MRI Based Active Selection for Treatment Trial

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Device: Multi-Parametric MRI; Device: MRI-Guided Biopsy

• Registration Number: NCT02242773
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-13
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-17
• Study Start: 2014-11-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 207

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Surveillance	MRI-Guided Biopsy	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.
Active Surveillance	Multi-Parametric MRI	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.

Primary Outcome Measures

Name	Time	Method
Rate of Disease Progression within the first two surveillance biopsies	24 months	To determine if multiparametric MRI and MRI-US fusion biopsies increase the rate of progression (conversion to treatment) within the first two non-diagnostic biopsies after undergoing active surveillance as compared to historical cohorts using standard ultrasound guided biopsies.; 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.

Secondary Outcome Measures

Name	Time	Method
Area under Receiver Operating Characteristic (ROC) curve	Up to 36 months	The investigators will assess the incremental benefit of mpMRI, genomic risk test, and molecular markers compared to baseline NCCN risk classification for predicting progression on active surveillance. Area under the receiver operating characteristic Curve (ROC) curve will be used to evaluate the performance of NCCN risk and other variables (MRI, genomic testing, and molecular markers) for predicting progression on surveillance. Participants will be categorized at baseline by NCCN risk class ranging from very low risk to intermediate risk; and into those who progressed while on the trial.
Health-Related Quality of Life Scores: EPIC SF-12	Up to 36 months	Health-Related Quality of Life will be assessed using scores from validated questionnaires. The Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) will be used to evaluate patient function and satisfaction after prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
Health-Related Quality of Life Scores: MAX-PC	Up to 36 months	Health-Related Quality of Life will be assessed using scores from validated questionnaires. The Memorial Anxiety Scale for Prostate Cancer (MAX-PC) will be used to measure anxiety from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.
Time-to-Biochemical Recurrence	Up to 36 months	The investigators will use recurrence after primary therapy to identify whether earlier identification of progression with MRI and MRI-US fusion biopsy will portend less recurrence compared to historical patients undergoing delayed primary surgery or radiation after initial surveillance. Biochemical recurrence (BCR) is defined as PSA of 0.2 or higher on two or more separate measures after surgery or an increase of nadir + 2ng/ml or more after radiation. Time-to-BCR is defined as duration between date of treatment and date of BCR if BCR occurs. The investigators will follow participants who have progressed and gone on to treatment.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States