Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management
NCT ID: NCT01838265
Last Updated: 2014-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2012-08-31
Brief Summary
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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.
Detailed Description
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* Arm I: Active Surveillance Alone (AS). TRUS guided biopsies at start (within 6 months of enrollment) and at yearly intervals thereafter up to 36 months after the initial biopsy (maximum four biopsies).
* Arm II: MRI-Managed Active Surveillance (MRI-AS). MRIus or MRI-guided biopsies at start (within 6 months of enrollment) and at yearly intervals thereafter up to 36 months after the initial biopsy (maximum four biopsies).
Patients will also complete Quality of Life (QoL) assessments to provide unique data on the effects of MRI monitoring for patients undergoing active surveillance on QOL. The investigators have selected a group of measures that have been used extensively in prostate cancer populations.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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AS: Active Surveillance Alone
Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
Transrectal Ultrasound-Guided Biopsy
Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
Expanded Prostate Cancer index Composite Questionnaire
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Short-Form 12 of Health Related Quality of Life Questionnaire
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Memorial Anxiety Scale for Prostate Cancer
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Plasma/Serum Sample for biomarkers
Plasma/Serum Sample for biomarkers obtained at Baseline, and at 12, 24 and 36 months after initial biopsy for correlative studies (CTC, fcDNA, SNPs)
Urine Sample for Biomarkers
Urine Sample for biomarkers obtained at Baseline, and at 12, 24, and 36 months for correlative studies (hypermethylated DNA)
Blood Tests for Blood Urea Nitrogen and Creatinine
Blood Tests for Blood Urea Nitrogen (BUN) and Creatinine obtained at 0 - 6 months, and at 12, 24, and 36 months from initial biopsy. This is optional, subject may refuse
Blood Test for Serum PSA
Blood test for Serum PSA obtained at Baseline, at every 6 months up to 36 months from initial biopsy.
MRI-AS: MRI+ Active Surveillance
MRI-Managed Active Surveillance (MRI-AS). MRI Ultrasound or MRI-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies)
MRI Ultrasound Biopsy
MRI-Managed Active Surveillance (MRI-AS). MRI Ultrasound or MRI-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies)
Expanded Prostate Cancer index Composite Questionnaire
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Short-Form 12 of Health Related Quality of Life Questionnaire
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Memorial Anxiety Scale for Prostate Cancer
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Plasma/Serum Sample for biomarkers
Plasma/Serum Sample for biomarkers obtained at Baseline, and at 12, 24 and 36 months after initial biopsy for correlative studies (CTC, fcDNA, SNPs)
Urine Sample for Biomarkers
Urine Sample for biomarkers obtained at Baseline, and at 12, 24, and 36 months for correlative studies (hypermethylated DNA)
Blood Tests for Blood Urea Nitrogen and Creatinine
Blood Tests for Blood Urea Nitrogen (BUN) and Creatinine obtained at 0 - 6 months, and at 12, 24, and 36 months from initial biopsy. This is optional, subject may refuse
Blood Test for Serum PSA
Blood test for Serum PSA obtained at Baseline, at every 6 months up to 36 months from initial biopsy.
Interventions
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Transrectal Ultrasound-Guided Biopsy
Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
MRI Ultrasound Biopsy
MRI-Managed Active Surveillance (MRI-AS). MRI Ultrasound or MRI-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies)
Expanded Prostate Cancer index Composite Questionnaire
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Short-Form 12 of Health Related Quality of Life Questionnaire
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Memorial Anxiety Scale for Prostate Cancer
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Plasma/Serum Sample for biomarkers
Plasma/Serum Sample for biomarkers obtained at Baseline, and at 12, 24 and 36 months after initial biopsy for correlative studies (CTC, fcDNA, SNPs)
Urine Sample for Biomarkers
Urine Sample for biomarkers obtained at Baseline, and at 12, 24, and 36 months for correlative studies (hypermethylated DNA)
Blood Tests for Blood Urea Nitrogen and Creatinine
Blood Tests for Blood Urea Nitrogen (BUN) and Creatinine obtained at 0 - 6 months, and at 12, 24, and 36 months from initial biopsy. This is optional, subject may refuse
Blood Test for Serum PSA
Blood test for Serum PSA obtained at Baseline, at every 6 months up to 36 months from initial biopsy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
35 Years
75 Years
MALE
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Sanoj Punnen
Assistant Professor
Principal Investigators
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Dipen Parekh, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Alan Pollack, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Sanoj Punnen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Other Identifiers
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20120698
Identifier Type: -
Identifier Source: org_study_id