Trial Information

A Phase I Study of Image Guided Dose Escalation With Intensity Modulated Radiation Therapy (IMRT) to Histologically Confirmed Regions of 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 MR biological images and co-register tissue in prostate cancer
patients.

OBJECTIVES:

- The scientific objective of this protocol is to determine the maximum tolerated dose
(MTD) of external beam radiation to regions of interest within the prostate based acute
toxicity.

- 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.

ELIGIBILITY:

-Patients with prostate cancer without evidence of metastasis will be eligible for this
study.

DESIGN:

- This phase I trial will use intensity modulated radiation therapy (IMRT) to deliver
escalating doses of external beam radiation to regions of histologically confirmed
prostate cancer. The study will be conducted using a standard 3-6 dose-escalation with
an initial 3 patients in each dose cohort and the potential expansion of the cohort to
6 patients.

- Anatomic MRI and MR biological images, such as MRS, will be obtained Tissue will be
acquired from sites of interest, with biopsy locations precisely translated
(co-registered) to an MR image of reference. Tissue samples will be processed for cDNA
microarray testing and stored for future analysis in the Radiation Oncology Branch,
NCI. A gold seed will be left at the biopsy site as a fiducial marker to direct future
radiation therapy. If necessary, additional fiducial markers will be placed for target
localization during treatment.

- Once MR guided biopsies are obtained and fiducial markers placed, the patient will
undergo a standard CT simulation for radiation therapy treatment planning. The MR and
CT images will be fused. Areas of pathologically confirmed malignancy will undergo dose
escalation as described below. Areas of image abnormality that could not be biopsied or
were without definite pathologic evidence of malignancy will be given intermediate
doses. The remainder of the prostate gland will receive standard dose (7560 cGy.)

- The trial will accrue 18 to 36 patients with an anticipated accrual period of 2 years.