“Management Migration” in United States patients diagnosed with localized prostate cancer from 2010-2015.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 11-11
Author(s):  
Santino Butler ◽  
Idalid Ivy Franco ◽  
Amandeep R Mahal ◽  
Nina Niu Sanford ◽  
Quoc-Dien Trinh ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Groups ◽  
Low Risk ◽  
Risk Category ◽  
Intermediate Risk ◽  
National Guidelines ◽  
Initial Management ◽  
Public Surveillance ◽  
Risk Prostate Cancer ◽  
Cancer Network

11 Background: National guidelines have increasingly supported active surveillance/watchful waiting (AS/WW) in low- and favorable intermediate-risk prostate cancer (PCa). It is unknown how these changes have influenced national management patterns across localized PCa. Therefore, we sought to define the U.S. trends in management of localized PCa across National Comprehensive Cancer Network (NCCN) risk groups. Methods: Using the novel and non-public Surveillance, Epidemiology, and End Results Program Prostate with AS/WW Database, we identified 164,760 men diagnosed with localized PCa and actively treated with either AS/WW, radical prostatectomy [RP], or radiation therapy [RT] from 2010-2015. Rates of initial management type over time, stratified by NCCN risk-category, were determined. Multivariable logistic regression defined adjusted odds ratios (AORs) and 95% confidence intervals (CI) for receipt of each initial management type, with year of diagnosis (2010-2015) as the independent variable of interest (Year 2010 = referent). Results: AS/WW utilization increased from 14.5% to 42.1% from 2010-2015 in low-risk disease (AOR 4.50 [95% CI 4.17–4.86, P < 0.001]); conversely, RT and RP decreased from 38.0% to 26.6% (AOR 0.55 [0.51–0.59, P < 0.001]), and from 47.4% to 31.3% (AOR 0.50, [0.47-0.54, P < 0.001]), respectively (all Ptrends< 0.001). AS/WW increased in intermediate-risk disease from 5.78% to 9.60% (AOR 1.83 [1.67–2.00, P < 0.001]) and RT also decreased from 42.4% to 39.8% (AOR 0.81 [0.77–0.85], P < 0.001; Ptrends< 0.001)—Yet, there was no change in RP (51.8% vs. 50.6%; AOR 1.03 [0.98–1.09, P = 0.254]). Notably, while RP for high-risk disease increased from 38.0% to 42.8% (AOR 1.41 [1.30–1.53, P < 0.001]), RT decreased from 60.1% to 55.0% (AOR 0.71 [0.65–0.77, P < 0.001]; Ptrends< 0.001). Conclusions: These findings capture the rapidly shifting landscape of management for localized PCa and are suggestive of “management migration”—where down-trending RP utilization in low-risk disease (in the setting of up-trending AS/WW) may drive non-evidence based management bias toward RP over RT in higher risk disease. These national patterns serve as a targetable trend that should be addressed.

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

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]

scholarly journals Association between a 17-gene genomic prostate score and multiparametric prostate MRI in men with low- and intermediate-risk prostate cancer (PCa).

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 83-83
Author(s):  
Michael S. Leapman ◽  
Antonio C. Westphalen ◽  
Niloufar Ameli ◽  
H. Jeffrey Lawrence ◽  
Phillip G. Febbo ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Groups ◽  
Low Risk ◽  
Intermediate Risk ◽  
Mri Findings ◽  
Broad Distribution ◽  
Prostate Mri ◽  
Apparent Diffusion ◽  
Risk Prostate Cancer ◽  
Risk Patients

83 Background: A biopsy-based RT-PCR assay (Oncotype DX Prostate Assay) providing a Genomic Prostate Score (GPS) as a measure of tumor aggressiveness and multi-parametric prostate MRI (mpMRI) are clinically utilized predictors of adverse pathology at prostatectomy. These tests have not been directly compared and it remains to be determined whether they provide independent information. Methods: We evaluated the association between GPS results (scale 0-100) and baseline endorectal mpMRI in men with clinically localized PCa. MR studies were reviewed to a five-tier scale of increasing suspicion of malignancy. Mean apparent diffusion coefficient (ADC) was calculated from a single dominant lesion. Mean rank of the GPS (0-100) and GPS-predicted likelihood of favorable pathology among MRI strata were compared with the Kruskal-Wallis test. Regression analysis was performed between mean ADC and scaled GPS within CAPRA risk groups. Results: Of 332 patients who received GPS testing at a single institution, 94 were identified with low (n=59) and intermediate (n=35) CAPRA risk prostate cancer who received mpMRI within a two-year interval of prostate biopsy. A broad distribution of GPS was observed across categories defined by mpMRI criteria. Among intermediate risk patients both GPS and the GPS-predicted likelihood of favorable pathology were associated with MR score (p=0.01 and p<0.01, respectively). For low risk patients, neither GPS nor likelihood of favorable pathology were significantly different across MR findings (p=0.12 and p=0.21, respectively). Mean ADC was not significantly associated with GPS or likelihood of favorable pathology for either low (p=0.24) or intermediate (p=0.91) risk categories. Conclusions: While a broad distribution of GPS was observed across mpMRI criteria, increasing GPS was associated with highly suspicious MRI findings in men with intermediate risk PCa. No significant associations were observed between MRI categories and either GPS or likelihood of adverse pathology in low risk patients.

Population-based 10-year oncologic outcomes after low-dose-rate brachytherapy for low-risk and intermediate-risk prostate cancer

Cancer ◽  
2012 ◽  
Vol 119 (8) ◽  
pp. 1537-1546 ◽  
Author(s):  
W. James Morris ◽  
Mira Keyes ◽  
Ingrid Spadinger ◽  
Winkle Kwan ◽  
Mitchell Liu ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Dose Rate ◽  
Low Dose ◽  
Population Based ◽  
Low Risk ◽  
Oncologic Outcomes ◽  
Intermediate Risk ◽  
Low Dose Rate ◽  
Risk Prostate Cancer ◽  
Low Dose Rate Brachytherapy

scholarly journals Prostate Cancer Grade and Stage Misclassification in Active Surveillance Candidates: Black Versus White Patients

2020 ◽  
Vol 18 (11) ◽  
pp. 1492-1499
Author(s):  
Lara Franziska Stolzenbach ◽  
Giuseppe Rosiello ◽  
Angela Pecoraro ◽  
Carlotta Palumbo ◽  
Stefano Luzzago ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Temporal Trend ◽  
Low Risk ◽  
Intermediate Risk ◽  
Multivariate Logistic Regression ◽  
Black Patients ◽  
Risk Prostate Cancer ◽  
Misclassification Rates ◽  
White Patients

Background: Misclassification rates defined as upgrading, upstaging, and upgrading and/or upstaging have not been tested in contemporary Black patients relative to White patients who fulfilled criteria for very-low-risk, low-risk, or favorable intermediate-risk prostate cancer. This study aimed to address this void. Methods: Within the SEER database (2010–2015), we focused on patients with very low, low, and favorable intermediate risk for prostate cancer who underwent radical prostatectomy and had available stage and grade information. Descriptive analyses, temporal trend analyses, and multivariate logistic regression analyses were used. Results: Overall, 4,704 patients with very low risk (701 Black vs 4,003 White), 17,785 with low risk (2,696 Black vs 15,089 White), and 11,040 with favorable intermediate risk (1,693 Black vs 9,347 White) were identified. Rates of upgrading and/or upstaging in Black versus White patients were respectively 42.1% versus 37.7% (absolute Δ = +4.4%; P<.001) in those with very low risk, 48.6% versus 46.0% (absolute Δ = +2.6%; P<.001) in those with low risk, and 33.8% versus 35.3% (absolute Δ = –1.5%; P=.05) in those with favorable intermediate risk. Conclusions: Rates of misclassification were particularly elevated in patients with very low risk and low risk, regardless of race, and ranged from 33.8% to 48.6%. Recalibration of very-low-, low-, and, to a lesser extent, favorable intermediate-risk active surveillance criteria may be required. Finally, our data indicate that Black patients may be given the same consideration as White patients when active surveillance is an option. However, further validations should ideally follow.

Phase 2b trial results of padeliporfin (WST11 or Tookad) vascular-targeted photodynamic therapy for partial gland ablation in men with intermediate-risk prostate cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e17006-e17006
Author(s):  
Jonathan Coleman ◽  
Daniel D. Sjoberg ◽  
Quinlan Demac ◽  
Catriona ODea ◽  
Marlena McGill ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Primary Endpoint ◽  
Low Risk ◽  
Gleason Grade ◽  
Intermediate Risk ◽  
Function Score ◽  
Trus Biopsy ◽  
Risk Prostate Cancer ◽  
Partial Gland Ablation ◽  
Targeted Photodynamic Therapy

e17006 Background: Padeliporfin (WST11) vascular-targeted photodynamic therapy (VTP) has shown significant clinical benefit as a localized partial gland ablation (PGA) therapy when compared to active surveillance for low-risk prostate cancer, by curbing progression and the need for radical treatment, leading to its regulatory approval in Europe. This phase 2b trial prospectively investigated WST11-VTP for intermediate-risk cancers. Methods: Men with unilateral Grade Group 2 (GG2) cancers (Gleason 3+4), evaluated with MRI and ultrasound-guided (TRUS) biopsy, underwent up to two WST11-VTP PGA sessions. Eligibility criteria included <cT2b, PSA < 10, and fusion biopsy for PIRADS 3+ lesions on pretreatment MRI. Contralateral very low–risk disease was observed. The primary endpoint was prevalence of any Gleason Grade 4 or 5 (≥GG2) cancer, determined by MRI and systematic, 14-core TRUS biopsy of the entire gland (+/- fusion) at 3 and 12 months after treatment. Treatment safety and patient-reported quality of life for sexual and urinary function were assessed with validated questionnaires (IIEF-15 and IPSS, respectively). The study was powered using β = 0.2 to reject the null hypothesis (r≤70%), using a one-sided exact binomial test with 5% alpha risk. To be valid, 44 evaluable patients were required for the 12-month primary endpoint assessment. Results: Of the 50 men treated, 46 were evaluable for the 12-month primary endpoint. Before 12 months, 1 man proceeded to prostatectomy (treatment failure), 2 men refused 12-month biopsy, and 1 man died of COVID-19. At 3 months, 12/49 (24%) men underwent per protocol second WST11-VTP PGA session for GG2 tumor: 9 for residual cancer and 4 for newly identified contralateral GG2 tumors (1 bilateral). The 12-month biopsy was performed in 45 men; 38 (83%) had no Gleason grade 4 or 5 cancer, including 11/12 (92%) patients who underwent 2 PGA sessions. By 3 months, median decline in erectile function score (IIEF-5) from baseline was -1.0 (IQR -7,0). Median improvement in urinary function score (IPSS) was -1.0 (IQR -1,5), with pad-free continence observed in all patients. Median change in IIEF score by 12-months was -1.0 (IQR -5,0). Grade 3 treatment-related adverse events occurred in 6 (12%) patients. All procedure-related prostate/pelvic pain resolved by 3 weeks. Conclusions: The positive results from this trial show that WST11-VTP is effective for PGA of intermediate-risk prostate cancer, with minimal toxicity or impact on urinary and sexual function, consistent with the phase 3 trial results in low-risk disease. Based on these data, this therapy bears consideration for approval as a conservative therapeutic option for selected cases of intermediate-risk disease. Clinical trial information: NCT03315754.

The impact of neoadjuvant hormone therapy on the permanent 125I-seed brachytherapy for low- or intermediate-risk prostate cancer.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 201-201
Author(s):  
Ryuta Tanimoto ◽  
Kensuke Bekku ◽  
Shin Ebara ◽  
Motoo Araki ◽  
Hiroyuki Yanai ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Gleason Score ◽  
Hormonal Therapy ◽  
Low Risk ◽  
Prostate Brachytherapy ◽  
Intermediate Risk ◽  
Neoadjuvant Hormonal Therapy ◽  
T Stage ◽  
Risk Prostate Cancer ◽  
The Impact

201 Background: To determine whether neoadjuvant hormonal therapy improves the biochemical outcome for men with low or intermediate risk prostate cancer and undergoing permanent brachytherapy. Methods: From January 2004 to April 2011, 449 patients with low-risk (221 men) or intermediate-risk (228 men) based on NCCN guideline underwent transperineal ultrasonography-guided permanent 125I-seed brachytherapy. Of these patients, 186 received neoadjuvant hormonal therapy (NHT). The median patient age was 67 years. The median follow-up (SD) was 48 (20) months (calculated from the day of implantation). Biochemical disease-free (BDF) survival was defined using Phoenix definition. The clinical variables evaluated for BDF survival included presence of NHT, Gleason score, clinical T-stage and pretreatment PSA. Results: For all patients, the 1, 3, 5-year actuarial BDF survival rates were 99.2%, 96.2% and 90% without NHT, 100%, 97.2%, 91.0% with NHT (p=0.954). When stratified by risk group, NHT did not improve the outcome for patients at low risk (P = 0.745) or at intermediate risk (P = 0.888). The duration (<= 5 vs >5 months) or combinations (single vs combined androgen blockade) of hormonal therapy were not statistically significant in predicting biochemical recurrence. In a multivariate analysis (shown below), only the Gleason score was a strong predicting factor, while NHT as well as pretreatment PSA, T stage were insignificant. Conclusions: In patients treated by permanent prostate brachytherapy, NHT did not improve the biochemical outcome for those at low-risk or intermediate-risk features. Furthermore, the duration or combinations of hormonal therapy conferred no additional biochemical advantage. [Table: see text]

Gleason score upgrade among 10,282 men who underwent surgery as initial treatment in 2010: A population-based study.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 72-72
Author(s):  
Hong Zhang ◽  
Edward M. Messing ◽  
Hamza Ahmed ◽  
Yuhchyau Chen
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Gleason Score ◽  
Specific Antigen ◽  
Low Risk ◽  
Categorical Variables ◽  
Intermediate Risk ◽  
Time Of Surgery ◽  
Significant Difference ◽  
Risk Prostate Cancer

72 Background: Active surveillance is now accepted initial management for men who have localized prostate cancer with low risk of disease progression. Many criteria have been used for patient identification, including Gleason score (GS) obtained from prostate biopsy. Because of concerns of sampling error, some have recommended repeated biopsy before committing to active surveillance. However, there is limited information about the risk of missing high grade disease using the current standard biopsy approach. This study seeks to compare GS difference from biopsy and surgery to provide an estimated rate of GS upgrade. Methods: The Surveillance, Epidemiology, and End Results (SEER) program was used to identify men with American Joint Committee on Cancer stage T1-2cN0M0 prostate cancer diagnosed between January 2010 and December 2010. Patients who underwent prostatectomy were selected for further analysis. Based on prostate-specific antigen (PSA) levels and GS, cases were divided into low (PSA <=10 and GS <=6) and intermediate (10<PSA<=20 or GS=7) risk groups. The rates of GS upgrade were reported for each group. Chi-square tests were used to assess differences in categorical variables (e.g. age and race) between groups of GS upgrade and no change/downgrade. Results: A total of 10,282 men were evaluated, with 9.2% (n=942) having low-risk disease, and 90.8% (n=9340) having intermediate-risk disease. Among men with low-risk prostate cancer, 22.3% (n=210) had GS upgrade and 0.8% (n=8) had GS 8 disease. Among men with intermediate risk disease, 26.2% (n=2446) had GS upgrade and 2.3% (n=214) had GS 8 disease. There was no statistically significant difference in either age or race distribution among men who had GS upgrade versus no change or downgrade at the time of surgery. Conclusions: A substantial number of low- and intermediate-risk prostate cancer patients had GS upgrade at the time of surgery, but few had upgraded to GS 8 high risk disease. These observations suggest that repeat biopsy prior to active surveillance may not be necessary.

Performance of MRI-TRUS-guided fusion biopsy to detect progression on active surveillance for low- and intermediate-risk prostate cancer.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 43-43
Author(s):  
Thomas P. Frye ◽  
Nabeel Ahmad Shakir ◽  
Steven Abboud ◽  
Arvin Koruthu George ◽  
Maria J Merino ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Low Risk ◽  
Intermediate Risk ◽  
Targeted Biopsy ◽  
Fusion Biopsy ◽  
Trus Biopsy ◽  
Guided Biopsy ◽  
Risk Prostate Cancer

43 Background: Active surveillance (AS) is an established treatment option for men with low risk prostate cancer. Its role in intermediate prostate cancer is still being investigated. Recent studies have shown that multiparametric-MRI (mp-MRI) along with MRI-TRUS fusion-guided biopsy 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 determine the performance of MRI-TRUS guided biopsy for men on AS with both low and intermediate risk disease. Methods: Between 2007-2014 men on AS were included if they had complete mp-MRI and pathology data for 2 or more MRI-TRUS biopsy sessions. Fusion guided biopsy procedures consisted of MRI identified targeted biopsies as well as random 12 core biopsies. Men were allowed to participate in AS with low and intermediate risk prostate cancer, Gleason score ≤ 3+4=7. 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: 89 men met our study criteria with an average age of 62 years old (range 45-79). 75 men had low risk Gleason 3+3=6 at the outset of AS by 1st biopsy session with a median PSA 5.1 ng/ml. The other 14 men had intermediate risk prostate cancer Gleason 3+4=7 at the outset of AS and a median PSA 4.6 ng/ml. During follow-up, 25 (33%) low risk men progressed to 3+4 or above at a median of 20.6 months. Of these, 19 were found by targeted biopsy. 6 (43%) of the intermediate risk men progressed to Gleason 4+3=7 at a median of 36.8 months. 4 of these progressed on targeted fusion biopsy. In the intermediate risk men, 84 random biopsy cores were require to detect 1 progression versus 15 targeted biopsy cores to detect 1 progression. Conclusions: The majority of patients on AS who progressed were identified by MRI-TRUS targeted biopsy. Less biopsy cores are required to detect progression with targeted biopsy. These results are preliminary and a larger cohort with longer follow-up would be beneficial.

OncotypeDx genomic scores independent of disease volume in men with favorable-risk prostate cancer.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 93-93
Author(s):  
Dominic C. Grimberg ◽  
Yaw A. Nyame ◽  
Daniel J. Greene ◽  
Karishma Gupta ◽  
Ryan Kent Berglund ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Low Risk ◽  
Intermediate Risk ◽  
Psa Density ◽  
Risk Prostate Cancer ◽  
Clinically Significant

93 Background: To determine if disease volume at biopsy correlates with GPS among men with favorable risk prostate cancer. Methods: All men with NCCN very low (VLR) and low risk (LR) and GPS from 2013-2016 were identified. Disease volume was characterized by percent of positive cores, number of cores with >50% involvement, and largest involvement of any single core. Nonparametric equality of medians was performed to compare the median likelihood of favorable pathology between quartiles. Results: 112 (37.8%) with VLR and 184 (62.2%) with LR disease were identified. The likelihood of favorably pathology by quartile are listed in Table 1. 7/105 (6.3%) with VLR were reclassified as LR, and 13/181 (7.2%) with LR were reclassified as intermediate risk (IR). Patients reclassified to IR by GPS had a median likelihood favorable pathology of 63.0% (IQR 62.0-63.0), 20.0% positive cores (IQR 13.0-29.0), 0 cores with > 50% involved (IQR 0-1), largest core involvement of 20.0% (IQR 10.0-20.0), and PSA density of 0.12 ng/ml/cc (IQR 0.10-0.14). Conclusions: Differences in the likelihood of favorable pathology by disease volume were not clinically significant in men with favorable risk disease. [Table: see text]

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