Status:
WITHDRAWN
Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management
Lead Sponsor:
University of Miami
Conditions:
Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
35-75 years
Brief Summary
1. Using multiparametric MRI Ultrasound-guided or MRI-guided biopsies will allow more accurate sampling of the tumors and therefore will increase the rate of "progression" on early (first and second) ...
Detailed Description
Favorable risk patients will be randomized to one of two active surveillance arms. Stratification will be based on Prostate-specific antigen density (PSAD) (=\< 0.15 vs \> 0.15 ng/mL per mL), and numb...
Eligibility Criteria
Inclusion
- Biopsy confirmed adenocarcinoma of the prostate.
- Biopsy must consist of at least 8 cores.
- Enrollment is =\< 1 year from diagnosis.
- One or two biopsy cores with less than 50% tumor present in each core and Gleason score =\< 6 (3+3).
- Candidate for multiparametric MRI.
- T1-T2a disease based on digital rectal exam.
- No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for \>= 5 years then the patient is eligible.
- Ability to understand and willingness to sign a written informed consent document
- Zubrod performance status \< 2.
- Patients must agree to fill out the psychosocial questionnaires.
- Age \>= 35 and =\< 75 years
Exclusion
- Not biopsy confirmed adenocarcinoma of the prostate.
- Biopsy consists of less than 8 cores.
- Three or more biopsy cores are positive.
- Gleason score \>= 3+4=7.
- A single core has \>= 50% involvement with Gleason score =6 (3+3) or less.
- DCE-MRI study before enrollment.
- Inability to undergo MRI exam.
- Greater than T2a disease based on digital rectal exam.
- Concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for \< 5 years then the patient is ineligible
- Inability to understand or unwilling to sign a written informed consent document.
- Zubrod performance status \>= 2.
- Patient unwilling to fill out the psychosocial questionnaires.
- Age \< 35 or \> 75.
Key Trial Info
Start Date :
August 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01838265
Start Date
August 1 2012
Last Update
December 8 2014
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136