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
18 Years
N/A
Male
Prostate Cancer
Trial Information
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
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.
Inclusion 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)
Type of Study:
Interventional
Study Design:
Primary Purpose: Diagnostic
Outcome Measure:
Status of global hypoxia within the prostate as assessed by blood-oxygen-level-dependent and tissue-oxygen-level-dependent MRI
Safety Issue:
No
Principal Investigator
Robert D. Timmerman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Simmons Cancer Center
Authority:
Unspecified
Study ID:
CDR0000652306
NCT ID:
NCT00963300
Start Date:
September 2009
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- stage IV prostate cancer
- Prostatic Neoplasms
- Anoxia
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