Clinical trial NCT00963300: MRI in Assessing Hypoxia in Patients With Localized Prostate Cancer Undergoing Stereotactic Body Radiation Therapy
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2009-08-21
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Status of global hypoxia within the prostate as assessed by blood-oxygen-level-dependent and tissue-oxygen-level-dependent MRI
measure: Tumor vasculature and metabolism within the prostate as assessed by dynamic contrast-enhanced MRI and magnetic resonance spectroscopic imaging
measure: Correlation of prostate and normal tissue hypoxia before treatment with clinical outcomes after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Simmons Cancer Center
name: Robert D. Timmerman, MD
role: PRINCIPAL_INVESTIGATOR
References: