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

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ClinicalTrials.gov Identifier: NCT01838265
Recruitment Status : Withdrawn (Unlikely to Accrue)
First Posted : April 24, 2013
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Sanoj Punnen, 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.

Condition or disease Intervention/treatment
Prostate Cancer Prostate Adenocarcinoma Procedure: Transrectal Ultrasound-Guided Biopsy Procedure: MRI Ultrasound 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

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.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Randomized Two-Arm Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management: The MGM Trial
Study Start Date : August 2012
Estimated Primary Completion Date : August 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).
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).
Other Name: TRUS

Behavioral: Expanded Prostate Cancer index Composite Questionnaire
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Other Name: EPIC

Behavioral: 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
Other Names:
  • SF-12
  • SF-12 HRQOL

Behavioral: Memorial Anxiety Scale for Prostate Cancer
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Other Name: MAX-PC

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)

Procedure: Urine Sample for Biomarkers
Urine Sample for biomarkers obtained at Baseline, and at 12, 24, and 36 months for correlative studies (hypermethylated DNA)

Procedure: 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

Procedure: 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 Name: PSA test

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)
Procedure: 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
Other Name: EPIC

Behavioral: 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
Other Names:
  • SF-12
  • SF-12 HRQOL

Behavioral: Memorial Anxiety Scale for Prostate Cancer
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Other Name: MAX-PC

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)

Procedure: Urine Sample for Biomarkers
Urine Sample for biomarkers obtained at Baseline, and at 12, 24, and 36 months for correlative studies (hypermethylated DNA)

Procedure: 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

Procedure: 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 Name: PSA test




Primary Outcome Measures :
  1. Rate of Progression in Subjects undergoing MRIus Biopsy vs Standard Ultrasound biopsy [ Time Frame: 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 :
  1. Expression Levels of Biomarkers from biopsies collected with MRI-us Biopsy vs Standard Ultrasound Biopsy [ Time Frame: 42 months ]
  2. Effect of MRI Monitoring on Health-Related Quality of Life [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Biopsy tumor tissue, blood and urine samples for correlative studies (circulating tumor cells (CTC), free-circulating DNA (fcDNA) and single nucleotide polymorphisms (SNPs)


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Low risk male patients with early stage T1 - T2a prostate adenocarcinoma, based on a digital rectal exam palpation. Patients must also have less than three positive cores with < 50% of a single core; and Gleason score 3 + 3 = 6 or less.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838265


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Dipen Parekh, MD University of Miami
Principal Investigator: Alan Pollack, MD University of Miami
Principal Investigator: Sanoj Punnen, MD University of Miami

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Responsible Party: Sanoj Punnen, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01838265     History of Changes
Other Study ID Numbers: 20120698
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Genital Diseases, Male
Carcinoma