 ng/mL, and any T stage
  • Clinically negative lymph nodes by imaging (pelvic CT scan or pelvic MRI), nodal sampling, or dissection within 90 days prior to study entry
    • Equivocal or questionable lymph nodes = 1.5 cm by imaging allowed
    • Positive lymph nodes by capromab pendetide (ProstaScint^®) scan with a corresponding lymph node = 1.5 cm by CT scan or MRI allowed
  • PSA = 150 ng/mL
    • Cannot have been obtained during any of the following time points:
      • 10-day period after prostate biopsy
      • After initiation of hormonal therapy
      • Within 30 days after discontinuation of finasteride
      • Within 90 days after discontinuation of dutasteride
  • No distant metastases by physical exam and bone scan
    • Equivocal bone scan findings allowed if plain films are negative
  • No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy
  • No prior systemic chemotherapy for prostate cancer
    • Prior chemotherapy for a different cancer is allowed
  • No prior radiotherapy, including brachytherapy, to the region of prostate cancer that would result in overlap of radiotherapy fields
Speciality/Disorder  
Genitourinary Cancer
IRB Number  
02-08-02A
Principal Investigator  
Mahoney, John

For More Information, Contact  Delois  , DeShazo
Phone:  (704) 355-1342  Fax:  (704) 355-1353  
Email:  Delois.DeShazo @carolinashealthcare.org
Address:1100 South Tryon Street Suite 220 Charlotte, NC 28203
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