- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00796874
Magnetic Resonance Imaging in Detecting Cancer Progression in Patients With Early Stage Prostate Cancer Undergoing Active Surveillance
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.
Study Overview
Status
Conditions
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 Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prostate cancer progression measured by MRI while on active surveillance
Time Frame: at 6 months, 1 year and than annualy for 5 years
|
at 6 months, 1 year and than annualy for 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prostate cancer changes by MRI
Time Frame: At 6months, 1 year and annually for 5 years
|
At 6months, 1 year and annually for 5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000618738
- RPCI-I-124107 (OTHER: Roswell Park Cancer Institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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