Status:
WITHDRAWN
Magnetic Resonance Imaging in Detecting Cancer Progression in Patients With Early Stage Prostate Cancer Undergoing Active Surveillance
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00796874
Start Date
October 1 2008
End Date
July 1 2013
Last Update
July 25 2013
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