MRI in Assessing Hypoxia in Patients With Localized Prostate Cancer Undergoing Stereotactic Body Radiation Therapy

Prostate Cancer Clinical Trial

Official title:

Hypoxia Assessment in Localized Prostate Cancer: A Companion Protocol to a Phase II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00963300
• Other study ID #: SCCC-062009-014
• Secondary ID: CDR0000652306
• Status: Withdrawn
• Phase: N/A
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: November 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Diagnostic procedures, such as MRI, may help measure oxygen levels in tumor cells. It may also help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This clinical trial is studying how well MRI works in assessing hypoxia in patients with localized prostate cancer undergoing stereotactic body radiation therapy.

Description:

OBJECTIVES:

• To characterize the status of global hypoxia within the prostate before stereotactic body radiotherapy (SBRT) as assessed by blood-oxygen-level-dependent and tissue-oxygen-level-dependent MRI.

• To characterize tumor vasculature and metabolism within the prostate before SBRT as assessed by dynamic contrast-enhanced MRI and magnetic resonance spectroscopic imaging, respectively.

• Correlate prostate and normal tissue hypoxia before SBRT with clinical outcomes (toxicity and biochemical [PSA] control) after SBRT.

OUTLINE: Within 1-3 weeks before beginning stereotactic body radiotherapy, patients undergo T2-weighted anatomic MRI, magnetic resonance spectroscopic imaging, blood-oxygen-level-dependent and tissue-oxygen-level-dependent MRI, and dynamic contrast-enhanced MRI.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Biopsy proven adenocarcinoma of the prostate

• Localized disease

• Scheduled to undergo treatment with stereotactic body radiotherapy (SBRT) on a phase II clinical trial

• Has not yet started SBRT

PATIENT CHARACTERISTICS:

• Serum creatinine = 1.2 mg/dL

• No claustrophobia

• No other contraindication to MRI (e.g., implanted pacemaker device)

• No known allergy to MRI contrast

PRIOR CONCURRENT THERAPY:

• No prior treatment for prostate cancer (e.g., hormonal therapy or chemotherapy)

Related Conditions & MeSH terms

• Hypoxia
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• blood-oxygen-level-dependent functional magnetic resonance imaging

• dynamic contrast-enhanced magnetic resonance imaging

• magnetic resonance spectroscopic imaging

• tissue-oxygen-level-dependent functional magnetic resonance imaging

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Status of global hypoxia within the prostate as assessed by blood-oxygen-level-dependent and tissue-oxygen-level-dependent MRI
Primary	Tumor vasculature and metabolism within the prostate as assessed by dynamic contrast-enhanced MRI and magnetic resonance spectroscopic imaging
Primary	Correlation of prostate and normal tissue hypoxia before treatment with clinical outcomes after treatment