Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management

Withdrawn before enrolling

Conditions studied: Prostate Cancer, Prostate Adenocarcinoma

In brief

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) surveillance biopsies and decrease the rate of "progression" on late (third and further) surveillance biopsies compared to Transrectal Ultrasound-guided biopsies. 2. Quality of life (QoL) will be similar in patients undergoing MRI Ultrasound or MRI-guided and Transrectal Ultrasound-guided biopsies. 3. Biomarker expression levels will correlate with biopsy progression.

Key facts

Study ID

NCT01838265

Run by

University of Miami

People needed

0

Starts

2012-08-01

Last updated by the study team

2014-12-08

Who can join

Age: 35 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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