The prognostic impact of a negative confirmatory biopsy in men on active surveillance for prostate cancer.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 76-76
Author(s):  
Keyan Salari ◽  
Dimitar V. Zlatev ◽  
David Kuppermann ◽  
Mark A. Preston ◽  
Douglas M. Dahl ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Proportional Hazards ◽  
Clinical Stage ◽  
Intraepithelial Neoplasia ◽  
Cox Proportional Hazards ◽  
Prognostic Impact ◽  
Atypical Small Acinar Proliferation ◽  
Diagnostic Biopsy

76 Background: Active surveillance (AS) is increasingly used in managing low-risk and favorable intermediate-risk prostate cancer. To mitigate the risk of unsampled higher risk disease, most institutional AS protocols call for a confirmatory prostate biopsy within 12-18 months following initial diagnostic biopsy. Here, we investigate whether the results of confirmatory biopsy impact the outcomes of men on AS. Methods: We retrospectively reviewed our institutional database of men enrolled in AS between 1997-2014 with a minimum follow-up of 6 months (n = 974). Biopsies with any prostate cancer were considered positive. Biopsies containing only benign prostatic tissue, prostatic intraepithelial neoplasia (PIN), or atypical small acinar proliferation (ASAP) were considered negative. Statistical analysis was conducted using the Kaplan-Meier method and Cox proportional hazards regression. Results: At diagnosis, median age was 67 years (IQR 62-72) and median PSA was 5.1 ng/mL (IQR 3.9-6.8). The vast majority of patients had Gleason ≤6 (97%) and clinical stage T1 (92%) disease. With a median follow-up of 4.8 years, 702 (72%) patients underwent a confirmatory biopsy. 67% of confirmatory biopsies were positive for prostate cancer; 33% were negative (167 benign, 40 PIN, and 22 ASAP). Of the 702 patients, 33% progressed to treatment, with pathologic progression the most common reason (77%). Univariate predictors of progression to treatment included initial clinical stage ( P= 0.04), involvement of > 20% of any core on diagnostic biopsy ( P < 0.01), PSA density ≥0.15 ( P < 0.001), and confirmatory biopsy status ( P < 10-14). In multivariate analysis, a negative confirmatory biopsy remained the strongest predictor of progression to treatment (HR 0.12 [95%CI 0.06-0.24], P < 10-8). Confirmatory biopsy status was not associated with risk of adverse pathology on RP, metastasis-free survival, disease-specific survival, or overall survival. Conclusions: A negative confirmatory biopsy is associated with a significantly lower rate of progression to treatment among men on AS. This may serve as a useful tool for prognostication and help determine the need for further repeat biopsies for men on AS.

The relative contributions of the Genomic Prostate Score and comorbidity profile in predicting outcomes in surgically treated men with clinically low and intermediate-risk prostate cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e16607-e16607
Author(s):  
Jennifer Cullen ◽  
Dudith Pierre-Victor ◽  
H. Jeffrey Lawrence ◽  
Huai-Ching Kuo ◽  
Isabell Sesterhenn ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Intermediate Risk ◽  
Free Survival ◽  
Risk Prostate Cancer ◽  
Risk Stratum ◽  
Diagnostic Biopsy ◽  
Using Data

e16607 Background: The 17-gene Oncotype Dx Genomic Prostate Score® (GPS™) assay has been validated as a predictor of aggressive prostate cancer (PCa) in men treated with radical prostatectomy (RP) for clinically low and intermediate risk PCa. This study examined the performance of the GPS assay as a predictor of adverse pathology (AP) and biochemical recurrence (BCR)-free survival (BRFS), after adjusting for the presence of major comorbidities commonly seen in older men. Methods: Additional analyses were performed using data from a prior clinical validation study of the GPS assay. GPS values (scaled 0-100), determined from diagnostic biopsy tissue, were categorized into 3 levels: lowest quartile (Q1), middle quartiles (combined Q2-Q3) versus the highest quartile (Q4). Major comorbidities included heart disease, stroke, COPD, and other cancers. The associations between GPS result and the presence of ≥1 major comorbidity and outcomes were examined. AP was defined as high-grade (Gleason Score ≥ 4+3) and/or pT3 tumor. BCR was defined as 2 successive PSA levels > 0.2 ng/mL. Logistic regression analysis was used to examine AP; Cox proportional hazards analysis was used to model BRFS. Results: Among 389 eligible men, median age at diagnosis and follow-up time was 62 and 5.6 years, respectively. The prevalence of ≥1 major comorbidity differed significantly across GPS category, rising from 10.2% to 19.7% to 25.5% for GPS Quartiles 1, 2-3, and 4, respectively (p = 0.0024). However, presence of ≥1 major comorbidity was not a significant predictor of AP or BCR in multivariable models with GPS, age, race, and NCCN risk stratum. Men whose GPS result was in the highest quartile had 4-fold higher odds of AP (OR: 4.1; 95% CI = 2.1-7.99, p < 0.0001) at RP and a 3.5 times higher risk of BCR (HR = 3.49; 95% CI = 1.59-7.64, p = 0.002) compared to men in the lowest GPS quartile (Table 1). Conclusions: A high GPS result remains the strongest predictor of BCR and AP in this cohort of low and intermediate risk PCa men, after adjusting for the presence of major comorbidities. Further work will explore the relationships between specific comorbidities and metabolic syndrome, with GPS testing and PCa outcomes.

scholarly journals Prospective Study of Determinants and Outcomes of Deferred Treatment or Watchful Waiting Among Men With Prostate Cancer in a Nationwide Cohort

2009 ◽  
Vol 27 (30) ◽  
pp. 4980-4985 ◽  
Author(s):  
William V. Shappley ◽  
Stacey A. Kenfield ◽  
Julie L. Kasperzyk ◽  
Weiliang Qiu ◽  
Meir J. Stampfer ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prospective Study ◽  
Proportional Hazards ◽  
Clinical Stage ◽  
Specific Antigen ◽  
Cox Proportional Hazards ◽  
Deferred Treatment ◽  
Cox Proportional Hazards Models ◽  
A Prospective Study

Purpose To examine consequences of deferred treatment (DT) as initial management of prostate cancer (PCa) in a contemporary, prospective cohort of American men diagnosed with PCa. Participants and Methods We evaluated deferred treatment for PCa in the Health Professionals Follow-up Study, a prospective study of 51,529 men. Cox proportional hazards models were used to calculate hazard ratios (HRs) for time to eventual treatment among men who deferred treatment for more than 1 year after diagnosis. HRs for time to metastasis or death as a result of PCa were compared between patients who deferred treatment and those who underwent immediate treatment within 1 year of diagnosis. Results From among 3,331 cohort participants diagnosed with PCa from 1986 to 2007, 342 (10.3%) initially deferred treatment. Of these, 174 (51%) remained untreated throughout follow-up (mean 7.7 years); the remainder were treated an average of 3.9 years after diagnosis. Factors associated with progression to treatment among DT patients included younger age, higher clinical stage, higher Gleason score, and higher prostate-specific antigen at diagnosis. We observed similar rates for development of metastases (n = 20 and n = 199; 7.2 v 8.1 per 1,000 person-years; P = .68) and death as a result of PCa (n = 8 and n = 80; 2.4 v 2.6 per 1,000 person-years; P = .99) for DT and immediate treatment, respectively. Conclusion In this nationwide cohort, more than half the men who opted for DT remained without treatment for 7.7 years after diagnosis. Older men and men with lesser cancer severity at diagnosis were more likely to remain untreated. PCa mortality did not differ between DT and active treatment patients.

scholarly journals Subsequent prostate cancer detection in patients with prostatic intraepithelial neoplasia or atypical small acinar proliferation

2012 ◽  
Vol 1 (3) ◽  
Author(s):  
Moamen A. Amin ◽  
Suganthiny Jeyaganth ◽  
Nader Fahmy ◽  
Louis Bégin ◽  
Samuel Aronson ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Detection ◽  
Specific Antigen ◽  
Intraepithelial Neoplasia ◽  
Prostatic Intraepithelial Neoplasia ◽  
Atypical Small Acinar Proliferation ◽  
Psa Density ◽  
Significant Difference ◽  
Initial Biopsy

Introduction: To evaluate the predictors of prostate cancer in follow-up of patientsdiagnosed on initial biopsy with high-grade prostatic intraepithelial neoplasia(HGPIN) or atypical small acinar proliferation (ASAP).Methods: We studied 201 patients with HGPIN and 22 patients with ASAPon initial prostatic biopsy who had subsequent prostatic biopsies. The meantime of follow-up was 17.3 months (range 1–62). The mean number of biopsy sessions was 2.5 (range 2–6), and the median number of biopsy cores was10 (range 6–14).Results: On subsequent biopsies, the rate of prostate cancer was 21.9% (44/201)in HGPIN patients. Of these, 32/201 patients (15.9%), 9/66 patients (13.6%)and 3/18 patients (16.6%) were found to have cancer on the first, second and third follow-up biopsy sessions, respectively. In ASAP patients, the cancer detectionrate was 13/22 (59.1%), all of whom were found on the first follow-upbiopsy. There was a statistically significant difference between the cancer detectionrate in ASAP and HGPIN patients (p < 0.001). Multivariate analysis showedthat the independent predictors of cancer were the number of cores in theinitial biopsy, the number of cores (> 10) in the follow-up biopsy and a prostate specific antigen (PSA) density of ≥ 0.15 (odds ratio 0.77, 3.46 and 2.7,8 respectively;p < 0.04). Conversely, in ASAP patients none of these variables werefound to be associated with cancer diagnosis.Conclusion: ASAP is a strong predictive factor associated with cancer when comparedwith HGPIN. The factors predictive of cancer on follow-up biopsy ofHGPIN are number of cores on initial biopsy, more than 10 cores in rebiopsyand elevated PSA density. As the cancer detection rate on repeated biopsy of HGPIN patients is the same as that of patients without HGPIN, perhaps the standard of repeat biopsy in all patients with HGPIN should be revisited.

Evaluating the impact of African American ancestry among men with localized prostate cancer treated with radical prostatectomy.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 41-41
Author(s):  
Daniel Canter ◽  
Julia E. Reid ◽  
Maria Latsis ◽  
Margaret Variano ◽  
Shams Halat ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
African American ◽  
Radical Prostatectomy ◽  
Gleason Score ◽  
Metastatic Disease ◽  
Proportional Hazards ◽  
Clinical Stage ◽  
Cox Proportional Hazards ◽  
Significant Difference ◽  
The Impact

41 Background: Prostate cancer (PC) is the most common male malignancy. Prior data has suggested that African American (AA) men present with more aggressive disease relative to men of other ancestries. Here, we examined the effects of ancestry on clinical and molecular measures of disease aggressiveness as well as pathologic outcomes in men treated with radical prostatectomy (RP) for localized PC. Methods: Data was collected from patients undergoing RP at the Ochsner Clinic from 2006 to 2011. Formalin−fixed paraffin embedded biopsy tissue was analyzed for the RNA expression of 31 cell cycle progression (CCP) genes and 15 housekeeping genes to obtain a CCP score (a validated molecular measure of PC aggressiveness). Cancer of the Prostate Risk Assessment (CAPRA) scores were also determined based on clinicopathologic features at the time of diagnosis. Clinical (Gleason score, tumor stage, CAPRA score) and molecular (CCP score) measures of disease aggressiveness were compared based on ancestry (AA versus non−AA). Cox proportional hazards models were used to test association of ancestry to biochemical recurrence (BCR) and progression to metastatic disease. Fisher’s exact and Wilcoxon rank sum tests were used to compare ancestries. Results: A total of 384 patients were treated with RP, including 133 (34.8%) AA men. At the time of diagnosis, the median age was 62 years (interquartile range (IQR) 56, 66) and PSA was 5.4 ng/mL (IQR 4.2, 7.6). When compared by ancestry, there were no significant differences in biopsy Gleason score (p = 0.26), clinical stage (p = 0.27), CAPRA score (p = 0.58), or CCP score (p = 0.87). In addition, there was no significant difference in the risk of BCR between ancestries (p = 0.55). Only non−AA men progressed to metastatic disease within the ten years of follow−up. Conclusions: Contrary to prior reports, these data appears to indicate that men of AA ancestry do not necessarily present with or develop a more biologically aggressive form of PC. Although these data represents only one institution’s experience, it contains a highly robust AA population compared to prior reports. Further research is required to account for the discrepancy in the previously published literature.

Preliminary Results of a Randomized Radiotherapy Dose-Escalation Study Comparing 70 Gy With 78 Gy for Prostate Cancer

2000 ◽  
Vol 18 (23) ◽  
pp. 3904-3911 ◽  
Author(s):  
Alan Pollack ◽  
Gunar K. Zagars ◽  
Lewis G. Smith ◽  
J. Jack Lee ◽  
Andrew C. von Eschenbach ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Dose Escalation ◽  
Proportional Hazards ◽  
External Beam Radiotherapy ◽  
Specific Antigen ◽  
Cox Proportional Hazards ◽  
Phase Iii ◽  
Dose Escalation Study ◽  
Radiotherapy Dose

PURPOSE: To determine the effect of radiotherapy dose on prostate cancer patient outcome and biopsy positivity in a phase III trial. PATIENTS AND METHODS: A total of 305 stage T1 through T3 patients were randomized to receive 70 Gy or 78 Gy of external-beam radiotherapy between 1993 and 1998. Of these, 301 were assessable; stratification was based on pretreatment prostate-specific antigen level (PSA). Dose was prescribed to the isocenter at 2 Gy per fraction. All patients underwent planning pelvic computed tomography scan to confirm prostate position. Treatment failure was defined as an increasing PSA on three consecutive follow-up visits or the initiation of salvage treatment. Median follow-up was 40 months. RESULTS: One hundred fifty patients were randomized to the 70-Gy arm and 151 to the 78-Gy arm. The difference in freedom from biochemical and/or disease failure (FFF) rates of 69% and 79% for the 70-Gy and 78-Gy groups, respectively, at 5 years was marginally significant (log-rank P = .058). Multiple-covariate Cox proportional hazards regression showed that the study randomization was an independent correlate of FFF, along with pretreatment PSA, Gleason score, and stage. The patients who benefited most from the 8-Gy dose escalation were those with a pretreatment PSA of more than 10 ng/mL; 5-year FFF rates were 48% and 75% (P = .011) for the 70-Gy and 78-Gy arms, respectively. There was no difference between the arms (∼80% 5-year FFF) when the pretreatment PSA was ≤ 10 ng/mL. CONCLUSION: A modest dose increase of 8 Gy using conformal radiotherapy resulted in a substantial improvement in prostate cancer FFF rates for patients with a pretreatment PSA of more than 10 ng/mL. These findings document that local persistence of prostate cancer in intermediate- to high-risk patients is a major problem when doses of 70 Gy or less are used.

Clonal hematopoiesis in prostate cancer inferred from somatic tumor profiling.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e17001-e17001
Author(s):  
Catherine Handy Marshall ◽  
Albert E Holler ◽  
Hua-Ling Tsai ◽  
Lukasz Gondek ◽  
Jun Luo ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Proportional Hazards ◽  
Somatic Tissue ◽  
Cox Proportional Hazards ◽  
Categorical Variables ◽  
Prognostic Impact ◽  
Liquid Biopsies ◽  
Tumor Biopsy ◽  
Clonal Hematopoiesis ◽  
Tumor Profiling

e17001 Background: Clonal hematopoiesis (CH) is a process associated with normal aging and may complicate the interpretation of liquid-biopsy genomic testing in oncology. Little is known about the prevalence of CH in prostate cancer as detected on somatic tumor profiling, or its association with clinical parameters and outcomes in prostate cancer. We sought to estimate the prevalence and clinical characteristics of patients with CH identified from tissue-based prostate cancer specimens. Methods: This was a retrospective study of men with prostate adenocarcinoma who underwent clinical somatic tissue-based next-generation sequencing using commercial platforms (n = 364). Patients with known hematologic malignancies (n = 7), and those with only liquid biopsies were excluded (n = 34), leaving 323 cases. Classical CH mutations were defined as those in DNMT3A, TET2 or ASXL1. Additional CH mutations included were defined as those in BCORL1, GNAS, SF3B1, JAK2 or PPM1D. Chi-squared tests were used to compare prevalence by categorical variables, Kruskal-Wallis tests to compare means across groups, and Cox proportional hazards were used for time-to-event analyses. Results: The prevalence of CH mutations in prostate cancer was 9% (30/323), and the prevalence of classical CH mutations was 7% (22/323)(Table). The most common mutations were in DNMT3A (n = 9), TET2 (n = 8) and ASXL1 (n = 5); other less common CH alterations were in GNAS and SF3B1 (n = 3 each), followed by CBL and JAK2 (n = 1 each). The most common site of tumor biopsy was the prostate (N = 266) followed by visceral (n = 19) and lymph node (N = 19) metastases. Men with any CH mutation were not significantly older at age of prostate cancer diagnosis (64 vs 62 years; p = 0.19) than those without; however, men with classical CH mutations were statistically older at diagnosis than those without (66 vs 62 years; p = 0.04). There was no difference in prevalence of CH mutations by Gleason sum (P = 0.67). Among men with localized disease at diagnosis, the median metastasis-free survival was 3.9 years in those with overall CH mutations and 6.6 years in those without CH mutations (HR [adjusted for age and Gleason] 1.3; 95% CI 0.7-2.3; p = 0.4). OS from the time of diagnosis to death was also numerically shorter in those with any CH mutation (median 9.7 years in those with and 14.2 years in those without CH mutations; HR 1.2, 95% CI 0.6-2.5; p = 0.6). Conclusions: CH can be detected in about 7-9% of prostate cancer patients from tissue-based tumor samples, is associated with older age, and may be linked to adverse oncological outcomes. The prognostic impact of CH in the context of specific systemic therapies (hormonal, chemotherapeutic) remains to be elucidated.[Table: see text]

Impact of proximity to NCI- and NCCN-designated cancer centers on outcomes for patients with prostate cancer undergoing radical prostatectomy.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 14-14 ◽  
Author(s):  
Cameron Ghaffary ◽  
Tamer Dafashy ◽  
Christopher David Kosarek ◽  
Zhigang Duan ◽  
Brian F. Chapin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Radical Prostatectomy ◽  
Proportional Hazards ◽  
Clinical Stage ◽  
Cox Proportional Hazards ◽  
Survival Outcomes ◽  
Cancer Centers ◽  
Cox Proportional Hazards Models ◽  
Significant Difference

14 Background: National Cancer Institute (NCI) and National Comprehensive Cancer Network (NCCN)-designated cancer centers (CCs) offer patients state-of-the-art treatment. We sought to identify whether proximity to NCI/NCCN CCs was associated with survival outcomes for prostate cancer patients who undergo radical prostatectomy (RP). Methods: A total of 12,478 total patients diagnosed with clinical stage T1 or T2 prostate cancer between 2004–2011 using linked Surveillance, Epidemiology, and End Results (SEER)-Medicare data were included. Multivariable regression analyses were used to quantify overall survival and use of secondary therapies for RP patients according to proximity to NCI/NCCN CCs. Cox proportional hazards models were used to quantify the association between survival outcomes and access to NCI/NCCN CCs. Results: Patients with proximity to ≥ 2 NCI centers and those diagnosed in 2011 enjoyed a statistically significant overall survival advantage when compared to no access to an NCI center (Hazard Ratio (HR) 0.72; 95% confidence interval (CI) 0.57–0.92, p < 0.01). Proximity to an NCCN CC, when compared with men who did not have access, was associated with improved overall survival (HR 0.76; 95% CI 0.61–0.95, p = 0.015). There was no significant difference in use of secondary therapies according to NCI or NCCN access. Conclusions: Patients who undergo RP with access to an NCI/NCCN CCs experienced improved overall survival with no significant difference in utilization of secondary therapies. Given the need for improved health quality measures in cancer care, these findings may support health policy implementation and regionalization of care to these centers.

Improving risk-stratification of localized prostate cancer in a prospective active surveillance cohort.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 104-104
Author(s):  
Justin Gregg ◽  
Chad A. Reichard ◽  
Xuemei Wang ◽  
Brian Francis Chapin ◽  
Louis L. Pisters ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Stratification ◽  
Active Surveillance ◽  
Proportional Hazards ◽  
Specific Antigen ◽  
Cox Proportional Hazards ◽  
Tumor Length ◽  
Improve Risk Stratification ◽  
Optimal Monitoring ◽  
Significant Difference

104 Background: Prospective active surveillance (AS) studies in men with low- and intermediate-risk prostate cancer (PCa) have demonstrated feasibility, but no consensus supports an optimal monitoring scheme. To expand our findings on AS disease reclassification, we examined predictors of disease reclassification in a prospective single-institution AS study. Methods: Men with localized PCa diagnosed within 6 months (mos) of AS enrollment were stratified into four groups: group 1 (Gr 1) was defined by a Gleason score (GS) ≤6 (3+3), one positive (pos) core ( < 3 mm), and a prostate-specific antigen (PSA) level < 4 ng/mL (adjusted by prostate size); Gr IIa by GS 6, one pos core, and either tumor length ≥3 mm or PSA ≥4 ng/mL; Gr IIb by GS6, > one pos core, and any PSA level or tumor length; Gr IIc by GS7, > one pos core or any PSA. Monitoring included PSA and digital rectal exam every 6 mo. Biopsy (BX) was repeated at 1 year and then on a predetermined BX scheme. Patients with reclassified disease (upgrading, increase in pos cores and/or tumor length) were offered treatment. Cox proportional hazards modeling was used to determine the association of baseline clinicopathologic parameters with time to reclassification. Results: Between 2006 and 2015, 803 patients met criteria for inclusion: Gr I, 242; Gr IIa, 67; Gr IIb, 376; Gr IIc, 118. Median age was 64 years (range, 36–83), 662 (82.4%) were white, 703 (87.5%) had cT1c disease, 687 (85.6%) had GS 6, and median PSA level was 4.2 ng/mL (range 0.2–34). At a median follow-up of 2.9 years, 249 (31.0%) men had disease reclassification and 258 (32.1%) left AS to pursue curative treatment. Overall, 82% of reclassifications occurred within 3 years of study enrollment. Stratification to group IIb/IIc was significantly associated with time to reclassification compared to Gr I/IIa (HR 2.13, 95 CI 1.63-2.80, p < 0.001) while CAPRA score did not show a significant difference (p = 0.27). Conclusions: Grouping patients on characteristics including tumor length and pos core number may improve risk stratification in localized PCa. Risk-based surveillance protocols merit further evaluation. Clinical trial information: NCT00490763.

A 17-gene genomic prostate score as a predictor of adverse pathology for men on active surveillance.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 97-97
Author(s):  
Zachary Kornberg ◽  
Matthew R. Cooperberg ◽  
Janet E. Cowan ◽  
Jeffry Simko ◽  
June M. Chan ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Median Time ◽  
Active Surveillance ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Low Risk ◽  
Cox Proportional Hazards Regression ◽  
Proportional Hazards Regression ◽  
Increased Risk ◽  
Short Period

97 Background: The OncotypeDX Genomic Prostate Score (GPS) test is a RNA expression assay that can be performed on needle-core biopsies from men with prostate cancer (PCa). GPS has previously been validated as a predictor of adverse pathology in men with low-risk prostate cancer who undergo primary radical prostatectomy (RP). We sought to determine whether GPS was associated with increased risk of adverse pathology for men enrolled on active surveillance (AS) who undergo delayed RP. Methods: Of 1,662 men enrolled on AS at the University of California San Francisco (UCSF) who consented for prospective data collection, we evaluated 215 men on AS with Gleason score (GS) 3+3 and GS 3+4 PCa who underwent GPS testing at diagnostic or confirmatory biopsy (ie. within 1 year). Patients had at least 6 biopsy cores sampled and ≤ 33% positive cores, stage T1 or T2 disease, PSA < 20, and clinical Cancer of the Prostate Risk Assessment (CAPRA) score < 6. The primary outcome was adverse pathology at delayed RP, defined as GS ≥ 4+3, stage ≥ pT3a or pN1. We performed Cox proportional hazards regression, and inverse probability censored weights (IPCW) models to evaluate association between GPS and adverse pathology, adjusting for CAPRA score. Results: 72 percent (N=154) of the cohort had GS 3+3, and 28 percent (N=61) had GS 3+4. 83 percent of men (N=179) were low risk, and 17 percent of men (N=36) were intermediate risk by CAPRA scoring. Median GPS was 26.4 (interquartile range [IQR]: 18.8, 34.6). Median time from diagnosis to RP was 23 months (IQR: 15, 40). 121 men had adverse pathology on delayed RP at a median time of 27 months (IQR 16, 43) to prostatectomy. In a Cox-proportional hazards regression adjusted for CAPRA, GPS was associated with increased risk of adverse pathology at delayed RP (Hazard Ratio [HR] per 5 units: 1.12, 95 Confidence Interval [CI]: 1.05, 1.20, p < 0.01). CAPRA score was not associated with adverse pathology (p=0.09). IPCW model findings were very similar to Cox results. Conclusions: In patients who undergo RP after a relatively short period of AS, a higher GPS is associated with increased risk for adverse pathology on delayed RP.

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