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

Prostate Cancer Clinical Trial

— MGM  

Official title:

A Randomized Two-Arm Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management: The MGM Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01838265
• Other study ID #: 20120698
• Status: Withdrawn
• Phase: N/A
• First received: April 18, 2013
• Last updated: December 5, 2014
• Start date: August 2012

Study information

• Verified date: December 2014
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• 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)

Behavioral:
• 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

Procedure:
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Progression in Subjects undergoing MRIus Biopsy vs Standard Ultrasound biopsy	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.	42 months	No
Secondary	Expression Levels of Biomarkers from biopsies collected with MRI-us Biopsy vs Standard Ultrasound Biopsy		42 months	No
Secondary	Effect of MRI Monitoring on Health-Related Quality of Life	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.	42 months	No