Clinical trial · Observational
Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management
A Randomized Two-Arm Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management: The MGM Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unlikely to Accrue
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Test for Serum PSA | Procedure | — | UNRESOLVED |
| Blood Tests for Blood Urea Nitrogen and Creatinine | Procedure | — | UNRESOLVED |
| Expanded Prostate Cancer index Composite Questionnaire | Behavioral | — | UNRESOLVED |
| Memorial Anxiety Scale for Prostate Cancer | Behavioral | — | UNRESOLVED |
| MRI Ultrasound Biopsy | Procedure | — | UNRESOLVED |
| Plasma/Serum Sample for biomarkers | Procedure | — | UNRESOLVED |
| Short-Form 12 of Health Related Quality of Life Questionnaire | Behavioral | — | UNRESOLVED |
| Transrectal Ultrasound-Guided Biopsy |
Design
Arms and outcomes
Arms (2)
- label
- AS: Active Surveillance Alone
- description
- Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
- interventionNames
- 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
- label
- MRI-AS: MRI+ Active Surveillance
- description
- 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)
- interventionNames
- Procedure: MRI Ultrasound Biopsy
- Behavioral: Expanded Prostate Cancer index Composite Questionnaire
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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