Adenocarcinoma of the ProstateNCT02237612
Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer
A study testing diffusion-weighted magnetic resonance imaging and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Stage IIA Prostate Cancer, run by University of Southern California at 1 site in United States.
Trial summary
This pilot clinical trial studies how well diffusion-weighted magnetic resonance imaging (MRI) works in staging patients with prostate cancer that has not spread to nearby lymph nodes or other parts of the body. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- What is being tested?
- diffusion-weighted magnetic resonance imaging and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 2013
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-documented adenocarcinoma of the prostate which is intermediate or high risk, defined as possessing one or more of the following features:
- Gleason >= 7
- > 50% biopsy cores +
- Prostate-specific antigen (PSA) >= 10
- Interested in undergoing a radical prostatectomy as definitive management for prostate cancer
- No clinical or radiographic evidence for distant metastatic disease
- In subjects with PSA < 20 no radiographic staging is required in the absence of clinical symptoms for distant metastatic disease; for those with PSA > 20, a bone scan must document lack of concern for bone involvement
Who cannot join
- Ineligible for surgery due to cardiac, pulmonary, or other major comorbidity factor
- History of claustrophobia
- Pacemaker or other implanted metal objects which would make subject ineligible for MRI, per standard criteria
- Unable to give written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Diffusion-Weighted MRI for Staging in Localized Prostate Cancer: A Pilot Study
This pilot clinical trial studies how well diffusion-weighted magnetic resonance imaging (MRI) works in staging patients with prostate cancer that has not spread to nearby lymph nodes or other parts of the body. New imaging techniques, such as diffusion-weighted MRI, may be a less invasive way of predicting the stage and grade of prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the sensitivity and specificity of diffusion-weighted MRI for pathologic T3 stage prostate cancer using a 3 Tesla (3T) magnet with a surface coil.
OUTLINE:
Patients undergo diffusion-weighted MRI of the pelvis.
- Being tested
- diffusion-weighted magnetic resonance imaging, laboratory biomarker analysis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffusion-weighted magnetic resonance imagingProcedure or surgery
Also called diffusion-weighted MRI
Undergo diffusion-weighted MRI
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (diffusion-weighted MRI) | Experimental | Patients undergo diffusion-weighted MRI of the pelvis. Receives: Procedure: diffusion-weighted magnetic resonance imaging; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients found to have extracapsular extension and seminal vesicle involvement using Diffusion-Weighted MRI
Patients will be imaged using diffusion-weighted MR. Findings will be correlated with histopathologic findings at biopsy and/or prostatectomy.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startJan 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tanya Dorff, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237612
- Sponsor's protocol ID
- 4P-08-4
- Other IDs
- NCI-2014-01848, HS-08-00413-CR004, HS-08-00413, 4P-08-4, P30CA014089
- Status last verified
- Sep 2014
- First submitted
- 4 Sep 2014
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion-Weighted MRI for Staging in Localized Prostate Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT02237612
- Acronym / sponsor ID
- 4P-08-4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Sep 2014 (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.
This pilot clinical trial studies how well diffusion-weighted magnetic resonance imaging (MRI) works in staging patients with prostate cancer that has not spread to nearby lymph nodes or other parts of the body. New imaging techniques, such as diffusion-weighted MRI, may be a less invasive way of predicting the stage and grade of prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the sensitivity and specificity of diffusion-weighted MRI for pathologic T3 stage prostate cancer using a 3 Tesla (3T) magnet with a surface coil.
OUTLINE:
Patients undergo diffusion-weighted MRI of the pelvis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (diffusion-weighted MRI) | Experimental | Procedure: diffusion-weighted magnetic resonance imaging, Other: laboratory biomarker analysisPatients undergo diffusion-weighted MRI of the pelvis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Biopsy-documented adenocarcinoma of the prostate which is intermediate or high risk, defined as possessing one or more of the following features:
- Interested in undergoing a radical prostatectomy as definitive management for prostate cancer
- No clinical or radiographic evidence for distant metastatic disease
Key exclusion criteria (4 listed)
- Ineligible for surgery due to cardiac, pulmonary, or other major comorbidity factor
- History of claustrophobia
- Pacemaker or other implanted metal objects which would make subject ineligible for MRI, per standard criteria
- Unable to give written informed consent
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 |
|---|---|---|
| diffusion-weighted magnetic resonance imagingAlso: diffusion-weighted MRIUndergo diffusion-weighted MRI | Procedure or surgery | Diagnostic (diffusion-weighted MRI) |
| laboratory biomarker analysisCorrelative studies | Other | Diagnostic (diffusion-weighted MRI) |
Primary outcome
Number of patients found to have extracapsular extension and seminal vesicle involvement using Diffusion-Weighted MRI
Time frame: Baseline
Patients will be imaged using diffusion-weighted MR. Findings will be correlated with histopathologic findings at biopsy and/or prostatectomy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
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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.
Tanya Dorff principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diffusion-weighted magnetic resonance imaging and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Stage IIA Prostate Cancer, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients found to have extracapsular extension and seminal vesicle involvement using Diffusion-Weighted MRI (time frame: Baseline). 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 11 Sep 2014.