Magnetic Resonance Imaging in Detecting Cancer Progression in Patients With Early Stage Prostate Cancer Undergoing Active Surveillance

Study Overview
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Brief Summary
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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
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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.

Official Title
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MR Imaging to Stratify Prostate Cancer Progression Risk in Patients on Active Surveillance

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: active surveillance
* Other: imaging biomarker analysis
* Procedure: biopsy
* Procedure: dynamic contrast-enhanced magnetic resonance imaging
* Procedure: magnetic resonance imaging
* Procedure: magnetic resonance spectroscopic imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: active surveillance|Correlative Study|
|Other: imaging biomarker analysis|Correlative Study|
|Procedure: biopsy|Tissue Removal|
|Procedure: dynamic contrast-enhanced magnetic resonance imaging|Radiolical Medical Imaging|
|Procedure: magnetic resonance imaging|Radiolical Medical Imaging|
|Procedure: magnetic resonance spectroscopic imaging|Radiolical Medical Imaging|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate cancer progression measured by MRI while on active surveillance |  | at 6 months, 1 year and than annualy for 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate cancer changes by MRI |  | At 6months, 1 year and annually for 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I prostate cancer, stage II prostate cancer