MRI Based Active Selection for Treatment Trial

NCT02242773 | Completed Results DMC FDA Device

• 2 other identifiers: 201403721R01CA189295-01
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Active Surveillance; MRI-Guided Biopsy; Multi-parametric MRI; MP-MRI

Outcome Measures

Primary Outcomes (1)

• Rate of Disease Progression Within the First Two Surveillance Biopsies

  The rate of disease progression among participants within the first two surveillance biopsies will be reported. Progression refers to a repeat surveillance biopsy indicating any one of the following: 1. More than 4 positive cores involving any grade of cancer, 2. At least two core with Gleason 3+4 cancer, 3. Any single core with Gleason 4+3 cancer or higher, 4. A Gleason 3+3 at diagnosis that is upgraded to Gleason 3+4, or 5. Undergoing treatment, regardless of histological progression.

  24 months

Secondary Outcomes (4)

• Time-to-Biochemical Recurrence (BCR)

  Up to 36 months

• Health-Related Quality of Life Scores: EPIC SF-12

  Up to 36 months

• Health-Related Quality of Life Scores: MAX-PC

  Up to 36 months

• Discriminative Performance of NCCN Risk and Clinical Markers for Predicting Progression on Active Surveillance

  Up to 36 months

Study Arms (1)

Active Surveillance

EXPERIMENTAL

Participants in this group will receive a Multi-Parametric Magnetic Resonance Imaging (MP-MRI) of the prostate/pelvis and MRI-guided prostate biopsy at baseline (0-3 months from enrollment) and at the 12th, 24th and 36th month follow up.

Device: Multi-Parametric MRI; Device: MRI-Guided Biopsy

Interventions

Multi-Parametric MRI DEVICE

Multi-Parametric MRI

Active Surveillance

MRI-Guided Biopsy DEVICE

MRI-Guided Biopsy

Active Surveillance

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Kimbel 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 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Sanoj Punnen, MD
• Organization: University of Miami

s.punnen@med.miami.edu

+1 (305) 2436596

Study Officials

• Sanoj Punnen, MD, MAS

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 13, 2014
• First Posted: September 17, 2014
• Study Start: November 12, 2014
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: July 11, 2025
• Results First Posted: July 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)