Prostate CancerMGMNCT01838265
Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management
An observational study of Prostate Cancer and Prostate Adenocarcinoma, run by University of Miami at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 35 to 75 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma
- What is being tested?
- Transrectal Ultrasound-Guided Biopsy, MRI Ultrasound Biopsy and Expanded Prostate Cancer index Composite Questionnaire
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Two-Arm Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management: The MGM Trial
- 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.
- Quality of life (QoL) will be similar in patients undergoing MRI Ultrasound or MRI-guided and Transrectal Ultrasound-guided biopsies.
- Biomarker expression levels will correlate with biopsy progression.
Read the 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.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Being tested
- Transrectal Ultrasound-Guided Biopsy, MRI Ultrasound Biopsy, Expanded Prostate Cancer index Composite Questionnaire, Short-Form 12 of Health Related Quality of Life Questionnaire, Memorial Anxiety Scale for Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transrectal Ultrasound-Guided BiopsyProcedure or surgery
Also called TRUS
Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
MRI Ultrasound BiopsyProcedure or surgery
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 QuestionnaireBehavioural
Also called EPIC
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 QuestionnaireBehavioural
Also called SF-12, SF-12 HRQOL
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Memorial Anxiety Scale for Prostate CancerBehavioural
Also called MAX-PC
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Plasma/Serum Sample for biomarkersProcedure or surgery
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 BiomarkersProcedure or surgery
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 CreatinineProcedure or surgery
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 PSAProcedure or surgery
Also called PSA test
Blood test for Serum PSA obtained at Baseline, at every 6 months up to 36 months from initial biopsy.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 | |
| 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) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 42 months
Secondary outcomes (2)
Expression Levels of Biomarkers from biopsies collected with MRI-us Biopsy vs Standard Ultrasound Biopsy
Measured: 42 months
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.
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startAug 2012
- Primary completionAug 2018 (estimated)
Why it stopped: Unlikely to Accrue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanoj Punnen, University of Miami
- Investigators
- Dipen Parekh, MD, Principal investigator, University of MiamiAlan Pollack, MD, Principal investigator, University of MiamiSanoj Punnen, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838265
- Sponsor's protocol ID
- 20120698
- Acronym
- MGM
- Status last verified
- Dec 2014
- First submitted
- 18 Apr 2013
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Two-Arm Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management: The MGM Trial
- ClinicalTrials.gov ID
- NCT01838265
- Acronym / sponsor ID
- MGM / 20120698
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unlikely to Accrue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2018 (estimated)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- Quality of life (QoL) will be similar in patients undergoing MRI Ultrasound or MRI-guided and Transrectal Ultrasound-guided biopsies.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AS: Active Surveillance Alone | – | 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 PSAActive 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 | – | 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 PSAMRI-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) |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transrectal Ultrasound-Guided BiopsyAlso: TRUSActive Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies). | Procedure or surgery | AS: Active Surveillance Alone |
| MRI Ultrasound BiopsyMRI-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 or surgery | MRI-AS: MRI+ Active Surveillance |
| Expanded Prostate Cancer index Composite QuestionnaireAlso: EPICQuality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy | Behavioural | AS: Active Surveillance Alone, MRI-AS: MRI+ Active Surveillance |
| Short-Form 12 of Health Related Quality of Life QuestionnaireAlso: SF-12, SF-12 HRQOLQuality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy | Behavioural | AS: Active Surveillance Alone, MRI-AS: MRI+ Active Surveillance |
| Memorial Anxiety Scale for Prostate CancerAlso: MAX-PCQuality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy | Behavioural | AS: Active Surveillance Alone, MRI-AS: MRI+ Active Surveillance |
| Plasma/Serum Sample for biomarkersPlasma/Serum Sample for biomarkers obtained at Baseline, and at 12, 24 and 36 months after initial biopsy for correlative studies (CTC, fcDNA, SNPs) | Procedure or surgery | AS: Active Surveillance Alone, MRI-AS: MRI+ Active Surveillance |
| Urine Sample for BiomarkersUrine Sample for biomarkers obtained at Baseline, and at 12, 24, and 36 months for correlative studies (hypermethylated DNA) | Procedure or surgery | AS: Active Surveillance Alone, MRI-AS: MRI+ Active Surveillance |
| Blood Tests for Blood Urea Nitrogen and CreatinineBlood 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 or surgery | AS: Active Surveillance Alone, MRI-AS: MRI+ Active Surveillance |
| Blood Test for Serum PSAAlso: PSA testBlood test for Serum PSA obtained at Baseline, at every 6 months up to 36 months from initial biopsy. | Procedure or surgery | AS: Active Surveillance Alone, MRI-AS: MRI+ Active Surveillance |
Primary outcome
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.
2 secondary outcomes
Expression Levels of Biomarkers from biopsies collected with MRI-us Biopsy vs Standard Ultrasound Biopsy
Time frame: 42 months
Effect of MRI Monitoring on Health-Related Quality of Life
Time frame: 42 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dipen Parekh, MD principal investigator
University of Miami
Alan Pollack, MD principal investigator
University of Miami
Sanoj Punnen, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostate Adenocarcinoma, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Progression in Subjects undergoing MRIus Biopsy vs Standard Ultrasound biopsy (time frame: 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.