NCT00796874WithdrawnNot Applicable
MR Imaging to Stratify Prostate Cancer Progression Risk in Patients on Active Surveillance
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Prostate cancer progression measured by MRI while on active surveillance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion 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
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Prostate cancer progression measured by MRI while on active surveillance
Time Frame: at 6 months, 1 year and than annualy for 5 years
Secondary Outcomes
- Prostate cancer changes by MRI(At 6months, 1 year and annually for 5 years)
Investigators
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