Protocol Number: 05-C-0191

Title:

A Phase I Study of Image Guided Dose Escalation with Intensity Modulated Radiation Therapy (IMRT) to Histologically Confirmed Regions of Prostate Cancer

Number:

05-C-0191

Summary:

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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male

Referral Letter Required: No

Population Exclusion(s): Female

Children

Eligibility Criteria:

INCLUSION CRITERIA:

1. ECOG performance status of 0, 1 or 2

2. Pathology report confirming adenocarcinoma of the prostate

3. Risk of lymph node metastasis less than 10% as defined by the Partin tables

4. Tumor visible on MRI

5. No prior surgery, radiation, or chemotherapy for prostate cancer.

6. Age greater than 18 y/o and less than 90 years old.

EXCLUSION CRITERIA:

1. Cognitively impaired patients who cannot give informed consent.

2. Patients with metastatic disease.

3. Contraindication to biopsy

-Bleeding disorder

-PT/PTT greater than or equal to 1.5 times the upper limit of normal

-Platelets less than or equal to 50K

-Artificial heart valve

4. Contraindication to MRI

-Patients weighing greater than 136 kgs (weight limit for the scanner tables)

-Allergy to MR contrast agent

-Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices.

5. Pre-existing and active prostatitis or proctitis

6. Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy.

Special Instructions:

Currently Not Provided

Keywords:

Radiation Therapy

Prostate Cancer

MRI

Fiducial Marker

IMRT

Recruitment Keyword(s):

Prostate Cancer

Condition(s):

Prostatic Neoplasms

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Procedure/Surgery: Radiation Therapy

Procedure/Surgery: MRI

Procedure/Surgery: Prostate Needle Biopsy

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Michalski JM, Winter K, Purdy JA, Perez CA, Ryu JK, Parliament MB, Valicenti RK, Roach M 3rd, Sandler HM, Markoe AM, Cox JD.Toxicity after three-dimensional radiotherapy for prostate cancer with RTOG 9406 dose level IV.Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):735-42.

Pollack A, Zagars GK, Starkschall G, Antolak JA, Lee JJ, Huang E, von Eschenbach AC, Kuban DA, Rosen I. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1097-105.

Pollack A, Hanlon A, Horwitz EM, Feigenberg S, Uzzo RG, Price RA. Radiation therapy dose escalation for prostate cancer: a rationale for IMRT. World J Urol. 2003 Sep;21(4):200-8. Epub 2003 Sep 5. Review.

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