Prostate Adenocarcinoma, Prostate Cancer
Conditions
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.
Interventions
PROCEDURETransrectal 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).
PROCEDUREMRI 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)
BEHAVIORALExpanded Prostate Cancer index Composite Questionnaire
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
BEHAVIORALShort-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
BEHAVIORALMemorial Anxiety Scale for Prostate Cancer
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
PROCEDUREPlasma/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)
PROCEDUREUrine Sample for Biomarkers
Urine Sample for biomarkers obtained at Baseline, and at 12, 24, and 36 months for correlative studies (hypermethylated DNA)
PROCEDUREBlood 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
PROCEDUREBlood Test for Serum PSA
Blood test for Serum PSA obtained at Baseline, at every 6 months up to 36 months from initial biopsy.
Sponsors
University of Miami
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
35 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Progression in Subjects undergoing MRIus Biopsy vs Standard Ultrasound biopsy | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Outcome results
None listed