MRI Based Active Selection for Treatment Trial

NCT ID: NCT02242773

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-12
• Study Completion Date: 2024-05-22

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Surveillance

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.

Group Type: EXPERIMENTAL

Multi-Parametric MRI

Intervention Type: DEVICE

Multi-Parametric MRI

MRI-Guided Biopsy

Intervention Type: DEVICE

MRI-Guided Biopsy

Interventions

Multi-Parametric MRI

Multi-Parametric MRI

Intervention Type: DEVICE

MRI-Guided Biopsy

MRI-Guided Biopsy

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Sanoj Punnen, MD, MAS

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sanoj Punnen, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39694787 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01CA189295-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20140372

Identifier Type: -

Identifier Source: org_study_id