Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

MRI-Guided Radiation Therapy in Treating Patients With Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Active	18 to 89	NCI	NCI-05-C-0191 NCI-P6551, NCT00227799

Special Category: NIH Clinical Center trial, NCI Web site featured trial

Objectives

Primary

1. Determine the maximum tolerated dose of MRI-guided intensity-modulated external beam radiotherapy in patients with prostate cancer.

Secondary

1. Correlate the radiation response to and/or toxicity of this regimen with genomic and proteomic analyses in these patients.
2. Determine the long-term effects and toxicity of this regimen after selective intra-prostatic dose escalation in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the prostate



• Risk of lymph node metastasis < 10%



• Tumor visible on MRI



• No metastatic disease

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for prostate cancer

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for prostate cancer

Surgery

• No prior surgery for prostate cancer

Patient Characteristics:

Age

• 18 to 89

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Platelet count > 50,000/mm³
• No bleeding disorder

Hepatic

• PT/PTT < 1.5 times upper limit of normal

Renal

• Not specified

Cardiovascular

• No artificial heart valve
• No pacemaker
• No cerebral aneurysm clips

Other

• Weight ≤ 136 kg
• No allergy to magnetic resonance contrast agent
• No pre-existing or active prostatitis or proctitis
• No shrapnel injury or implantable electronic devices
• No other contraindication to biopsy or MRI
• No other medical condition that would preclude study participation
• No cognitive impairment that would preclude giving informed consent

Expected Enrollment

A total of 18-36 patients will be accrued for this study within 2 years.

Outline

This is a dose-escalation study.

Patients undergo MRI-guided intensity-modulated external beam radiotherapy over 10 minutes once daily 5 days a week for 8.5 weeks.

Cohorts of 3-6 patients receive escalating doses of external beam radiotherapy (to areas of histologically confirmed prostate cancer*) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

 [Note: *Areas of the prostate with signal abnormality on MRI that cannot be biopsied or without definite histologic evidence of prostate cancer receive intermediate doses; all other areas of the prostate receive standard doses.]

After completion of study treatment, patients are followed at 2, 4, 8, and 12 weeks, 6, 9, 12, and 18 months, and then every 6 months for up to 5 years.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Aradhana Kaushal, MD, Principal investigator		Ph: 301-496-5457

U.S.A.
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937

Related Information

Web site for additional information
Featured trial article

Registry Information
Official Title		A Phase I Study of Image Guided Dose Escalation with Intensity Modulated Radiation Therapy (IMRT) to Histologically Confirmed Regions of Prostate Cancer
Trial Start Date		2005-08-02
Trial Completion Date		2010-06-05 (estimated)
Registered in ClinicalTrials.gov		NCT00227799
Date Submitted to PDQ		2005-08-02
Information Last Verified		2009-06-07

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