Trial Outcomes & Findings for MRI Based Active Selection for Treatment Trial (NCT NCT02242773)

Last Updated: 2025-07-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

208 participants

Primary outcome timeframe

24 months

Results posted on

2025-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	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. Multi-Parametric MRI: Multi-Parametric MRI MRI-Guided Biopsy: MRI-Guided Biopsy
Overall Study STARTED	208
Overall Study COMPLETED	208
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MRI Based Active Selection for Treatment Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Surveillance n=208 Participants 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. Multi-Parametric MRI: Multi-Parametric MRI MRI-Guided Biopsy: MRI-Guided Biopsy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	127 Participants n=5 Participants
Age, Categorical >=65 years	81 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	208 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	84 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	119 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants
Race (NIH/OMB) White	182 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	208 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Outcome measures

Outcome measures
Measure	Active Surveillance n=208 Participants 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. Multi-Parametric MRI: Multi-Parametric MRI MRI-Guided Biopsy: MRI-Guided Biopsy
Rate of Disease Progression Within the First Two Surveillance Biopsies	36.1 percentage of participants

SECONDARY outcome

Timeframe: Up to 36 months

Population: Participants who underwent primary therapy for prostate cancer.

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.

Outcome measures

Outcome measures
Measure	Active Surveillance n=82 Participants 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. Multi-Parametric MRI: Multi-Parametric MRI MRI-Guided Biopsy: MRI-Guided Biopsy
Time-to-Biochemical Recurrence (BCR)	169 days Interval 143.0 to 175.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Active Surveillance n=208 Participants 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. Multi-Parametric MRI: Multi-Parametric MRI MRI-Guided Biopsy: MRI-Guided Biopsy
Health-Related Quality of Life Scores: EPIC SF-12 Median score at Baseline	31 score on a scale Interval 29.0 to 32.0
Health-Related Quality of Life Scores: EPIC SF-12 Median score at Last Follow-up	31 score on a scale Interval 29.0 to 33.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Active Surveillance n=208 Participants 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. Multi-Parametric MRI: Multi-Parametric MRI MRI-Guided Biopsy: MRI-Guided Biopsy
Health-Related Quality of Life Scores: MAX-PC Median Score at Baseline	15 score on a scale Interval 11.0 to 22.0
Health-Related Quality of Life Scores: MAX-PC Median Score at Last Follow-up	12 score on a scale Interval 9.0 to 19.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Active Surveillance n=208 Participants 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. Multi-Parametric MRI: Multi-Parametric MRI MRI-Guided Biopsy: MRI-Guided Biopsy
Discriminative Performance of NCCN Risk and Clinical Markers for Predicting Progression on Active Surveillance NCCN Risk	0.6717 probability
Discriminative Performance of NCCN Risk and Clinical Markers for Predicting Progression on Active Surveillance NCCN + MRI	0.7398 probability
Discriminative Performance of NCCN Risk and Clinical Markers for Predicting Progression on Active Surveillance NCCN + PSA Density (PSAd)	0.7168 probability
Discriminative Performance of NCCN Risk and Clinical Markers for Predicting Progression on Active Surveillance NCCN + Decipher Score	0.6858 probability
Discriminative Performance of NCCN Risk and Clinical Markers for Predicting Progression on Active Surveillance NCCN + 4k Score	0.7412 probability

Adverse Events

Active Surveillance

Serious events: 5 serious events

Other events: 8 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Active Surveillance n=208 participants at risk 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. Multi-Parametric MRI: Multi-Parametric MRI MRI-Guided Biopsy: MRI-Guided Biopsy
Vascular disorders Hypertension	0.48% 1/208 • Number of events 1 • Six years
Infections and infestations Sepsis	1.9% 4/208 • Number of events 4 • Six years
Infections and infestations Urinary Tract Infection	0.96% 2/208 • Number of events 2 • Six years

Other adverse events

Other adverse events
Measure	Active Surveillance n=208 participants at risk 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. Multi-Parametric MRI: Multi-Parametric MRI MRI-Guided Biopsy: MRI-Guided Biopsy
Cardiac disorders Acute coronary syndrome	0.48% 1/208 • Number of events 1 • Six years
Musculoskeletal and connective tissue disorders Back pain	0.48% 1/208 • Number of events 1 • Six years
General disorders Chills	0.48% 1/208 • Number of events 1 • Six years
Renal and urinary disorders Cystitis noninfective	0.96% 2/208 • Number of events 2 • Six years
Metabolism and nutrition disorders Dehydration	0.48% 1/208 • Number of events 1 • Six years
Nervous system disorders Dizziness	0.48% 1/208 • Number of events 1 • Six years
Reproductive system and breast disorders Erectile dysfunction	0.48% 1/208 • Number of events 1 • Six years
General disorders Fever	0.48% 1/208 • Number of events 1 • Six years
Nervous system disorders Headache	0.48% 1/208 • Number of events 2 • Six years
Renal and urinary disorders Hematuria	0.48% 1/208 • Number of events 2 • Six years
Metabolism and nutrition disorders Hypokalemia	0.48% 1/208 • Number of events 1 • Six years
General disorders Non-cardiac chest pain	0.48% 1/208 • Number of events 2 • Six years
Musculoskeletal and connective tissue disorders Pain in extremity	0.48% 1/208 • Number of events 1 • Six years
Reproductive system and breast disorders Testicular disorder	0.48% 1/208 • Number of events 1 • Six years
Renal and urinary disorders Urinary retention	1.4% 3/208 • Number of events 3 • Six years
Infections and infestations Urinary tract infection	0.48% 1/208 • Number of events 1 • Six years

Additional Information

Sanoj Punnen, MD

University of Miami

Phone: +1 (305) 2436596

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place