Trial Information

A Pilot Study of Image Guided Prostate and Pelvic Nodal Irradiation With Intensity Modulated Radiation Therapy (IMRT) in Prostate Cancer

BACKGROUND:

-This study represents a progression from findings in four previous NCI ROB protocols
(02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to
develop techniques to obtain Magnetic Resonance (MR) biological images and co-register
tissue in prostate cancer patients.

OBJECTIVES:

-The primary objective of the first portion of this study is to assess the feasibility of
using IMRT to treat the at-risk lymph nodes in prostate cancer. Also, if feasible, we hope
optimize this technique with experience.

ELIGIBILITY:

-This is a study of image guided, targeted radiation therapy in patients with high risk of
nodal metastases from prostate cancer. Patients with prostate cancer who have more than 15%
risk of lymph node (as defined by the Partin tables) metastasis will be eligible for this
study.

DESIGN:

- On the first 10 patients, we will perform approximately 5CT simulations throughout the
course of their therapy. On each simulation, the initial treatment plan will be re-run.
The dose-volume data from target and normal tissues will then be re-analyzed. From this
analysis we will be better able to determine the size of margins needed to account for
organ motion and changes such as varying amounts of gas in the bowel and fluid in the
bladder. To the best of our knowledge, no such analyses have been published.

- If the initial part of this trial is feasible, we will proceed to a phase I dose
escalation trial of radiation to the at-risk lymph nodes. The primary statistical
objective of the phase I portion of this study is to estimate the Maximum Tolerated
Dose (MTD) of external beam radiation based on evaluating acute toxicity. The study
will be conducted with a dose-escalation design with 3 patients in each dose cohort. If
fewer than 2 of 3 patients experience an acute DLT than patients will be accrued to the
next dose cohort. If 2 or more of 3 patients experience a DLT then the MTD will be
exceeded and the prior, lower dose cohort will be considered the MTD. Secondary
objectives of this study are to relate patterns in gene and protein expression to
response and toxicity and to evaluate the frequency of late term toxicity.

- Specific procedures and risks will be described in a separate consent to be obtained at
the time of biopsy. Tissue samples will be processed for cDNA microarray testing and
stored for future analysis in the Radiation Oncology Branch, NCI.

- Anatomic Magnetic Resonance Imaging (MRI) and MR biological images of the prostate and
pelvis will be obtained and tissue will be acquired with biopsy locations precisely
translated (co-registered) to an MR image of reference. A fiducial marker (gold seed)
will be left at the biopsy site as a fiducial marker to direct future radiation therapy
to the prostate. If necessary, additional fiducial markers will be placed for prostate
localization during treatment.