Prostate CancerNCT00851682
Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma
A study testing MRI scan in people with Prostate Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of the present study is to find out if MRI techniques examining (1) the motion of water molecules in the prostate (diffusion sensitive MRI), (2) the difference in blood flow to the prostate (dynamic contrast enhanced MRI), and (3) differences in chemical composition of the prostate (MR spectroscopy), can… Read more about this study
- Who is it for?
- Ages 20 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who have been diagnosed with prostate cancer and are scheduled for radical prostatectomy or for brachytherapy
- patients who have not received any preoperative treatment for their diagnosis of prostate cancer
Who cannot join
- patients with implants that are electronically, magnetically, or mechanically active
- patients with intracranial aneurysm clips
- patients who have undergone cosmetic eyelid surgery
- patients with history of pheochromocytoma, insulinoma and acute glaucoma
- patients with estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The purpose of the present study is to find out if MRI techniques examining (1) the motion of water molecules in the prostate (diffusion sensitive MRI), (2) the difference in blood flow to the prostate (dynamic contrast enhanced MRI), and (3) differences in chemical composition of the prostate (MR spectroscopy), can be used to detect prostate cancer early and non-invasively. Localization of the cancer within the prostate would be of particular importance in focal cryoablation of prostate carcinoma which we hope to improve as a result of this project.
Additional aim of the study is to correlate expression of genes believed to pay a role in prostate cancer with MRI findings.
Read the detailed description
Radical prostatectomy patients will undergo an MRI prior to their scheduled surgery. Ex vivo imaging will be done on prostates once removed. Results from the final pathology with be compared with results of imaging to determine the accuracy of the image analysis in cancer localization and staging.
Brachytherapy patients will undergo an MRI prior to their scheduled procedure. Two areas of suspected cancer and two areas without suspected cancer will be prospectively identified based on the MRI imaging. At the time of brachytherapy, transrectal needle biopsies will be obtained from the previously identified areas. The needle cores will be reviewed by study pathologist to determine the accuracy of the image analysis in cancer localization and staging.
- Conditions
- Prostate Cancer
- Being tested
- MRI scan
- Keywords
- Prostate Cancer, Dynamic Contrast Enhanced MRI, Non-invasive Prostate Cancer Detection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanDevice
Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil.
| Study group | Role | What they receive |
|---|---|---|
| Radical prostatectomy patients | Other | Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer. Receives: Device: MRI scan |
| Brachytherapy patients | Other | Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer. Receives: Device: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Accuracy of Prostate Cancer Detection by MRI Scan.
Data obtained as part of this study could not be analyzed in a meaningful way due to problems with correlation between the cancerous tissue identified by histology and tissue imaging from imaging.
Measured: At time of treatment
Secondary outcomes (1)
Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients.
Ultrasound guidance of transrectal ultrasound biopsy was not attempted.
Measured: At time of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Enrollment was stopped and will not resume. Participants are no longer being examined.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Midwest Stone Institute.
- Responsible party
- Sponsor
- Investigators
- Robert L Grubb, III, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851682
- Sponsor's protocol ID
- HRPO#03-0535
- Status last verified
- Oct 2018
- First submitted
- 25 Feb 2009
- Last updated
- 31 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma
- ClinicalTrials.gov ID
- NCT00851682
- Acronym / sponsor ID
- HRPO#03-0535
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Dynamic Contrast Enhanced MRI, Non-invasive Prostate Cancer Detection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was stopped and will not resume. Participants are no longer being examined.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Midwest Stone Institute.
- Study start
- Jan 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 26 Feb 2009 (estimated)
- Results
- Posted 11 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present study is to find out if MRI techniques examining (1) the motion of water molecules in the prostate (diffusion sensitive MRI), (2) the difference in blood flow to the prostate (dynamic contrast enhanced MRI), and (3) differences in chemical composition of the prostate (MR spectroscopy), can be used to detect prostate cancer early and non-invasively. Localization of the cancer within the prostate would be of particular importance in focal cryoablation of prostate carcinoma which we hope to improve as a result of this project.
Additional aim of the study is to correlate expression of genes believed to pay a role in prostate cancer with MRI findings.
Detailed description
Radical prostatectomy patients will undergo an MRI prior to their scheduled surgery. Ex vivo imaging will be done on prostates once removed. Results from the final pathology with be compared with results of imaging to determine the accuracy of the image analysis in cancer localization and staging.
Brachytherapy patients will undergo an MRI prior to their scheduled procedure. Two areas of suspected cancer and two areas without suspected cancer will be prospectively identified based on the MRI imaging. At the time of brachytherapy, transrectal needle biopsies will be obtained from the previously identified areas. The needle cores will be reviewed by study pathologist to determine the accuracy of the image analysis in cancer localization and staging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical prostatectomy patients | Other | Device: MRI scanPatients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer. |
| Brachytherapy patients | Other | Device: MRI scanPatients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who have been diagnosed with prostate cancer and are scheduled for radical prostatectomy or for brachytherapy
- patients who have not received any preoperative treatment for their diagnosis of prostate cancer
Key exclusion criteria (5 listed)
- patients with implants that are electronically, magnetically, or mechanically active
- patients with intracranial aneurysm clips
- patients who have undergone cosmetic eyelid surgery
- patients with history of pheochromocytoma, insulinoma and acute glaucoma
- patients with estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2
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 |
|---|---|---|
| MRI scanEach patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil. | Device | Brachytherapy patients, Radical prostatectomy patients |
Primary outcome
Improved Accuracy of Prostate Cancer Detection by MRI Scan.
Time frame: At time of treatment
Data obtained as part of this study could not be analyzed in a meaningful way due to problems with correlation between the cancerous tissue identified by histology and tissue imaging from imaging.
1 secondary outcome
Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients.
Time frame: At time of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 L Grubb, III, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI scan in people with Prostate Cancer, run by Washington University School of Medicine 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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 31 Oct 2018. 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?
Yes. Results are posted in the registry (first posted 11 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Improved Accuracy of Prostate Cancer Detection by MRI Scan. (time frame: At time of treatment). 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 31 Oct 2018.