Clinical trial NCT01838265: Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management
Official title: A Randomized Two-Arm Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management: The MGM Trial
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 0
Sex: MALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Rate of Progression in Subjects undergoing MRIus Biopsy vs Standard Ultrasound biopsy
timeFrame: 42 months
Secondary outcomes:
measure: Expression Levels of Biomarkers from biopsies collected with MRI-us Biopsy vs Standard Ultrasound Biopsy
timeFrame: 42 months
measure: Effect of MRI Monitoring on Health-Related Quality of Life
timeFrame: 42 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Dipen Parekh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Alan Pollack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Sanoj Punnen, MD
role: PRINCIPAL_INVESTIGATOR
References: