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Investigator(s):
Aradhana Kaushal, M.D. Principal Investigator Phone: 301-496-5457 kaushala@mail.nih.gov
Referral Contact(s):
Deborah McNally, R.N. Research Nurse Phone: 301-496-5457 cooleyd@navmed.nci.nih.gov

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Primary Eligibility:

• Adenocarcinoma of the prostate with risk of lymph node metastasis greater than or equal to 10 percent and no metastatic disease beyond the pelvis
• ECOG performance status of 0, 1, or 2
• No prior surgery, radiation, or chemotherapy for prostate cancer
• Tumor visible on MRI
• Age greater than 18 and less than 90 years
• No pre-existing or active prostatitis or proctitis

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Study Outline:

Part I

• Patients receive 4500 cGy of intensity modulated radiation therapy (IMRT) to the pelvic lymph nodes
• Participants receive 7560 cGy to the prostate gland

Part II

A phase I dose escalation trial of radiation to the at-risk lymph nodes

• Participants will receive external beam radiation to the pelvic region until the maximum tolerated dose (MTD) is determined

Both Part I and Part II

• Participants undergo MRI imaging and tumor biopsies from sites of interest; fiducial markers may be left at biopsy site
• Participants with areas of image abnormalities receive dose escalation IMRT
• Participants are evaluated at 2, 4, 8, and 12 weeks upon completion of therapy
• Participants are then evaluated at 6, 9, 12, 18, and every 6 months until 36 months; thereafter, follow-ups will be once a year for 5 years

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/10/09
Updated: 12/5/07