MRI Based Active Selection for Treatment Trial

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.

Sex

Male

Minimum age

35 Years

Maximum age

85 Years

Inclusion Criteria:

1. Biopsy confirmed adenocarcinoma of the prostate within 18 months prior to enrollment;
2. Pre-enrollment prostate biopsy must consist of at least 8 cores;
3. Biopsy reviewed by a University of Miami Pathologist;
4. Serum Prostate-Specific Antigen (PSA) ≤ 20 ng/ml within 3 months of study enrollment;
5. Age ≥ 35 and ≤ 85 years;
6. Ability to understand and willingness to sign a written informed consent document;
7. Patients must agree to undergo serial multiparametric MRI and MRI-guided biopsy;
8. Patients must agree to fill out the longitudinal psychosocial questionnaires assessing health related quality of life.

Exclusion Criteria:

1. Greater than 4 cores positive, of any Gleason score, on the University of Miami (UM) review,
2. Greater than 2 cores positive for Gleason 3+4 cancer,
3. Gleason 4+3 or higher cancer in any single biopsy core.
4. 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.
5. 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.
6. No prior pelvic radiotherapy.
7. No prior surgery to the prostate, other than transurethral procedures for benign prostatic hyperplasia (e.g., transurethral resection, green light laser treatment).
8. 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.
9. Bilateral hip replacement.

• DERIVEDSharifi SHH, Williams A, Ryan JT, Ajami T, Nativ OF, Han S, Reis IM, Soodana-Prakash N, Khandekar A, Swain S, Kryvenko ON, Stoyanova R, Pollack A, Castillo PR, Nahar B, Ritch CR, Kava B, Gonzalgo ML, Parekh DJ, Punnen S. Multiparametric MRI in prostate cancer active surveillance: results from the Miami Active Surveillance Trial (MAST) trial. BJU Int. 2026 Aug;138(2):276-284. doi: 10.1111/bju.70303. Epub 2026 May 6. PMID 42089595
• DERIVEDAngulo-Llanos L, Cortizas EM, Williams AD, Howell NB, Guerard T, Punnen S, Masterson TA, Kava B. Evaluating the correlation between biopsy frequency and reduced sexual function in prostate cancer patients under active surveillance: a prospective cohort study. J Sex Med. 2026 Apr 9;23(5):qdag100. doi: 10.1093/jsxmed/qdag100. PMID 41985042
• DERIVEDFreitas PFS, Khandekar A, Porto JG, Yu H, Williams AD, Avda Y, Malpani A, Ajami T, Mendiola DF, Soodana-Prakash N, Swain S, Gaston S, Kryvenko ON, Davicioni E, Alshalalfa M, Hao Y, Mahal B, Cortizas E, Szczotka Z, Guerard T, Kava B, Stoyanova R, Ritch CR, Nahar B, Gonzalgo ML, Pollack A, Parekh DJ, Punnen S. Can Genomic Classifiers in Biopsy Cores With Grade Group 1 Cancer Predict Higher-Grade Disease Elsewhere in the Prostate? Results From the Prospective Miami Active Surveillance Trial. J Urol. 2025 Oct;214(4):383-392. doi: 10.1097/JU.0000000000004652. Epub 2025 Jun 20. PMID 40540647
• DERIVEDKimbel IM, Wallaengen V, Zacharaki EI, Breto AL, Algohary A, Carbohn S, Gaston SM, Soodana-Prakash N, Freitas PFS, Kryvenko ON, Castillo P, Abramowitz MC, Ritch CR, Nahar B, Gonzalgo ML, Parekh DJ, Pollack A, Punnen S, Stoyanova R. HRS Improves Active Surveillance for Prostate Cancer by Timely Identification of Progression. Acad Radiol. 2025 Apr;32(4):2081-2089. doi: 10.1016/j.acra.2024.11.008. Epub 2024 Dec 17. PMID 39694787