NCT00963300

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2009

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2009

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

August 20, 2009

Last Update Submit

November 21, 2018

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancer

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

blood-oxygen-level-dependent functional magnetic resonance imagingPROCEDURE
dynamic contrast-enhanced magnetic resonance imagingPROCEDURE
magnetic resonance spectroscopic imagingPROCEDURE
tissue-oxygen-level-dependent functional magnetic resonance imagingPROCEDURE

Eligibility Criteria

Age18 Years - 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Robert D. Timmerman, MD

    Simmons Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2009

First Posted

August 21, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

November 26, 2018

Record last verified: 2018-11