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Unlikely to Accrue
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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):
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transrectal Ultrasound-Guided Biopsy | Procedure | Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Expression Levels of Biomarkers from biopsies collected with MRI-us Biopsy vs Standard Ultrasound Biopsy | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dipen Parekh, MD | University of Miami | Principal Investigator |
| Alan Pollack, MD | University of Miami | Principal Investigator |
| Sanoj Punnen, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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Biopsy tumor tissue, blood and urine samples for correlative studies (circulating tumor cells (CTC), free-circulating DNA (fcDNA) and single nucleotide polymorphisms (SNPs)
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| MRI Ultrasound Biopsy | Procedure | 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 Questionnaire | Behavioral | Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy |
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| Short-Form 12 of Health Related Quality of Life Questionnaire | Behavioral | Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy |
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| Memorial Anxiety Scale for Prostate Cancer | Behavioral | Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy |
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| Plasma/Serum Sample for biomarkers | Procedure | Plasma/Serum Sample for biomarkers obtained at Baseline, and at 12, 24 and 36 months after initial biopsy for correlative studies (CTC, fcDNA, SNPs) |
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| Urine Sample for Biomarkers | Procedure | Urine Sample for biomarkers obtained at Baseline, and at 12, 24, and 36 months for correlative studies (hypermethylated DNA) |
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| Blood Tests for Blood Urea Nitrogen and Creatinine | Procedure | 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 |
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| Blood Test for Serum PSA | Procedure | Blood test for Serum PSA obtained at Baseline, at every 6 months up to 36 months from initial biopsy. |
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| 42 months |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D015415 | Biomarkers |
| D006403 | Hematologic Tests |
| D001806 | Blood Urea Nitrogen |
| D003404 | Creatinine |
| D017430 | Prostate-Specific Antigen |
| ID | Term |
|---|---|
| D001685 | Biological Factors |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D007677 | Kidney Function Tests |
| D003950 | Diagnostic Techniques, Urological |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007610 | Kallikreins |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D029584 | Prostatic Secretory Proteins |
| D029589 | Seminal Plasma Proteins |
| D000094664 | Seminal Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000951 | Antigens, Neoplasm |
| D000941 | Antigens |
| D014408 | Biomarkers, Tumor |
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