Prostate CancerNCT00796874
Magnetic Resonance Imaging in Detecting Cancer Progression in Patients With Early Stage Prostate Cancer Undergoing Active Surveillance
A study testing active surveillance, imaging biomarker analysis and biopsy in people with Prostate Cancer, run by Roswell Park Cancer Institute.
Trial summary
RATIONALE: Sometimes prostate cancer may not need treatment until it progresses. In this case, active surveillance may be sufficient. Diagnostic procedures, such as magnetic resonance imaging, may be a less invasive method of finding prostate cancer that has progressed. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- active surveillance, imaging biomarker analysis and biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Jul 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
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer
- Low-risk for progression, as evidenced by all of the following:
- Tumor stage ≤ T2a
- PSA ≤ 10 ng/mL
- Gleason score ≤ 7
- Patients informed of treatment options and has already chosen to undergo active surveillance
- No decision to stop active surveillance
- No node-positive or metastatic disease
PATIENT CHARACTERISTICS:
- Willing to undergo MRI
- Willing to undergo prostate biopsy
- No contraindications to MRI that include, but not limited to, any of the following:
- Claustrophobia
- Anxiety
- Presence of metal or shrapnel in the body
- Pacemakers
- Old tattoos with metal-based dye material
- No contraindication to prostate biopsy
- No medical conditions, as deemed by the PI or associates, that would prevent or limit the patient participation on the protocol that include, but not limited to, any of the following:
- Severe coagulopathy
- History of severe bleeding
- Severe coronary artery disease
- Other comorbid conditions that limit life expectancy to less than 2 years
PRIOR CONCURRENT THERAPY:
- No hormone therapy within the past year
- No prior pelvic radiotherapy
- No prior prostate resection including transurethral resection of prostate
- Concurrent participation in other clinical studies (e.g., vitamin D, selenium) allowed provided active surveillance is continued
About this study
Official title: MR Imaging to Stratify Prostate Cancer Progression Risk in Patients on Active Surveillance
RATIONALE: Sometimes prostate cancer may not need treatment until it progresses. In this case, active surveillance may be sufficient. Diagnostic procedures, such as magnetic resonance imaging, may be a less invasive method of finding prostate cancer that has progressed.
PURPOSE: This clinical trial is studying how well magnetic resonance imaging works in detecting cancer progression in patients with early-stage prostate cancer who are undergoing active surveillance.
Read the detailed description
OBJECTIVES:
Primary
- To determine if MRI parameters (initial volume, number and location of image abnormalities, and MR spectroscopy) can improve the ability to stratify cancer progression risk in patients undergoing active surveillance for early-stage prostate cancer.
Secondary
- Determine if changes in non-invasive MRI, validated by MRI-guided biopsies, can accurately detect progression of prostate cancer.
OUTLINE: Patients undergo prostate MRI scans and MRI-guided biopsies of suspicious lesions at baseline. Patients undergo conventional anatomic imaging followed by research biological imaging tests (e.g., magnetic resonance spectroscopic imaging and/or dynamic contrast-enhanced MRI). MRI are repeated at 6 months, 1 year, and then annually until initiation of definitive therapy or for a total of 5 years.
Tissue biopsy with MRI guidance is done at baseline and annually or as clinically indicated based on change in rectal exam, PSA, or maybe done based on change in MR imaging (i.e., new MR lesion or significant change [> 25% increase] in the size of a MR lesion).
Blood samples are collected at baseline and periodically during study for PSA tests.
- Conditions
- Prostate Cancer
- Being tested
- active surveillance, imaging biomarker analysis, biopsy, dynamic contrast-enhanced magnetic resonance imaging, magnetic resonance imaging
- Keywords
- stage I prostate cancer, stage II 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.
active surveillanceOther
Correlative Study
imaging biomarker analysisOther
Correlative Study
biopsyProcedure or surgery
Tissue Removal
dynamic contrast-enhanced magnetic resonance imagingProcedure or surgery
Radiolical Medical Imaging
magnetic resonance imagingProcedure or surgery
Radiolical Medical Imaging
magnetic resonance spectroscopic imagingProcedure or surgery
Radiolical Medical Imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate cancer progression measured by MRI while on active surveillance
Measured: at 6 months, 1 year and than annualy for 5 years
Secondary outcomes (1)
Prostate cancer changes by MRI
Measured: At 6months, 1 year and annually for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: PI decided to terminate study.
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 Roswell Park Cancer InstituteThe 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
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anurag K. Singh, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796874
- Sponsor's protocol ID
- CDR0000618738
- Other IDs
- RPCI-I-124107
- Status last verified
- Jul 2013
- First submitted
- 21 Nov 2008
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Imaging to Stratify Prostate Cancer Progression Risk in Patients on Active Surveillance
- ClinicalTrials.gov ID
- NCT00796874
- Acronym / sponsor ID
- CDR0000618738
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage II prostate cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decided to terminate study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Nov 2008 (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: Sometimes prostate cancer may not need treatment until it progresses. In this case, active surveillance may be sufficient. Diagnostic procedures, such as magnetic resonance imaging, may be a less invasive method of finding prostate cancer that has progressed.
PURPOSE: This clinical trial is studying how well magnetic resonance imaging works in detecting cancer progression in patients with early-stage prostate cancer who are undergoing active surveillance.
Detailed description
OBJECTIVES:
Primary
- To determine if MRI parameters (initial volume, number and location of image abnormalities, and MR spectroscopy) can improve the ability to stratify cancer progression risk in patients undergoing active surveillance for early-stage prostate cancer.
Secondary
- Determine if changes in non-invasive MRI, validated by MRI-guided biopsies, can accurately detect progression of prostate cancer.
OUTLINE: Patients undergo prostate MRI scans and MRI-guided biopsies of suspicious lesions at baseline. Patients undergo conventional anatomic imaging followed by research biological imaging tests (e.g., magnetic resonance spectroscopic imaging and/or dynamic contrast-enhanced MRI). MRI are repeated at 6 months, 1 year, and then annually until initiation of definitive therapy or for a total of 5 years.
Tissue biopsy with MRI guidance is done at baseline and annually or as clinically indicated based on change in rectal exam, PSA, or maybe done based on change in MR imaging (i.e., new MR lesion or significant change [> 25% increase] in the size of a MR lesion).
Blood samples are collected at baseline and periodically during study for PSA tests.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| active surveillanceCorrelative Study | Other | – |
| imaging biomarker analysisCorrelative Study | Other | – |
| biopsyTissue Removal | Procedure or surgery | – |
| dynamic contrast-enhanced magnetic resonance imagingRadiolical Medical Imaging | Procedure or surgery | – |
| magnetic resonance imagingRadiolical Medical Imaging | Procedure or surgery | – |
| magnetic resonance spectroscopic imagingRadiolical Medical Imaging | Procedure or surgery | – |
Primary outcome
Prostate cancer progression measured by MRI while on active surveillance
Time frame: at 6 months, 1 year and than annualy for 5 years
1 secondary outcome
Prostate cancer changes by MRI
Time frame: At 6months, 1 year and annually for 5 years
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 25 Jul 2013.
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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.
Anurag K. Singh, MD principal investigator
Roswell Park Cancer Institute
Questions about this trial
What is this clinical trial studying?
A study testing active surveillance, imaging biomarker analysis and biopsy in people with Prostate Cancer, run by Roswell Park Cancer Institute.
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 25 Jul 2013. 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?
Prostate cancer progression measured by MRI while on active surveillance (time frame: at 6 months, 1 year and than annualy for 5 years). 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 25 Jul 2013.