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.

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.

Can PSA doubling time exactly predict the candidates for active surveillance in patients with low-risk prostate cancer?

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 65-65
Author(s):  
Satoru Maruyama ◽  
Nobuo Shinohara ◽  
Takashige Abe ◽  
Ataru Sazawa ◽  
Katsuya Nonomura
Keyword(s):  
Prostate Cancer ◽  
Risk Factors ◽  
Active Surveillance ◽  
Doubling Time ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Biochemical Relapse ◽  
Free Survival ◽  
Risk Prostate Cancer ◽  
Low Risk Prostate Cancer

65 Background: Currently, there are few well-validated data of PSA kinetics (PSA doubling time [PSADT] and PSA velocity) in active surveillance protocols. The objective of the study was to elucidate whether PSADT could predict patients with low-risk prostate cancer suitable for active surveillance (AS). Methods: The study included 149 consecutive patients treated with radical prostatectomy (RP). We selected patients who could be candidates for AS (PSA≤10ng/ml and Gleason score (GS)≤3+3 and cT1-2N0M0). PSA had been measured two times at least in a year before surgery. After all, from April 2000 to March 2008, we retrospectively reviewed a total of 47 patients (median age were 64 years, range: 53-75). Patients were divided into the following two groups: patients whose PSADT<36 months (Rapid group) and the others (Non-rapid group). We determined the respective rates of upgrading, upstaging and biochemical relapse-free survival (bRFS) in each group. Risk factors were evaluated using a Cox proportional hazards model. Results: In the whole specimen of 47 pts, upgraded to Gleason score 7-8, extracapsular extension (ECE: pT3a disease), seminal vesicle involvement and upstaged were 23 (49%), 7 (15%), none (0%) and 7 (15%), respectively. No statistical significance was observed in occurrence rates of upgrading and upstaging between Rapid group (56%, 19%) and Non-rapid group (45%, 13%). There was no significant difference in biochemical-free survival rates in two groups (5-year bRFS were 71% and 77%, respectively). The Cox proportional hazards analysis demonstrated that any pre-operative factors including PSADT were not significant risk factors for biochemical relapse. Conclusions: Our findings revealed that pre-opeative PSADT did not reliably predict pathology and prognosis after RP in those who were candidates for AS. PSADT is not suitable for selection criteria and for monitoring on active surveillance.

scholarly journals Event-Free Survival after 68Ga-PSMA-11 PET/CT in recurrent Hormone-Sensitive Prostate Cancer (HSPC) patients eligible for Salvage Therapy.

2021 ◽  
Author(s):  
Francesco Ceci ◽  
Guido Rovera ◽  
Giuseppe Carlo Iorio ◽  
Alessia Guarneri ◽  
Valeria Chiofalo ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Salvage Therapy ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Event Free Survival ◽  
Free Survival ◽  
Kaplan Meier ◽  
Psma Pet ◽  
Hormone Sensitive

Abstract Background/AimProstate-Specific-Membrane-Antigen/Positron Emission Tomography (PSMA-PET) detects with high accuracy disease-recurrence, leading to changes in the management of biochemically-recurrent (BCR) prostate cancer (PCa). However, data regarding the oncological outcomes of patients who performed PSMA-PET are needed. The aim of this study was to evaluate the incidence of clinically-relevant events during follow-up in patients who performed PSMA-PET for BCR after radical treatment. Materials and Methodsthis analysis included consecutive, hormone-sensitive, hormone-free, recurrent PCa patients (HSPC) enrolled through a prospective study. All patients were eligible for salvage therapy, having at least 24 months of follow-up after PSMA-PET. The primary endpoint was the Event-Free Survival (EFS), defined as the time between the PSMA-PET and the date of event/last follow-up. The Kaplan-Meier method was used to estimate the EFS curves. EFS was also investigated by Cox proportional hazards regression. Events were defined as: death, radiological progression or PSA recurrence after therapy. ResultsOne-hundred and seventy-six (n=176) patients were analyzed (median PSA 0.62 [IQR:0.43–1.00] ng/mL; median follow-up of 35.4 [IQR:26.5-40.3] months). The EFS was 78.8% at one year, 65.2% (2-years), and 52.2% (3-years). Patients with clinically relevant events had a significantly higher median PSA (0.81 [IQR:0.53-1.28] vs 0.51 [IQR:0.36-0.80] ng/mL) and a lower PSAdt (5.4 [IQR:3.7-11.6] vs 12.7 [IQR:6.6-24.3] months) (p<0,001) compared to event-free patients. The Kaplan-Meier curves showed that PSA>0.5 ng/mL, PSAdt≤6 months and a positive PSMA-PET result were associated with a higher event rate (p<0.01). No significant differences of event rates were observed in patients who received changes in therapy management after PSMA-PET vs. patients who did not receive therapy changes. Finally, PSA> 0.5 ng/mL and PSAdt≤ 6months were statistically significant event-predictors in multi-variate model (p<0.001). ConclusionIn this cohort of HSPC patients prospectively enrolled, low PSA and long PSAdt were significant predictors of event. Furthermore, a lower incidence of events was observed also in patients having negative PSMA-PET, since longer EFS was significantly more probable in case of a negative scan.

Adjuvant versus neoadjuvant androgen deprivation with radiation therapy for prostate cancer: Does sequencing matter?

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 37-37 ◽  
Author(s):  
Michael A. Weller ◽  
Rahul D. Tendulkar ◽  
Chandana A. Reddy ◽  
Kevin L. Stephans ◽  
Patrick Kupelian
Keyword(s):  
Prostate Cancer ◽  
Radiation Therapy ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Androgen Deprivation ◽  
Free Survival ◽  
Entire Cohort ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer ◽  
The Impact

37 Background: Androgen deprivation therapy (ADT) is typically given neoadjuvantly and concurrently with radiation therapy (RT) rather than adjuvantly in the management of intermediate and high risk prostate cancer. Our objective is to compare outcomes between patients who receive adjuvant ADT (ADJ), i.e. immediately after the completion of RT, with those who receive a neoadjuvant and concurrent regimen (NEO). Methods: From 1995-2002, 515 patients with CaP were definitively treated with RT and ADT. ADT was given for a duration of 6 months in all cases. NEO was given 2-3 months prior to the start of RT. ADJ was initiated immediately following the completion of RT. ADT sequencing was NEO in 311 (60%) and ADJ in 204 (40%). The distribution by NCCN risk classification for NEO was high in 67%, intermediate in 26%, and low in 7%. The risk group distribution for ADJ was high in 69%, and intermediate in 31%. RT dose was either 78 Gy at 2 Gy/fx (n=168) or 70 Gy at 2.5 Gy/fx (n=347). Kaplan-Meier analysis was used to calculate biochemical relapse free survival (bRFS, Phoenix definition), distant metastasis free survival (DMFS) and overall survival (OS). Cox proportional hazards regression was used to examine the impact of ADT timing on outcomes. Results: The median follow up for all patients was 8 years. For the entire cohort, the 10-yr bRFS, DMFS and OS rates were 61%, 80% and 66%, respectively. The 10-yr bRFS rates for ADJ vs. NEO were 63% vs. 60% (p=0.98). The 10-yr DMFS rates for ADJ vs. NEO were both 80% (p=0.60). The 10-yr OS rates for ADJ vs. NEO were 65% vs. 67% (p=0.98). There were no statistically significant differences in bRFS, DMFS or OS between the two groups after accounting for patient, tumor and treatment characteristics on both univariate and multivariate analyses. Conclusions: There is no difference between neoadjuvant vs. adjuvant ADT in the setting of dose-escalated RT for localized prostate cancer. This suggests that the synergy between radiation therapy and androgen deprivation is independent of the sequencing of both modalities and that the initiation of RT does not need to be delayed for a course of neoadjuvant ADT.

scholarly journals Risk and Timing of Cardiovascular Disease After Androgen-Deprivation Therapy in Men With Prostate Cancer

2015 ◽  
Vol 33 (11) ◽  
pp. 1243-1251 ◽  
Author(s):  
Sean O'Farrell ◽  
Hans Garmo ◽  
Lars Holmberg ◽  
Jan Adolfsson ◽  
Pär Stattin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cardiovascular Disease ◽  
Androgen Deprivation Therapy ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Androgen Deprivation ◽  
Gnrh Agonists ◽  
Cvd Risk ◽  
Comparison Cohort ◽  
Using Data

Purpose Findings on the association between risk of cardiovascular disease (CVD) and the duration and type of androgen-deprivation therapy (ADT) in men with prostate cancer (PCa) are inconsistent. Methods By using data on filled drug prescriptions in Swedish national health care registers, we investigated the risk of CVD in a cohort of 41,362 men with PCa on ADT compared with an age-matched, PCa-free comparison cohort (n = 187,785) by use of multivariable Cox proportional hazards regression models. Results From 2006 to 2012, 10,656 men were on antiandrogens (AA), 26,959 were on gonadotropin-releasing hormone (GnRH) agonists, and 3,747 underwent surgical orchiectomy. CVD risk was increased in men on GnRH agonists compared with the comparison cohort (hazard ratio [HR] of incident CVD, 1.21; 95% CI, 1.18 to 1.25; and orchiectomy: HR, 1.16; 95% CI, 1.08 to 1.25). Men with PCa on AA were at decreased risk (HR of incident CVD, 0.87; 95% CI, 0.82 to 0.91). CVD risk was highest during the first 6 months of ADT in men who experienced two or more cardiovascular events before therapy, with an HR of CVD during the first 6 months of GnRH agonist therapy of 1.91 (95% CI, 1.66 to 2.20), an HR of CVD with AA of 1.60 (95% CI, 1.24 to 2.06), and an HR of CVD with orchiectomy of 1.79 (95% CI, 1.16 to 2.76) versus the comparison cohort. Conclusion Our results support that there should be a solid indication for ADT in men with PCa so that benefit outweighs potential harm; this is of particular importance among men with a recent history of CVD.

scholarly journals Treatment outcomes of 125I low-dose-rate brachytherapy vs radical prostatectomy for patients with intermediate-risk prostate cancer

2020 ◽  
Author(s):  
Zhien Zhou ◽  
Meiting He ◽  
Yi Zhou ◽  
Weigang Yan ◽  
Xingcheng Wu ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Radical Prostatectomy ◽  
Dose Rate ◽  
Low Dose ◽  
Intermediate Risk ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Low Dose Rate ◽  
Risk Prostate Cancer ◽  
Low Dose Rate Brachytherapy

Abstract Background: Radical prostatectomy (RP) and low-dose-rate brachytherapy (LDR) are two widely used treatment options for patients with intermediate-risk prostate cancer (IRPC). However, which one is better remains controversial. Therefore, the purpose of this study was to compare the efficacy of RP vs LDR for patients with IRPC. Methods: A retrospective analysis was performed on 361 IRPC patients who underwent treatment from January 2010 and August 2017. 160 underwent RP and 201 underwent LDR using Iodine-125. Biochemical failure for RP was defined as prostate-specific antigen (PSA) levels > 0.2 ng/ml, and for LDR as nadir PSA level + 2 ng/ml. The log-rank test compared biochemical relapse-free survival (bRFS) between the two modalities, and Cox regression identified factors associated with bRFS. Results: Median follow-up was 54 months for RP and 69 months for LDR. The 5-and 8-year bRFS rates were 70.2% and 63.1% in the RP group, and 83.2% and 68.9% in the LDR group, respectively, P=0.003. There were no significant differences in terms of clinical relapse-free survival (cRFS), cancer-specific survival (CSS) or overall survival (OS) between the two groups. Conclusion: LDR is a reasonable treatment option for IRPC patients, yielding improved bRFS and equivalent rates of cRFS, CSS and OS compared with RP.

Focal Cryotherapy for Clinically Unilateral, Low-Intermediate Risk Prostate Cancer in 73 Men with a Median Follow-Up of 3.7 Years

2012 ◽  
Vol 62 (1) ◽  
pp. 55-63 ◽  
Author(s):  
Duke Bahn ◽  
Andre Luis de Castro Abreu ◽  
Inderbir S. Gill ◽  
Andrew J. Hung ◽  
Paul Silverman ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Intermediate Risk ◽  
Risk Prostate Cancer
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