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

Withdrawn

• Conditions: Prostate Cancer; Prostate Adenocarcinoma
• Interventions: Procedure: MRI Ultrasound Biopsy; Procedure: Transrectal Ultrasound-Guided Biopsy; Behavioral: Expanded Prostate Cancer index Composite Questionnaire; Behavioral: Short-Form 12 of Health Related Quality of Life Questionnaire; Behavioral: Memorial Anxiety Scale for Prostate Cancer; Procedure: Plasma/Serum Sample for biomarkers; Procedure: Urine Sample for Biomarkers; Procedure: Blood Tests for Blood Urea Nitrogen and Creatinine; Procedure: Blood Test for Serum PSA

• Registration Number: NCT01838265
• Lead Sponsor: University of Miami

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) 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.

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 number of positive cores in the diagnostic biopsy (1 vs 2):

* 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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-04-18
• Study First Posted: 2013-04-24
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-08
• Primary Completion: 2018-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MRI-AS: MRI+ Active Surveillance	Blood Test for Serum PSA	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)
AS: Active Surveillance Alone	Expanded Prostate Cancer index Composite Questionnaire	Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
MRI-AS: MRI+ Active Surveillance	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)
AS: Active Surveillance Alone	Memorial Anxiety Scale for Prostate Cancer	Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
MRI-AS: MRI+ Active Surveillance	Blood Tests for Blood Urea Nitrogen and Creatinine	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-AS: MRI+ Active Surveillance	Expanded Prostate Cancer index Composite Questionnaire	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-AS: MRI+ Active Surveillance	Plasma/Serum Sample for biomarkers	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)
AS: Active Surveillance Alone	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).
AS: Active Surveillance Alone	Short-Form 12 of Health Related Quality of Life Questionnaire	Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
AS: Active Surveillance Alone	Urine Sample for Biomarkers	Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
AS: Active Surveillance Alone	Blood Tests for Blood Urea Nitrogen and Creatinine	Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
MRI-AS: MRI+ Active Surveillance	Memorial Anxiety Scale for Prostate Cancer	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-AS: MRI+ Active Surveillance	Urine Sample for Biomarkers	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)
AS: Active Surveillance Alone	Plasma/Serum Sample for biomarkers	Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
AS: Active Surveillance Alone	Blood Test for Serum PSA	Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
MRI-AS: MRI+ Active Surveillance	Short-Form 12 of Health Related Quality of Life Questionnaire	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)

Primary Outcome Measures

Name	Time	Method
Rate of Progression in Subjects undergoing MRIus Biopsy vs Standard Ultrasound biopsy	42 months	To determine of multiparametric MRIus-guided biopsies increase the rate of progression on early (first two) biopsies in men undergoing active surveillance as compared with early detection using standard ultrasound biopsy.

Secondary Outcome Measures

Name	Time	Method
Expression Levels of Biomarkers from biopsies collected with MRI-us Biopsy vs Standard Ultrasound Biopsy	42 months
Effect of MRI Monitoring on Health-Related Quality of Life	42 months	To determine the effect of MRI monitoring on health-related quality of life (HRQOL), prostate cancer-specific anxiety QOL (ie general, PSA-testing \& recurrence anxiety, PC-Anxiety) and prostate cancer-specific QOL (ie sexual, urinary \& bowel function, PC-QOL), particularly as they relate to ethnically and socioeconomically diverse and disparate populations.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States