N/A
N=208
MRI Based Active Selection for Treatment Trial
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02242773 ↗Enrolled (actual)
208
Serious AEs
2.4%
Results posted
Jul 2025
Primary outcome: Primary: Rate of Disease Progression Within the First Two Surveillance Biopsies — 36.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Multi-Parametric MRI (Device); MRI-Guided Biopsy (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Male
- Sponsor
- University of Miami
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Disease Progression Within the First Two Surveillance Biopsies |
36.1 | — |
| SECONDARY Time-to-Biochemical Recurrence (BCR) |
169 | — |
| SECONDARY Health-Related Quality of Life Scores: EPIC SF-12 |
31; 31 | — |
| SECONDARY Health-Related Quality of Life Scores: MAX-PC |
15; 12 | — |
| SECONDARY Discriminative Performance of NCCN Risk and Clinical Markers for Predicting Progression on Active Surveillance |
0.6717; 0.7398; 0.7168; 0.6858; 0.7412 | — |
Summary
The main purpose of this study is to determine if Magnetic Resonance Imaging (MRI), along with MRI targeted biopsy of suspicious lesions, is of value in detecting patients who would be likely to require treatment earlier.
Eligibility Criteria
Inclusion Criteria
- Biopsy confirmed adenocarcinoma of the prostate within 18 months prior to enrollment;
- Pre-enrollment prostate biopsy must consist of at least 8 cores;
- Biopsy reviewed by a University of Miami Pathologist;
- Serum Prostate-Specific Antigen (PSA) ≤ 20 ng/ml within 3 months of study enrollment;
- Age ≥ 35 and ≤ 85 years;
- Ability to understand and willingness to sign a written informed consent document;
- Patients must agree to undergo serial multiparametric MRI and MRI-guided biopsy;
- Patients must agree to fill out the longitudinal psychosocial questionnaires assessing health related quality of life.
Exclusion Criteria
- Greater than 4 cores positive, of any Gleason score, on the University of Miami (UM) review,
- Greater than 2 cores positive for Gleason 3+4 cancer,
- Gleason 4+3 or higher cancer in any single biopsy core.
- Extracapsular extension suspected on digital rectal exam with confirmation on MRI. Suspicion of extracapsular extension on MRI alone is not an exclusion for study enrollment.
- Subject is not a candidate for multiparametric MRI with contrast. Some reasons may include (but are not limited to): renal insufficiency, foreign body or pacemakers.
- No prior pelvic radiotherapy.
- No prior surgery to the prostate, other than transurethral procedures for benign prostatic hyperplasia (e.g., transurethral resection, green light laser treatment).
- No concurrent, active malignancy, other than non-metastatic skin cancer of any type, superficial bladder cancer, or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma) or <stage IV follicular lymphoma. If a prior malignancy is in remission for ≥ 3 years then the patient is eligible.
- Bilateral hip replacement.
Data sourced from ClinicalTrials.gov (NCT02242773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.