Magnetic Resonance Imaging-Guided Internal Radiation Therapy Before and After External-Beam Radiation 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:	NCT00045344

Purpose

RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Using magnetic resonance imaging (MRI) to guide the placement of radioactive implants into the tumor may result in more effective radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of MRI-guided internal radiation before and after external-beam radiation in treating patients who have prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Procedure: brachytherapy Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer MRI Scans Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase II Study of MR-Guided High Dose Rate Brachytherapy Boosts for Prostate Cancer

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

Study Start Date:

August 2002

Detailed Description:

OBJECTIVES:

Determine the quality of high-dose rate brachytherapy implants performed under magnetic resonance (MR) guidance in patients with prostate cancer undergoing external beam radiotherapy.
Determine the toxic effects of this regimen in these patients.
Determine patient tolerance to this regimen.
Determine the magnitude of spatial distortion in MR images and its impact on dosimetric accuracy in patients treated with this regimen.
Determine time to biochemical failure and survival rate in patients treated with this regimen.

OUTLINE: Patients receive high-dose rate brachytherapy implants with magnetic resonance guidance once before and once after external beam radiotherapy (EBRT). EBRT is administered once daily 5 days a week for 5 weeks. Treatment continues in the absence of disease progression.

Patients are followed at 1 month, every 3 months for 6 months, every 6 months for 1.5 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 18-27 patients will be accrued for this study within 1 year.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate meeting one of the following criteria:
- Gleason score greater than 6
- At least T2b disease
- Prostate-specific antigen (PSA) at least 10 ng/mL
No distant metastases (M1), including bone metastases
No pre-existing significant urinary obstructive symptoms (International Prostate Symptom Score greater than 18)
No pubic arch interference or inadequate access to perineum by MRI

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

No bleeding disorder

Hepatic

Not specified

Renal

See Disease Characteristics
No other urinary condition that would preclude study participation

Cardiovascular

No artificial heart valve
No pacemaker
No cerebral aneurysm clips

Other

Weight no greater than 136 kg
No large TURP defect
No shrapnel injury or implantable electronic devices
No cognitive impairment
No other malignancy except nonmelanoma skin cancer or malignancy that was curatively treated at least 3 years ago with no evidence of recurrence
No other medical condition that would preclude study entry
Must be medically fit for anesthesia

PRIOR CONCURRENT THERAPY:

Biologic therapy

Concurrent PSA vaccine therapy (on protocol NCI-00-C-0154) allowed

Chemotherapy

No concurrent cytotoxic chemotherapy

Endocrine therapy

Concurrent antiandrogen therapy allowed

Radiotherapy

No prior pelvic or prostate radiotherapy

Surgery

More than 6 months since prior transurethral resection of the prostate (TURP)

Other

No concurrent active anticoagulation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045344

Locations

United States, Maryland
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Kevin Camphausen, MD

NCI - Radiation Oncology Branch; ROB

More Information

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

Publications of Results:

Citrin D, Ning H, Guion P, Li G, Susil RC, Miller RW, Lessard E, Pouliot J, Huchen X, Capala J, Coleman CN, Camphausen K, Menard C. Inverse treatment planning based on MRI for HDR prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2005 Mar 15;61(4):1267-75.

Study ID Numbers:	CDR0000256869, NCI-02-C-0207
Study First Received:	September 6, 2002
Last Updated:	December 13, 2008
ClinicalTrials.gov Identifier:	NCT00045344
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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