Back to resultsMagnetic Resonance Imaging in Detecting Cancer Progression in Patients With Early Stage Prostate Cancer Undergoing Active Surveillance
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
active surveillance
imaging biomarker analysis
biopsy
dynamic contrast-enhanced magnetic resonance imaging
magnetic resonance imaging
magnetic resonance spectroscopic imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring stage I prostate cancer, stage II prostate cancer
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Prostate cancer progression measured by MRI while on active surveillance
Secondary Outcome Measures
Prostate cancer changes by MRI
Full Information
NCT ID
NCT00796874
First Posted
November 21, 2008
Last Updated
July 24, 2013
Sponsor
Roswell Park Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT00796874
Brief Title
Magnetic Resonance Imaging in Detecting Cancer Progression in Patients With Early Stage Prostate Cancer Undergoing Active Surveillance
Official Title
MR Imaging to Stratify Prostate Cancer Progression Risk in Patients on Active Surveillance
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Withdrawn
Why Stopped
PI decided to terminate study.
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage I prostate cancer, stage II prostate cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
active surveillance
Intervention Description
Correlative Study
Intervention Type
Other
Intervention Name(s)
imaging biomarker analysis
Intervention Description
Correlative Study
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Description
Tissue Removal
Intervention Type
Procedure
Intervention Name(s)
dynamic contrast-enhanced magnetic resonance imaging
Intervention Description
Radiolical Medical Imaging
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Intervention Description
Radiolical Medical Imaging
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance spectroscopic imaging
Intervention Description
Radiolical Medical Imaging
Primary Outcome Measure Information:
Title
Prostate cancer progression measured by MRI while on active surveillance
Time Frame
at 6 months, 1 year and than annualy for 5 years
Secondary Outcome Measure Information:
Title
Prostate cancer changes by MRI
Time Frame
At 6months, 1 year and annually for 5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anurag K. Singh, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Magnetic Resonance Imaging in Detecting Cancer Progression in Patients With Early Stage Prostate Cancer Undergoing Active Surveillance
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