MRI-Guided Radiation Therapy in Treating Patients With Prostate Cancer - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00278356

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Imaging procedures, such as MRI, may help the doctor send x-rays directly to the tumor and nearby lymph nodes and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of MRI-guided radiation therapy in treating patients with prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Procedure: radiation therapy	Phase I

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Pilot Study of Image Guided Prostate and Pelvic Nodal Irradiation With Intensity Modulated Radiation Therapy (IMRT) in Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	28
Study Start Date:	September 2005
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the feasibility of treating the pelvic lymph nodes in patients with prostate cancer treated with intensity-modulated radiotherapy (IMRT).
Determine the maximum tolerated dose of IMRT in these patients.
Determine long term effects and toxicity in patients treated with IMRT.

OUTLINE: This is a pilot, dose-escalation study.

After pathology is available and 2 months of neoadjuvant hormone therapy is complete, patients undergo MRI-guided intensity-modulated radiotherapy (IMRT) to the at-risk or positive lymph nodes 5 days a week for 8.5 weeks.

Cohorts of 3-6 patients receive escalating doses of IMRT 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.

After completion of study treatment, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years to 89 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate
Risk of lymph node metastasis ≥ 10% OR biopsy-proven positive lymph nodes
- No metastatic disease beyond the pelvis
Tumor visible on MRI

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
No bleeding disorders
PT and PTT < 1.5 times upper limit of normal
Platelet count > 50,000/mm^3
No artificial heart valve
Weight ≤ 136 kg
No allergy to magnetic resonance contrast agent
No pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices
No pre-existing or active prostatitis or proctitis
No medical conditions, based on the opinion of the principal investigator, that would preclude study treatment
No cognitively impaired patients who cannot give informed consent

PRIOR CONCURRENT THERAPY:

No prior surgery, radiotherapy, or chemotherapy for this cancer
Must receive neoadjuvant, concurrent, and adjuvant hormone therapy
- Must receive a nonsteroidal anti-androgen, such as flutamide, for approximately 6-8 weeks prior to starting radiotherapy
- Must receive a gonadotropin releasing-hormone agonist for concurrent and adjuvant therapy
  - Adjuvant therapy continues for 3 years or indefinitely
No other concurrent surgery except standard biopsy
No concurrent cytotoxic chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278356

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Aradhana Kaushal, MD

National Cancer Institute (NCI)

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Web site for additional information This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000455048, NCI-05-C-0241, NCI-P6590
Study First Received:	January 16, 2006
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00278356
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009