Upstate Active Clinical Trials Seeking Participants
Study title
A Phase III Randomized Study of Hypofractionated 3D-CRT/IMRT Versus Conventionally Fractionated 3D-CRT/IMRT in Patients with Favorable-Risk Prostate Cancer (RTOG 0415)
IRB number
52
What is the purpose of the study?
To compare the effects, good and/or bad, of the standard dose of radiation therapy (41 treatments over 8 weeks) with a higher daily dose (experimental) of radiation (28 treatments over 5 and a half weeks) to see if the effects of the treatments are similar.
Who is eligible?
" Histologically confirmed prostate adenocarcinoma < 180 days prior to randomization
" Clinical stage T1-2c
" Pretreatment PSA < 10 ng/ml; Gleason score < 7
" Performance status 0-1
" No radical surgery or cryosurgery for prostate cancer
" No prior or planned androgen deprivation or bilateral orchiectomy
What is involved if I participate?
- How long is the study?
Study subjects will receive radiation treatments for either 51/2 or 8 weeks, depending on the study group to which they are randomized. After finishing radiation, subjects will return for follow-up exams every 3 months for the first two years, every 6 months for the next 3 years, and annually thereafter. - Is transportation provided or reimbursed?
No - Is parking provided or reimbursed?
No - What tests and procedures are involved?
Prior to study entry: " History and physical exam, including a digital rectal exam (DRE) and an assessment of the subject's ability to carry out his activities of daily living " A biopsy of the prostate to determine the Gleason score (a value that helps determine the stage of prostate cancer) " A blood test to determine PSA (a value that helps determine the stage of prostate cancer); blood tests may also be performed to assess testosterone and alkaline phosphatase levels During the study: " History and physical exam, including an assessment of the subject's ability to carry out activities of daily living (weekly during radiation treatment) " Assessment of any side effects the subject may be experiencing from the treatment (weekly during radiation treatment) Subjects will be "randomized" into one of the study groups described below: " Group 1 (often called "Arm A"): Subjects will receive the standard daily dose of three-dimensional radiation or IMRT. Subjects will receive radiation therapy once daily, 5 days a week, Monday through Friday, for a total of 41 treatments. Each radiation treatment will take 15-30 minutes. " Group 2 (often called "Arm B"): Subjects will receive a higher daily dose of three-dimensional radiation or IMRT. Subjects will receive radiation therapy once daily, 5 days a week, Monday through Friday, for a total of 28 treatments. Each radiation treatment will take 15-30 minutes. When radiation treatments are completed, subjects will need these tests and procedures: " History and physical exam, including a digital rectal exam (DRE) and an assessment of their ability to carry out activities of daily living (every 3 months for the first 2 years, every 6 months for the next 3 years, and then annually) " Assessment of any side effects from the treatment (every 3 months for the first 2 years, every 6 months for the next 3 years, and then annually) " If a subject's disease progresses, his doctor may request a needle biopsy of the prostate to microscopically evaluate response to treatment
Who is the doctor administering the study?
Jeffrey A. Bogart, M.D.
Where will the study take place?
University Hospital, Hill Radiation Oncology, Oswego County Radiation Oncology
Over what time period is the study scheduled to run?
March 2007 until multi-institutional accrural goal is reached
Who can I contact for more information?
- Name: Tara M. Mau
- Phone: 315-464-5264
- Email: maut@upstate.edu
- Fax: 315-464-5943
If you are interested in this trial, please contact the study coordinator or investigator noted above.
