PD60-11 A PHASE 3 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF
            99M
            TC-MIP-1404 SPECT/CT IMAGING TO DETECT CLINICALLY SIGNIFICANT PROSTATE CANCER IN MEN WITH BIOPSY PROVEN LOW GRADE PROSTATE CANCER WHO ARE CANDIDATES FOR ACTIVE SURVEILLANCE (PROSPECT-AS)

Objective. To determine if primary circulating prostate cells (CPCs) are found in all men with prostate cancer.Methods and Patients. A prospective study, to analyze all men with an elevated PSA between 4.0 and 10.0 ng/mL undergoing initial biopsy. Primary CPCs were obtained by differential gel centrifugation and detected using standard immunocytochemistry using anti-PSA; positive samples underwent a second process with anti-P504S. A malignant primary CPC was defined as PSA (+) P504S (+) and a test positive if 1 cell/4 mL was detected. Biopsy results were registered as cancer/no-cancer, number of cores positive, and percent infiltration of the cores.Results. 328/1123 (29.2%) of the study population had prostate cancer diagnosed on initial biopsy, and 42/328 (12.8%) were negative for primary CPCs. CPC negative men were significantly older, and had lower PSA levels, lower Gleason scores, and fewer positive cores and with infiltration by the cancer. 38/42 (91%) of CPC negative men complied with the criteria for active surveillance in comparison with 34/286 (12%) of CPC positive men.Conclusions. Using primary CPC detection as a sequential test to select men with an elevated PSA for biopsy, the risk of missing clinically significant prostate cancer is minimal when the patient is primary CPC negative; less than 0.5% of all primary CPC negative men had a clinically significant prostate cancer.

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Comparison of conventional transrectal ultrasound, magnetic resonance imaging, and micro-ultrasound for visualizing prostate cancer in an active surveillance population: A feasibility study

Canadian Urological Association Journal ◽

10.5489/cuaj.5361 ◽

2018 ◽

Vol 13 (3) ◽

Cited By ~ 4

Author(s):

Gregg Eure ◽

Daryl Fanney ◽

Jefferson Lin ◽

Brian Wodlinger ◽

Sangeet Ghai

Keyword(s):

Magnetic Resonance Imaging ◽

Prostate Cancer ◽

Magnetic Resonance ◽

Real Time ◽

Active Surveillance ◽

Low Grade ◽

Resonance Imaging ◽

Biopsy Procedure ◽

Conventional Ultrasound ◽

Clinically Significant

Introduction: Active surveillance monitoring of prostate cancer is unique in that most patients have low-grade disease that is not well-visualized by any common imaging technique. High-resolution (29 MHz) micro-ultrasound is a new, real-time modality that has been demonstrated to be sensitive to significant prostate cancer and effective for biopsy targeting. This study compares micro-ultrasound imaging with magnetic resonance imaging (MRI) and conventional ultrasound for visualizing prostate cancer in active surveillance. Methods: Nine patients on active surveillance were imaged with multiparametric (mp) MRI prior to biopsy. During the biopsy procedure, imaging and target identification was first performed using conventional ultrasound, then using micro-ultrasound. The mpMRI report was then unblinded and used to determine cognitive fusion targets. Using micro-ultrasound, biopsy samples were taken from targets in each modality, plus 12 systematic samples. Results: mpMRI and micro-ultrasound both demonstrated superior sensitivity to Gleason sum 7 or higher cancer compared to conventional ultrasound (p=0.02 McNemar’s test). Micro-ultrasound detected 89% of clinically significant cancer, compared to 56% for mpMRI. Conclusions: Micro-ultrasound may provide similar sensitivity to clinically significant prostate cancer as mpMRI and visualize all significant mpMRI targets. Unlike mpMRI, micro-ultrasound is performed in the office, in real-time during the biopsy procedure, and so is expected to maintain the cost-effectiveness of conventional ultrasound. Larger studies are needed before these results may be applied in a clinical setting.

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Use of multiparametric MRI of prostate in active surveillance cohort of patients with localized prostate cancer in large urology group setting.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.7_suppl.129 ◽

2015 ◽

Vol 33 (7_suppl) ◽

pp. 129-129

Author(s):

Richard Kronhaus ◽

Dimitios Telonis ◽

Christopher Michael Pieczonka ◽

Howard Williams ◽

David Albala ◽

...

Keyword(s):

Prostate Cancer ◽

Sensitivity And Specificity ◽

Active Surveillance ◽

Predictive Value ◽

Small Sample Size ◽

Small Sample ◽

Definitive Treatment ◽

Low Grade ◽

Group Setting ◽

Clinically Significant

129 Background: The aim of this study was to determine the feasibility of using mpMRI to monitor/reclassify patients with low grade Prostate Cancer (PCa) undergoing Active Surveillance in a large urology practice. Methods: This is a retrospective study reviewing the records of 28 total patients following active surveillance (AS) protocol. All patients have been diagnosed with biopsy proven prostate cancer (PCa) and have undergone at least one mpMRI as a means of surveillance. The median total PSA of the group at time of diagnosis was 5.93 ng/ml and the mean age of the group was 64 years old. Between the 28 patients, 38 mpMRI tests were conducted, consisting of T2-weighted, diffusion weighted, and dynamic contrast enhanced MRI. Targeted ‘cognitive’ TRUS-MRI guided biopsy was used to locate progression of the PCa and help to determine whether a patient should stay on AS versus choosing more aggressive, definitive treatment. Confirmatory random biopsy was also used to determine overall sensitivity and specificity of the mpMRI conducted for suspicious regions of interest (ROI). Results: The sensitivity and specificity for the group was 65% and 92% respectively. The positive predictive value for the group was 94% while the negative predictive value was 55%. mpMRI was able to detect all clinically significant cancers except in one case. It did not detect some small size lesions (≤5.5mm) of Gleason score 6 that did not have a relevant clinical value. In five of the 28 cases (18%), patients fit the criteria for reclassification (Gleason ≥7, ≥ 3 new positive cores) out of the AS group. Four of these five patients exhibited clear progression of PCa on mpMRI and elected for more aggressive definitive treatment . The progression of cancer in the fifth patient was not seen on mpMRI but only after biopsy. This patient elected to stay in AS because of his advanced age. Conclusions: Despite the limitation of small sample size, mpMRI can be used as an effective diagnostic tool in the AS cohort of a community practice. It can facilitate early detection and progression of suspicious lesion(s) towards clinically significant PCa, thus triggering the start of more aggressive treatment.

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A longitudinal study of patients undergoing active surveillance for low grade prostate cancer diagnosed at Transperineal Template Prostate Mapping

European Urology Supplements ◽

10.1016/s1569-9056(19)30454-3 ◽

2019 ◽

Vol 18 (1) ◽

pp. e615

Author(s):

M. Kailavasan ◽

T.J. Walton ◽

P. Ravindra ◽

S. Trecarten ◽

J. Voss ◽

...

Keyword(s):

Prostate Cancer ◽

Longitudinal Study ◽

Active Surveillance ◽

Low Grade

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Active Surveillance Strategies for Low-Grade Prostate Cancer: Comparative Benefits and Cost-effectiveness

Radiology ◽

10.1148/radiol.2021204321 ◽

2021 ◽

pp. 204321

Author(s):

Stella K. Kang ◽

Rahul D. Mali ◽

Vinay Prabhu ◽

Bart S. Ferket ◽

Stacy Loeb

Keyword(s):

Prostate Cancer ◽

Cost Effectiveness ◽

Active Surveillance ◽

Low Grade

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Overdiagnosis and Overtreatment of Prostate Cancer

American Society of Clinical Oncology Educational Book ◽

10.14694/edbook_am.2012.32.98 ◽

2012 ◽

pp. e35-e39 ◽

Cited By ~ 4

Author(s):

Ian M. Thompson

Keyword(s):

Prostate Cancer ◽

Active Surveillance ◽

Specific Antigen ◽

The United States ◽

Assessment Tools ◽

Low Grade ◽

High Grade ◽

Surveillance Strategy ◽

Psa Testing ◽

Prostate Cancer Prevention

Overview: Prostate cancer is a ubiquitous disease, affecting as many as two-thirds of men in their 60s. Through widespread prostate-specific antigen (PSA) testing, increasing rates of prostate biopsy, and increased sampling of the prostate, a larger fraction of low-grade, low-volume tumors have been detected, consistent with tumors often found at autopsy. These tumors have historically been treated in a manner similar to that used for higher-grade tumors but, more recently, it has become evident that with a plan of active surveillance that reserves treatment for only those patients whose tumors show evidence of progression, very high disease-specific survival can be achieved. Unfortunately, the frequency of recommendation of an active surveillance strategy in the United States is low. An alternative strategy to improve prostate cancer detection is through selected biopsy of those men who are at greater risk of harboring high-grade, potentially lethal cancer. This strategy is currently possible through the use of risk assessment tools such as the Prostate Cancer Prevention Trial Risk Calculator ( www.prostate.cancer.risk.calculator.com ) as well as others. These tools can predict with considerable accuracy a man's risk of low-grade and high-grade cancer, allowing informed decision making for the patient with a goal of detection of high-risk disease. Ultimately, other biomarkers including PCA3, TMPRSS2:ERG, and [-2]proPSA will likely aid in discriminating these two types of cancer before biopsy.

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Epigenetic Signature: A New Player as Predictor of Clinically Significant Prostate Cancer (PCa) in Patients on Active Surveillance (AS)

International Journal of Molecular Sciences ◽

10.3390/ijms18061146 ◽

2017 ◽

Vol 18 (6) ◽

pp. 1146 ◽

Cited By ~ 5

Author(s):

Matteo Ferro ◽

Paola Ungaro ◽

Amelia Cimmino ◽

Giuseppe Lucarelli ◽

Gian Busetto ◽

...

Keyword(s):

Prostate Cancer ◽

Active Surveillance ◽

Clinically Significant

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MRI-US fusion targeted biopsy results in patients without history of prostate biopsy.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.2_suppl.150 ◽

2016 ◽

Vol 34 (2_suppl) ◽

pp. 150-150

Author(s):

Cayce Nawaf ◽

James Rosoff ◽

Jeffrey Weinreb ◽

Amanda Lu ◽

Angelique Levi ◽

...

Keyword(s):

Prostate Cancer ◽

Prostate Biopsy ◽

Low Grade ◽

Test Results ◽

Targeted Biopsy ◽

Chi Square ◽

Detection Rates ◽

History Of ◽

Clinically Significant ◽

Mapping Biopsy

150 Background: Results from 12-core template mapping biopsy (Mbx) and concurrent MRI-US fusion targeted biopsy (Tbx) were compared in 118 men without prior biopsy. Methods: Between 12/2012 and 06/2015, 374 men with an indication for prostate biopsy presented to our institution and underwent pre-biopsy mpMRI followed by 12-core standard trans-rectal mapping biopsy (Mbx) and MRI-Ultrasound fusion targeted biopsy (Tbx) of lesions identified on mpMRI. The combination of Mbx and Tbx, when both occurred, constitutes a fusion biopsy (Fbx). Men who underwent both Mbx with or without Tbx using the Artemis/Pro-Fuse system with no previous biopsy were included. Patients without a lesion on MRI underwent Mbx only. Maximum Gleason scores (GS) was assigned on a per patient basis with Mbx GS available for all patients in the cohort and Tbx GS available only for patients with a lesion visible on MP-MRI. Clinically significant (CS) was defined as GS ≥3+4. GS per patient was compared by chi-square and McNemar’s test. Results: 118 men met inclusion criteria (mean age=64.9, mean PSA=11.5). Prostate cancer was detected in 64 (54%) Fbx cases. Cancer detection rates for Mbx and Tbx were 54% and 57%, respectively. In patients where Fbx identified CS cancer, Tbx was more likely to have identified the cancer than Mbx (96% vs 72%; p < 0.001). Fewer GS 6 cancers were detected by Tbx (n=7) than by Mbx (n=25), and Tbx alone would have prevented the detection of 21 (18%) cases of GS 6 disease. Conversely, more GS≥ 7 (50% of men) was detected on Tbx than on Mbx (33% of men). In total, there were 16 patients (13.5%) that were missed or understaged by Tbx, but only 4 of these patients (3%) were GS≥ 7. In contrast, there were 19 (16%) patients that were missed or understaged by Mbx, but 17 (14%) of these 19 patients harbored GS≥ 7 disease. Conclusions: In biopsy-naive men who are suspected to have prostate cancer, Tbx provides improved detection of CS prostate cancer compared with Mbx while decreasing the detection of low-grade disease. Tbx alone in biopsy-naive men should be considered if missing 3% of CS disease is acceptable. [Table: see text]

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Expanded criteria in men on active surveillance monitored by MRI-TRUS fusion biopsy.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.2_suppl.115 ◽

2016 ◽

Vol 34 (2_suppl) ◽

pp. 115-115

Author(s):

Thomas P Frye ◽

Steven F. Abboud ◽

Richard Ho ◽

Michele Fascelli ◽

Raju Chelluri ◽

...

Keyword(s):

Prostate Cancer ◽

Active Surveillance ◽

Progression Free Survival ◽

Risk Groups ◽

Low Risk ◽

Intermediate Risk ◽

Guided Biopsy ◽

Risk Prostate Cancer ◽

Expanded Criteria ◽

Clinically Significant

115 Background: Active surveillance (AS) is an established option for men with prostate cancer. Studies have shown that multiparametric-MRI along with MRI-TRUS fusion-guided biopsy (FB) may better assess risk in patients eligible for AS, compared to 12-core biopsy, due to improved detection of clinically significant cancers. The objective is to evaluate the performance of expanded criteria eligibility in men on AS being monitored with MRI-TRUS guided biopsy. Methods: Men on AS were included if they had mp-MRI and pathology data for 2 or more FB sessions. FB procedures consisted of targeted biopsies and random 12 core biopsies. Men participated in AS with low and intermediate risk prostate cancer, Gleason score ≤ 3+4=7 with no restriction on percent core involvement or number of cores positive. Progression was defined by patients with initial Gleason 3+3=6 to any Gleason 4, and Gleason 3+4=7 disease progressing to a primary Gleason 4 or higher. Results: 124 men on AS met study criteria. Low risk men had a mean age of 61.3 years versus intermediate risk men with a mean age of 65.5 years (p=0.0062). Mean PSA levels of the low and intermediate risk groups were 5.8 and 5.76 ng/ml (p=0.95), respectively. The mean length of follow-up was 22.56 months (range: 3.6 – 74.4 mo). Rates of pathologic progression in the intermediate and low risk patients were, 38.5% vs. 28.5% (p=0.33). Intermediate risk men had a mean progression-free survival (PFS) of 2.8 years compared to low risk men of 3.9 years (p=0.27). Patients were stratified according to established AS criteria (Epstein, Toronto, PRIAS) and rates of progression are summarized in the Table. 69% of patients met Epstein criteria for AS of which 29.4% (20/68) progressed compared to 28.5% for the low risk cohort overall. Conclusions: Men in our cohort who met strict criteria for AS had the same rate of progression as the entire expaned criteria low risk cohort, 29.4% vs 28.5%, respectively. Our data suggests that with accurate initial Gleason classification other AS criteria such as percent core or number of cores positive have no added benefit in predicting which men may have reclassification or progression of disease. [Table: see text]

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