Prostate Cancer
A Phase I Study of Image Guided Dose Escalation With Intensity Modulated Radiation Therapy (IMRT) to Histologically Confirmed Regions of Prostate Cancer
NCI-05-C-0191
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Investigator(s): |
Aradhana Kaushal, M.D. Principal Investigator Phone: 301-496-5457 kaushala@mail.nih.gov
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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, risk of lymph node metastasis less than 10%
- ECOG performance status of 0, 1, or 2
- Tumor visible on MRI
- No prior surgery, radiation, or chemotherapy for prostate cancer
- Age greater than 18 and less than 90 years
- No pre-existing or active prostatitis or proctitis
Treatment Plan:
- Participants undergo MRI imaging and biopsies from the site of interest
- A fiducial marker will be left at the biopsy site to direct future radiation therapy
- Areas of the prostate with pathologically confirmed malignancy will undergo dose escalation with IMRT
- Areas of the prostate with abnormalities not available for biopsy or without definite pathologic evidence of disease will receive intermediate doses; remainder of the prostate gland will receive standard dose
- Participants will be evaluated at 2, 4, 8, and 12 weeks for acute effects of radiation therapy upon completion of therapy
- Patients will be evaluated at 6, 9, 12, 18 and every 6 months afterward for late effects until 36 months; thereafter, follow-ups will be once a year until for 5 years
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: 6/2/08
Updated: 8/22/07