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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00963300

Enrollment

Registered

2009-08-21

Start date

2009-09-30

Completion date

2011-09-30

Last updated

2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

PROCEDUREblood-oxygen-level-dependent functional magnetic resonance imaging

PROCEDUREdynamic contrast-enhanced magnetic resonance imaging

PROCEDUREmagnetic resonance spectroscopic imaging

PROCEDUREtissue-oxygen-level-dependent functional magnetic resonance imaging

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 120 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026