MRI Based Active Selection for Treatment Trial

Not Applicable

Completed

Conditions: Prostate Cancer

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 208

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of Disease Progression Within the First Two Surveillance Biopsies	24 months	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.

Secondary Outcome Measures

Name	Time	Method
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 (BCR)	Up to 36 months	Biochemical recurrence (BCR) is defined as prostate-specific antigen (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 in days between date of treatment and date of BCR, if BCR occurs. The investigators will follow participants who have progressed and gone on to treatment.
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 Short Form-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.
Discriminative Performance of NCCN Risk and Clinical Markers for Predicting Progression on Active Surveillance	Up to 36 months	The investigators will assess the incremental benefit of multiparametric MRI (mpMRI), genomic risk test, and molecular markers compared to baseline National Comprehensive Cancer Network (NCCN) risk classification for predicting progression on active surveillance. Area under the receiver operating characteristic Curve (ROC) curves produced from logistic regression modeling 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. Additionally, MRI results, PSA density, 4K score, and Decipher Score in combination with NCCN risk were analyzed to see their additive value on determining who will experience progression on active surveillance.