Prostate CancerNCT00963300
MRI in Assessing Hypoxia in Patients With Localized Prostate Cancer Undergoing Stereotactic Body Radiation Therapy
A study testing blood-oxygen-level-dependent functional magnetic resonance imaging, dynamic contrast-enhanced magnetic resonance imaging and magnetic resonance spectroscopic imaging in people with Prostate Cancer, run by University of Texas Southwestern Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- blood-oxygen-level-dependent functional magnetic resonance imaging, dynamic contrast-enhanced magnetic resonance imaging and magnetic resonance spectroscopic imaging
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
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)
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- 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
- 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
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood-oxygen-level-dependent functional magnetic resonance imagingProcedure or surgery
dynamic contrast-enhanced magnetic resonance imagingProcedure or surgery
magnetic resonance spectroscopic imagingProcedure or surgery
tissue-oxygen-level-dependent functional magnetic resonance imagingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startSep 2009 (estimated)
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Project Never Initiated - no human subjects were enrolled and no data regarding humans was collected or studied
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert D. Timmerman, MD, Principal investigator, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963300
- Sponsor's protocol ID
- SCCC-062009-014
- Other IDs
- CDR0000652306
- Status last verified
- Nov 2018
- First submitted
- 20 Aug 2009
- Last updated
- 26 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00963300
- Acronym / sponsor ID
- SCCC-062009-014
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project Never Initiated - no human subjects were enrolled and no data regarding humans was collected or studied
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Sep 2009 (estimated)
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood-oxygen-level-dependent functional magnetic resonance imaging | Procedure or surgery | – |
| dynamic contrast-enhanced magnetic resonance imaging | Procedure or surgery | – |
| magnetic resonance spectroscopic imaging | Procedure or surgery | – |
| tissue-oxygen-level-dependent functional magnetic resonance imaging | Procedure or surgery | – |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D. Timmerman, MD principal investigator
Simmons Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing blood-oxygen-level-dependent functional magnetic resonance imaging, dynamic contrast-enhanced magnetic resonance imaging and magnetic resonance spectroscopic imaging in people with Prostate Cancer, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Status of global hypoxia within the prostate as assessed by blood-oxygen-level-dependent and tissue-oxygen-level-dependent MRI. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.