Effect of dutasteride on prostate cancer progression and cancer diagnosis on rebiopsy in the REDEEM active surveillance study.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 2-2 ◽  
Author(s):  
N. Fleshner ◽  
M. S. Lucia ◽  
K. Melich ◽  
I. M. Nandy ◽  
L. Black ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Gleason Score ◽  
Cancer Progression ◽  
Primary Endpoint ◽  
Expectant Management ◽  
Time To Progression ◽  
Clinical Progression ◽  
Reduced Time ◽  
Prostate Cancer Study

2 Background: The REDEEM (Reduction by Dutasteride of Clinical Progression Events in Expectant Management of Prostate Cancer) study tested whether dutasteride controlled growth of existing low risk, localized prostate cancer (PCa) and hence reduced the need for aggressive therapy in men followed with active surveillance. Methods: 302 men, aged 48–82, with PSA <11 ng/ml, and Gleason score ≤6 PCa (≤3 cores positive, <50% of any core positive) were randomized to dutasteride or placebo for 3 years. Repeat 12-core biopsies were performed at 18 and 36 months, or for-cause at other times during the study. The primary endpoint was time to progression, defined as the earliest of either pathological progression (Gleason score >6, ≥4 cores positive, or >50% of any core positive) or therapeutic progression (radical prostatectomy, radiation therapy, or hormonal ablation). Results: 96% of subjects reached the primary endpoint or had a post-baseline biopsy. Dutasteride reduced time to PCa progression (relative risk reduction 38.9%, 95% CI: 12.4–57.4%, P=0.007). The table presents incidence of progression and Gleason score on final biopsy. 23% of men (N=31) in the placebo group and 36% of men (N=50) in the dutasteride group had no cancer detected on their final biopsy. PCa-related anxiety was reduced in the dutasteride arm compared to the placebo arm (P=0.036), based on the Memorial Anxiety Scale for PCa (MAX-PC). Drug-related adverse events were similar to those previously reported for dutasteride. Conclusions: In men followed with active surveillance, dutasteride delayed the time to PCa progression, increased the percent of men with no detectable PCa, and improved PCa-related anxiety. There was no evidence of increased Gleason score upgrading with dutasteride. Dutasteride may provide a useful adjunct to active surveillance for management of PCa. [Table: see text] [Table: see text]

scholarly journals Natural history of prostate cancer on active surveillance: stratification by MRI using the PRECISE recommendations in a UK cohort

2020 ◽  
Author(s):  
Francesco Giganti ◽  
Armando Stabile ◽  
Vasilis Stavrinides ◽  
Elizabeth Osinibi ◽  
Adam Retter ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Gleason Score ◽  
Rank Test ◽  
Gleason Grade ◽  
Clinical Progression ◽  
Radiological Progression ◽  
Grade Group ◽  
Psa Density

Abstract Objectives The PRECISE recommendations for magnetic resonance imaging (MRI) in patients on active surveillance (AS) for prostate cancer (PCa) include repeated measurement of each lesion, and attribution of a PRECISE radiological progression score for the likelihood of clinically significant change over time. We aimed to compare the PRECISE score with clinical progression in patients who are managed using an MRI-led AS protocol. Methods A total of 553 patients on AS for low- and intermediate-risk PCa (up to Gleason score 3 + 4) who had two or more MRI scans performed between December 2005 and January 2020 were included. Overall, 2161 scans were retrospectively re-reported by a dedicated radiologist to give a PI-RADS v2 score for each scan and assess the PRECISE score for each follow-up scan. Clinical progression was defined by histological progression to ≥ Gleason score 4 + 3 (Gleason Grade Group 3) and/or initiation of active treatment. Progression-free survival was assessed using Kaplan-Meier curves and log-rank test was used to assess differences between curves. Results Overall, 165/553 (30%) patients experienced the primary outcome of clinical progression (median follow-up, 74.5 months; interquartile ranges, 53–98). Of all patients, 313/553 (57%) did not show radiological progression on MRI (PRECISE 1–3), of which 296/313 (95%) had also no clinical progression. Of the remaining 240/553 patients (43%) with radiological progression on MRI (PRECISE 4–5), 146/240 (61%) experienced clinical progression (p < 0.0001). Patients with radiological progression on MRI (PRECISE 4-5) showed a trend to an increase in PSA density. Conclusions Patients without radiological progression on MRI (PRECISE 1-3) during AS had a very low likelihood of clinical progression and many could avoid routine re-biopsy. Key Points • Patients without radiological progression on MRI (PRECISE 1–3) during AS had a very low likelihood of clinical progression and many could avoid routine re-biopsy. • Clinical progression was almost always detectable in patients with radiological progression on MRI (PRECISE 4–5) during AS. • Patients with radiological progression on MRI (PRECISE 4–5) during AS showed a trend to an increase in PSA density.

Multiparametric prostate MRI and MRI/ultrasound fusion biopsy as tools to follow prostate cancer progression for men on active surveillance.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 63-63 ◽  
Author(s):  
Nabeel Shakir ◽  
Annerleim Walton-Diaz ◽  
Soroush Rais-Bahrami ◽  
Baris Turkbey ◽  
Jason Rothwax ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Gleason Score ◽  
Cancer Progression ◽  
Predictive Value ◽  
Low Risk ◽  
Fusion Biopsy ◽  
Trus Biopsy ◽  
Risk Prostate Cancer ◽  
Low Risk Prostate Cancer

63 Background: Active surveillance (AS) is an option for patients with low risk prostate cancer (PCa); however, determining disease progression is challenging. At the NCI, multiparametric MRI (MP-MRI) with our biopsy protocol (MR-US fusion-guided plus 12 core extended sextant biopsy) has been used to confirm eligibility for AS. We evaluated the utility of these modalities in monitoring patients on AS. Methods: Patients who underwent MP-MRI of the prostate with biopsy per our protocol between 2007-2012 were reviewed. We selected a subset who met Johns Hopkins criteria for AS (Gleason score≤6, PSA density≤0.15, tumor involvement of ≤2 cores, and ≤50% of any single core) by outside 12−core TRUS biopsy. Patients with Gleason score≤6 confirmed at first NCI biopsy session were followed with annual MP-MRI and biopsy. MRI progression was defined as an increase in MP-MRI suspicion level, lesion diameter, or number of lesions. Pathologic progression was defined as an increase to Gleason score≥7 in either 12-core or MR-fusion biopsy. We determined the association between MRI and pathologic progression. Results: 129 patients met JHU criteria for AS by outside biopsy. Mean age was 61.6 years and mean PSA 5.16ng/mL. 28/129 (21.7%) patients had Gleason score ≥7 at first NCI biopsy session.31 patients had at least two biopsy sessions (mean follow up 18 months, range 12-54 months) of which 9/31 (29%) increased in Gleason score, all to 3+4=7. Fusion biopsy detected more pathologic progression than did standard biopsy (Table). The positive predictive value of MP-MRI for pathologic progression was 50%, while the negative predictive value was 84%. The sensitivity and specificity of MP-MRI for increase in Gleason score was 67% and 73%, respectively. Conclusions: Stable findings on MP-MRI are associated with Gleason score stability in patients with low-risk PCa choosing AS. The majority of patients who had pathologic progression were detected on fusion biopsy, which may suggest that random biopsies are unnecessary in this population. Larger studies are needed to validate these findings. [Table: see text]

Association of baseline perineural invasion with shorter time to progression in men with prostate cancer undergoing active surveillance: Results from the REDEEM study.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 23-23
Author(s):  
Daniel M. Moreira ◽  
Neil Eric Fleshner ◽  
Stephen J. Freedland
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Perineural Invasion ◽  
Cox Model ◽  
Multivariable Analysis ◽  
Specific Antigen ◽  
Expectant Management ◽  
Time To Progression ◽  
Kaplan Meier

23 Background: Perineural invasion (PNI) on prostate cancer (PC) biopsies has been associated with disease upgrading among those undergoing radical prostatectomy. However, the clinical significance of PNI in men on active surveillance (AS) has been evaluated by a limited number of studies. Thus, we sought to evaluate the association of PNI with time to clinical and pathological progression in men with PC on AS. Methods: Retrospective analysis of 289 men 48 to 82 years old on AS for low-risk PC (T1c-T2a), Gleason ≤6, ≤3 positive cores, ≤50% of any core involved, prostate-specific antigen (PSA) ≤11ng/ml, life expectancy >5 years and follow-up data in the REduction by Dutasteride of clinical progression Events in Expectant Management study. Progression was divided in pathological (>3 positive cores, >50% core involvement or Gleason >6 in a repeat biopsy) or therapeutic (any treatment for PC) or both. Time to progression was analyzed with Kaplan-Meier plots, log-rank tests and Cox model adjusting for age, PSA density, percent cores involved, maximum core involvement and treatment. Results: A total of 11 (4%) patients had PNI on baseline biopsy. PNI was associated with higher tumor length and maximum core involvement (all P<0.05). PNI was not associated with patient’s age, race, PSA levels or density, percent or number of positive cores. After a median follow-up of 37 months, 125 (43%) patients developed progression. Of these, 95 (76%) patients had pathological and 30 (24%) had therapeutic progression. In univariable analysis, patients with baseline PNI had a shorter time to overall and pathological progression (HR=2.62, 95%CI=1.31-5.23, P=0.006 and HR=2.42, 95%CI=1.03-5.66, P=0.041, respectively). Similar results were obtained in multivariable analysis for overall and pathological progression (HR=2.26, 95%CI=1.10-4.68, P=0.028 and HR=2.13, 95%CI=0.88-5.13, P=0.092, respectively). Conclusions: Among patients with PC on AS, PNI is independently associated with shorter time to progression. Thus, PNI may be used to help select patients for AS and stratify them according to the risk of disease progression.

scholarly journals Multiparametric magnetic resonance imaging can exclude prostate cancer progression in patients on active surveillance: a retrospective cohort study

2020 ◽  
Vol 30 (11) ◽  
pp. 6042-6051 ◽  
Author(s):  
T. Ullrich ◽  
C. Arsov ◽  
M. Quentin ◽  
F. Mones ◽  
A. C. Westphalen ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Tumor Progression ◽  
Active Surveillance ◽  
Gleason Score ◽  
Cancer Progression ◽  
Predictive Value ◽  
Transrectal Ultrasound ◽  
Minimum Interval ◽  
Sensitivity Specificity

Abstract Objectives To assess the ability of multiparametric MRI (mp-MRI) of the prostate to exclude prostate cancer (PCa) progression during monitoring patients on active surveillance (AS). Methods One hundred forty-seven consecutive patients on AS with mp-MRI (T2WI, DWI, DCE-MRI) at 3T were initially enrolled. Fifty-five received follow-up mp-MRI after a minimum interval of 12 months and subsequent targeted MR/US fusion-guided biopsy (FUS-GB) plus concurrent systematic transrectal ultrasound-guided (TRUS-GB) biopsy as reference standard. Primary endpoint was the negative predictive value (NPV) of the follow-up mp-MRI to exclude histopathologic tumor progression using PRECISE recommendations. Secondary endpoints were the positive predictive value (PPV), sensitivity, specificity, Gleason score (GS) upgrades, and comparison of biopsy method. Results Of 55 patients, 29 (53%) had a GS upgrade on re-biopsy. All 29 patients showed a tumor progression on follow-up mp-MRI. Fifteen of 55 patients (27%) displayed signs of tumor progression, but had stable GS on re-biopsy. None of the 11 patients (20%) without signs of progression on follow-up mp-MRI had a GS upgrade on re-biopsy. The NPV was 100%, PPV was 66%, sensitivity was 100%, and specificity 42%. FUS-GB resulted in GS upgrade significantly more often (n = 28; 51%) compared with TRUS-GB (n = 12; 22%; p < 0.001). Conclusions (Follow-up) Mp-MRI can reliably exclude PCa progression in patients on AS. Standard serial re-biopsies might be waived if follow-up mp-MRIs are stable. Over 60% of patients with signs of tumor progression on mp-MRI during AS had a GS upgrade on re-biopsy. Targeted re-biopsies should be performed if cancer progression or higher-grade PCa is suspected on mp-MRI. Key Points • None of the patients with unsuspicious mp-MRI had a GS upgrade in re-biopsy and mp-MRI might replace serial biopsies in these cases • More than 60% of patients with mp-MRI signs of tumor progression had subsequent Gleason score (GS) upgrades • Targeted re-biopsies should be performed in case of higher GS cancer suspicion on mp-MRI

scholarly journals A novel predictor of clinical progression in patients on active surveillance for prostate cancer

2019 ◽  
Vol 13 (8) ◽  
Author(s):  
Guan Hee Tan ◽  
Antonio Finelli ◽  
Ardalan Ahmad ◽  
Marian Wettstein ◽  
Alexandre Zlotta ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Cox Regression ◽  
Area Under The Curve ◽  
Progression Free Survival ◽  
Roc Curves ◽  
Standard Of Care ◽  
Low Risk ◽  
Clinical Progression

Introduction: Active surveillance (AS) is standard of care in low-risk prostate cancer (PC). This study describes a novel total cancer location (TCLo) density metric and aims to determine its performance in predicting clinical progression (CP) and grade progression (GP).     Methods: This was a retrospective study of patients on AS after confirmatory biopsy (CBx). We excluded patients with Gleason ≥7 at CBx and <2 years follow-up. TCLo was the number of locations with positive cores at diagnosis (DBx) and CBx. TCLo density was TCLo / prostate volume (PV). CP was progression to any active treatment while GP occurred if Gleason ≥7 was identified on repeat biopsy or surgical pathology. Independent predictors of time to CP or GP were estimated with Cox regression. Kaplan-Meier analysis compared progression-free survival curves between TCLo density groups. Test characteristics of TCLo were explored with receiver operating characteristic (ROC) curves.     Results: We included 181 patients who had CBx between 2012-2015, and met inclusion criteria. The mean age of patients was 62.58 years (SD=7.13) and median follow-up was 60.9 months (IQR=23.4). A high TCLo density score (>0.05) was independently associated with time to CP (HR 4.70, 95% CI: 2.62-8.42, p<0.001), and GP (HR 3.85, 95% CI: 1.91-7.73, p<0.001). ROC curves showed TCLo density has greater area under the curve than number of positive cores at CBx in predicting progression.     Conclusion: TCLo density is able to stratify patients on AS for risk of CP and GP. With further validation, it could be added to the decision-making algorithm in AS for low-risk localized PC.

Adverse Disease Features in Gleason Score 3 + 4 “Favorable Intermediate-Risk” Prostate Cancer: Implications for Active Surveillance

2017 ◽  
Vol 72 (3) ◽  
pp. 442-447 ◽  
Author(s):  
Alessandro Morlacco ◽  
John C. Cheville ◽  
Laureano J. Rangel ◽  
Derek J. Gearman ◽  
R. Jeffrey Karnes
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Gleason Score ◽  
Intermediate Risk ◽  
Risk Prostate Cancer

scholarly journals Comparative performance of MRI-derived PRECISE scores and delta-radiomics models for the prediction of prostate cancer progression in patients on active surveillance

2021 ◽  
Author(s):  
Nikita Sushentsev ◽  
Leonardo Rundo ◽  
Oleg Blyuss ◽  
Tatiana Nazarenko ◽  
Aleksandr Suvorov ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Cancer Progression ◽  
Predictive Value ◽  
Machine Learning Algorithms ◽  
Superior Performance ◽  
Control Group ◽  
P Value ◽  
Lasso Regression

Abstract Objectives To compare the performance of the PRECISE scoring system against several MRI-derived delta-radiomics models for predicting histopathological prostate cancer (PCa) progression in patients on active surveillance (AS). Methods The study included AS patients with biopsy-proven PCa with a minimum follow-up of 2 years and at least one repeat targeted biopsy. Histopathological progression was defined as grade group progression from diagnostic biopsy. The control group included patients with both radiologically and histopathologically stable disease. PRECISE scores were applied prospectively by four uro-radiologists with 5–16 years’ experience. T2WI- and ADC-derived delta-radiomics features were computed using baseline and latest available MRI scans, with the predictive modelling performed using the parenclitic networks (PN), least absolute shrinkage and selection operator (LASSO) logistic regression, and random forests (RF) algorithms. Standard measures of discrimination and areas under the ROC curve (AUCs) were calculated, with AUCs compared using DeLong’s test. Results The study included 64 patients (27 progressors and 37 non-progressors) with a median follow-up of 46 months. PRECISE scores had the highest specificity (94.7%) and positive predictive value (90.9%), whilst RF had the highest sensitivity (92.6%) and negative predictive value (92.6%) for predicting disease progression. The AUC for PRECISE (84.4%) was non-significantly higher than AUCs of 81.5%, 78.0%, and 80.9% for PN, LASSO regression, and RF, respectively (p = 0.64, 0.43, and 0.57, respectively). No significant differences were observed between AUCs of the three delta-radiomics models (p-value range 0.34–0.77). Conclusions PRECISE and delta-radiomics models achieved comparably good performance for predicting PCa progression in AS patients. Key Points • The observed high specificity and PPV of PRECISE are complemented by the high sensitivity and NPV of delta-radiomics, suggesting a possible synergy between the two image assessment approaches. • The comparable performance of delta-radiomics to PRECISE scores applied by expert readers highlights the prospective use of the former as an objective and standardisable quantitative tool for MRI-guided AS follow-up. • The marginally superior performance of parenclitic networks compared to conventional machine learning algorithms warrants its further use in radiomics research.

Sign in / Sign up

Export Citation Format

Share Document