Prostate CancerNCT02064283
Early Assessment of Treatment Response Using Functional Diffusion Mapping
A study testing Diffusion MRI in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This study will evaluate the feasibility of identifying changes in diffusion MRI characteristics of bone that correlates with response to therapy in men with metastatic prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Diffusion MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Oct 2012
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of prostate cancer.
- Evidence of metastatic disease by bone scan.
- Patients must be initiating systemic therapy for metastatic disease.
- New D2 disease beginning therapy with androgen deprivation.
- CRPC (Castration Resistant Prostate Cancer) beginning systemic non hormonal therapy.
- Patients must be willing to provide the blood samples for the correlative markers.
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- Patients must be able to lie flat in an MRI (Magnetic Resonance Imaging) magnet for 30-60 minutes.
- Life expectancy of 12 weeks or greater.
- All patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and federal guidelines.
Who cannot join
- Contraindication to MRI imaging.
- Patients who require sedation with general anesthesia to undergo MRI imaging.
- Weight greater than 275 pounds.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
About this study
This study will evaluate the feasibility of identifying changes in diffusion MRI characteristics of bone that correlates with response to therapy in men with metastatic prostate cancer.
Read the detailed description
This study will evaluate a special type of MRI (magnetic resonance imaging) scan that measures the movement of water molecules through tissue called diffusion MRI. Researchers are using this new MRI technology to track the diffusion, or movement, of water through tumor tissue, and map these changes as a cancer patient undergoes treatment. Early research seems to indicate that tumor cells restrict the movement of water, so as tumor cells die, the movement of water changes within the tumor. These changes in the movement (diffusion) of water may help doctors determine earlier than traditional tests whether a patient's cancer is responding (getting better) to treatment. This study will evaluate the feasibility of identifying changes in diffusion MRI characteristics of bone that correlates with response to therapy in men with metastatic prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Diffusion MRI
- 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 MRIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Diffusion MRI Assessment | Experimental | Men with newly diagnosed metastatic disease initiating therapy with androgen deprivation, or men with hormone refractory prostate cancer initiating treatment with chemotherapy, will be assessed by diffusion MRI (Magnetic Resonance Imaging) at baseline, 2 weeks and again at 9-12 weeks. Receives: Procedure: Diffusion MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diffusion MRI measurements
Identify changes in Diffusion Magnetic Resonance Imaging (MRI) measurements and correlate the changes with response to therapy.
Measured: Baseline, 2 weeks and 9-12 weeks
Secondary outcomes (2)
Change in units/L of CK18Asp306
Levels of CK18Asp396 can be measured in serum using a commercially available ELISA (Enzyme-linked Immunosorbent Assay). Changes in serum CK18Asp396 (a marker of apoptosis) will be correlated with functional diffusion maps and treatment response.
Measured: Baseline, 2 weeks and 9-12 weeks
Change in levels of bone turnover markers
Correlate the changes in biochemical markers of bone turnover, such as N-telopeptide and bone-specific alkaline phosphatase, with functional diffusion maps and treatment response.
Measured: Baseline, 2 weeks and 9-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startMay 2007
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maha Hussain, MD, FACP, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064283
- Sponsor's protocol ID
- UMCC 2006.111
- Other IDs
- HUM00009498
- Status last verified
- Dec 2014
- First submitted
- 13 Feb 2014
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brisset JC, Hoff BA, Chenevert TL, Jacobson JA, Boes JL, Galban S, Rehemtulla A, Johnson TD, Pienta KJ, Galban CJ, Meyer CR, Schakel T, Nicolay K, Alva AS, Hussain M, Ross BD. Integrated multimodal imaging of dynamic bone-tumor alterations associated with metastatic prostate cancer. PLoS One. 2015 Apr 10;10(4):e0123877. doi: 10.1371/journal.pone.0123877. eCollection 2015.
PubMed 25859981
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Assessment of Treatment Response Using Functional Diffusion Mapping
- ClinicalTrials.gov ID
- NCT02064283
- Acronym / sponsor ID
- UMCC 2006.111
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 17 Feb 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 study will evaluate the feasibility of identifying changes in diffusion MRI characteristics of bone that correlates with response to therapy in men with metastatic prostate cancer.
Detailed description
This study will evaluate a special type of MRI (magnetic resonance imaging) scan that measures the movement of water molecules through tissue called diffusion MRI. Researchers are using this new MRI technology to track the diffusion, or movement, of water through tumor tissue, and map these changes as a cancer patient undergoes treatment. Early research seems to indicate that tumor cells restrict the movement of water, so as tumor cells die, the movement of water changes within the tumor. These changes in the movement (diffusion) of water may help doctors determine earlier than traditional tests whether a patient's cancer is responding (getting better) to treatment. This study will evaluate the feasibility of identifying changes in diffusion MRI characteristics of bone that correlates with response to therapy in men with metastatic prostate cancer.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diffusion MRI Assessment | Experimental | Procedure: Diffusion MRIMen with newly diagnosed metastatic disease initiating therapy with androgen deprivation, or men with hormone refractory prostate cancer initiating treatment with chemotherapy, will be assessed by diffusion MRI (Magnetic Resonance Imaging) at baseline, 2 weeks and again at 9-12 weeks. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of prostate cancer.
- Evidence of metastatic disease by bone scan.
- Patients must be initiating systemic therapy for metastatic disease.
- New D2 disease beginning therapy with androgen deprivation.
- CRPC (Castration Resistant Prostate Cancer) beginning systemic non hormonal therapy.
Key exclusion criteria (3 listed)
- Contraindication to MRI imaging.
- Patients who require sedation with general anesthesia to undergo MRI imaging.
- Weight greater than 275 pounds.
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 MRI | Procedure or surgery | Diffusion MRI Assessment |
Primary outcome
Change in diffusion MRI measurements
Time frame: Baseline, 2 weeks and 9-12 weeks
Identify changes in Diffusion Magnetic Resonance Imaging (MRI) measurements and correlate the changes with response to therapy.
2 secondary outcomes
Change in units/L of CK18Asp306
Time frame: Baseline, 2 weeks and 9-12 weeks
Change in levels of bone turnover markers
Time frame: Baseline, 2 weeks and 9-12 weeks
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 9 Dec 2014.
- Derived from this study: PubMed 25859981Brisset JC, Hoff BA, Chenevert TL, Jacobson JA, Boes JL, Galban S, Rehemtulla A, Johnson TD, Pienta KJ, Galban CJ, Meyer CR, Schakel T, Nicolay K, Alva AS, Hussain M, Ross BD. Integrated multimodal imaging of dynamic bone-tumor alterations associated with metastatic prostate cancer. PLoS One. 2015 Apr 10;10(4):e0123877. doi: 10.1371/journal.pone.0123877. eCollection 2015.
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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.
Maha Hussain, MD, FACP principal investigator
University of Michigan
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 MRI in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center 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 9 inclusion and 3 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 9 Dec 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?
Change in diffusion MRI measurements (time frame: Baseline, 2 weeks and 9-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02064283, which also lists 1 linked publication.
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 9 Dec 2014; AzTrials last refreshed its copy on 4 Nov 2026.