Active Surveillance for Incidental (cT1a/b) Prostate Cancer: Long-Term Outcomes of the Prospective Noninterventional HAROW Study

2021 ◽  
pp. 1-8
Author(s):  
Jan Herden ◽  
Andreas Schwarte ◽  
Edith A. Boedefeld ◽  
Lothar Weissbach
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Multivariable Analysis ◽  
Low Risk ◽  
Long Term Outcomes ◽  
Invasive Treatment ◽  
Incidental Prostate Cancer ◽  
Free Survival

<b><i>Introduction:</i></b> Optimal treatment for incidental prostate cancer (IPC) after surgical treatment for benign prostate obstruction is still debatable. We report on long-term outcomes of IPC patients managed with active surveillance (AS) in a German multicenter study. <b><i>Methods:</i></b> HAROW (2008–2013) was designed as a noninterventional, prospective, health-service research study for patients with localized prostate cancer (≤cT2), including patients with IPC (cT1a/b). A follow-up examination of all patients treated with AS was carried out. Overall, cancer-specific, and metastasis-free survival and discontinuation rates were determined. <b><i>Results:</i></b> Of 210 IPC patients, 68 opted for AS and were available for evaluation. Fifty-four patients had cT1a category and 14 cT1b category. Median follow-up was 7.7 years (IQR: 5.7–9.1). Eight patients died of which 6 were still under AS or watchful waiting (WW). No PCa-specific death could be observed. One patient developed metastasis. Twenty-three patients (33.8%) discontinued AS changing to invasive treatment: 12 chose radical prostatectomy, 7 radiotherapy, and 4 hormonal treatment. Another 19 patients switched to WW. The Kaplan-Meier estimated 10-year overall, cancer-specific, metastasis-free, and intervention-free survival was 83.8% (95% CI: 72.2–95.3), 100%, 98.4% (95% CI: 95.3–99.9), and 61.0% (95% CI: 47.7–74.3), respectively. In multivariable analysis, age (RR: 0.97; <i>p</i> &#x3c; 0.001), PSA density ≥0.2 ng/mL<sup>2</sup> (RR: 13.23; <i>p</i> &#x3c; 0.001), and PSA ≥1.0 ng/mL after surgery (RR: 5.19; <i>p</i> = 0.016) were significantly predictive for receiving an invasive treatment. <b><i>Conclusion:</i></b> In comparison with other AS series with a general low-risk prostate cancer population, our study confirmed the promising survival outcomes for IPC patients, whereas discontinuation rates seem to be lower for IPC. Thus, IPC patients at low risk of progression may be good candidates for AS.

scholarly journals Long-term outcomes of active surveillance for clinically localized prostate cancer in a community-based setting: results from a prospective non-interventional study

2020 ◽  
Author(s):  
Jan Herden ◽  
Andreas Schwarte ◽  
Thorsten Werner ◽  
Uwe Behrendt ◽  
Axel Heidenreich ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Treatment Option ◽  
Localized Prostate Cancer ◽  
Daily Routine ◽  
Long Term Outcomes ◽  
Invasive Treatment ◽  
Free Survival

Abstract Purpose To report on long-term outcomes of patients treated with active surveillance (AS) for localized prostate cancer (PCa) in the daily routine setting. Methods HAROW (2008–2013) was a non-interventional, health service research study about the management of localized PCa in the community setting, with 86% of the study centers being office-based urologists. A follow-up examination of all patients who opted for AS as primary treatment was carried out. Overall, cancer-specific, and metastasis-free survival, as well as discontinuation rates, were determined. Results Of 329 patients, 62.9% had very-low- and 21.3% low-risk tumours. The median follow-up was 7.7 years (IQR 4.7–9.1). Twenty-eight patients (8.5%) died unrelated to PCa, of whom 19 were under AS or watchful waiting (WW). Additionally, seven patients (2.1%) developed metastasis. The estimated 10-year overall and metastasis-free survival was 86% (95% CI 81.7–90.3) and 97% (95% CI 94.6–99.3), respectively. One hundred eighty-seven patients (56.8%) discontinued AS changing to invasive treatment: 104 radical prostatectomies (RP), 55 radiotherapies (RT), and 28 hormonal treatments (HT). Another 50 patients switched to WW. Finally, 37.4% remained alive without invasive therapy (22.2% AS and 15.2% WW). Intervention-free survival differed between the risk groups: 47.8% in the very-low-, 33.8% in the low- and 34.6% in the intermediate-/high-risk-group (p = 0.008). On multivariable analysis, PSA-density ≥ 0.2 ng/ml2 was significantly predictive for receiving invasive treatment (HR 2.55; p = 0.001). Conclusion Even in routine care, AS can be considered a safe treatment option. Our results might encourage office-based urologists regarding the implementation of AS and to counteract possible concerns against this treatment option.

Gleason upgrading with time in a large, active surveillance cohort with long-term follow-up.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 1-1 ◽  
Author(s):  
Suneil Jain ◽  
Danny Vesprini ◽  
Alexandre Mamedov ◽  
D. Andrew Loblaw ◽  
Laurence Klotz
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Linear Regression Analysis ◽  
Low Risk ◽  
Disease Rate ◽  
Intermediate Risk ◽  
Rate Of Increase ◽  
Long Term Follow Up

1 Background: Active surveillance (AS) is an accepted management strategy for localized prostate cancer. However, the rate of pathological upgrading has not been well described in mature study cohorts. Furthermore, concern exists over the possibility of prostate cancer dedifferentiation with time in patients on AS. Methods: Patients in our prospectively collected AS database with at least one repeat prostate biopsy were included. Linear regression analysis was used to estimate the proportion of patients upgraded (Gleason 6 to 3+4 or higher, Gleason 3+4 to 4+3 or higher) with time from diagnostic biopsy. Results: 593 of 862 patients in our cohort had at least one repeat biopsy. Median follow-up was 6.4 years (max. 20.2 years). The total number of biopsies ranged from 2 to 6. 20% of patients were intermediate risk, 0.3 % high risk, all others low risk. 31.2% of patients were upgraded during active surveillance. The proportion of patients upgraded increased with time, suggesting prostate cancer dedifferentiation occurred at a rate of 1.0%/year (95%CI -0.12 to 2.16%/year). The estimated rate of increase was 2.5 times higher in patients with intermediate risk disease at diagnosis (rate 1.9%/year, 95%CI -0.7-4.6) compared with those with low risk disease (rate 0.75%/year, 95%CI -0.5-2.0). Further analysis is underway. 62% of upgraded patients (n=114) went on to have active treatment. Patients who were upgraded and treated had significantly greater PSA velocities (median 1.2 ng/ml/y vs 0.42 ng/ml/y, p=0.01) and significantly higher Gleason scores when upgraded, than those who remained on surveillance (21.8% vs 2.8% Gleason 8-10, p<0.01). Conclusions: This is the largest re-biopsy cohort, with long-term follow-up, described to date, enabling the first estimates of prostate cancer dedifferentiation in patients on AS. Dedifferentiation rates appear higher in patients with intermediate risk prostate cancer compared with those who are low risk at baseline.

Conditional progression-free survival in men on active surveillance for prostate cancer stratified by NCCN risk.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 222-222
Author(s):  
Andrew Gusev ◽  
Florian Rumpf ◽  
Keyan Salari ◽  
Jeffrey Twum-Ampofo ◽  
Matthew F Wszolek ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Progression Free Survival ◽  
Risk Groups ◽  
Low Risk ◽  
Conditional Survival ◽  
Free Survival ◽  
Kaplan Meier ◽  
Grade Progression

222 Background: Active surveillance (AS) is an accepted management strategy for men with very low, low, and select cases of favorable intermediate National Comprehensive Cancer Network (NCCN) risk prostate cancer (PCa). However, how patients’ risk of disease progression evolves over time during AS has not been well defined. Conditional survival measures the probability a patient will continue to survive some number of years, given that they have already survived a certain number without progression. We evaluated our AS cohort to investigate overall and conditional progression free survival on AS, stratified by the NCCN risk groups. Methods: We reviewed our institutional database of 1254 men enrolled in AS for localized PCa from 1996-2016. Our AS protocol includes prostate specific antigen (PSA) and digital rectal exam (DRE) every 4-6 months for 3 years, then annually. Mandatory confirmatory 12 core biopsy is done at 12-18 months. Multiparametric magnetic resonance imagining (mpMRI) or additional systematic or MRI-fusion biopsies are done at the discretion of physician and patient. Overall freedom from pathologic grade progression on follow-up biopsy and treatment free survival were estimated using the Kaplan-Meier method. Survival curves were compared pairwise using the Log-rank test and adjusted for false discovery rates with the Benjamini-Hochberg procedure. Three-year conditional survival estimates were derived for both outcomes from the Kaplan-Meier estimator. Results: Of 1254 men, 521 (41.6%) met criteria for very low, 606 (48.4%) for low, and 125 (10.0%) for favorable intermediate NCCN risk at diagnosis. Median follow-up time was 6.5 years (IQR 4.1-9.4). Median pathologic grade progression free survival in years was significantly longer for very low risk (7.8, 95% CI 6.8-11.2) compared to low risk men (5.6, 95% CI 4.7-6.9), however neither was significantly different from favorable intermediate risk men (5.9). There was no significant difference in treatment free survival between the three risk groups. At diagnosis, the three-year risk for pathologic grade progression (24%, 95% CI 21-27%) and progression to treatment (22%, 95% CI 20-25%) were similar. However, with increasing time of event-free AS, the conditional probability of pathologic grade progression increased, while that of progression to treatment decreased. Conclusions: Our results demonstrate that despite a mild increase in pathologic progression free survival in very low risk men, there was no clear difference in overall treatment free survival between very low, low, and select favorable intermediate NCCN risk men. Further, with increased time spent on AS, despite elevated rates of pathologic progression, patient progression to treatment decreased. This trend may be indicative of changes in goals of care as men with PCa age and should be closely monitored during AS.

scholarly journals MP48-12 ACTIVE SURVEILLANCE OF VERY LOW AND LOW RISK PROSTATE CANCER: LONG-TERM OUTCOMES FROM A LARGE PROSPECTIVE COHORT

2019 ◽  
Vol 201 (Supplement 4) ◽  
Author(s):  
Mufaddal Mamawala* ◽  
Jeffrey Tosoian ◽  
Jonathan Epstein ◽  
Patricia Landis ◽  
Demetrios Simopoulos ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Prospective Cohort ◽  
Low Risk ◽  
Long Term Outcomes ◽  
Risk Prostate Cancer ◽  
Low Risk Prostate Cancer ◽  
Large Prospective Cohort

Cautionary tale of active surveillance in intermediate-risk patients: Overall and cause-specific survival in the Sunnybrook experience.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 163-163 ◽  
Author(s):  
Hima Bindu Musunuru ◽  
Laurence Klotz ◽  
Danny Vespirini ◽  
Liying Zhang ◽  
Alexandre Mamedov ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Gleason Score ◽  
Low Risk ◽  
P Value ◽  
Intermediate Risk ◽  
Free Survival ◽  
Risk Patients ◽  
Cause Specific Survival

163 Background: To document the long-term outcomes of intermediate risk (IR) prostate cancer patients managed on active surveillance (AS) protocol in a single institute. Methods: Patients(pts) with PSA >10ng/ml or Gleason score 7 or clinical stage T2b/2c were identified from a prospectively collected database of 945 patients managed on AS between 1995 and 2013. Intervention was offered to those pts with a PSA doubling time of < 3 years, Gleason score or clinical progression.Overall survival (OS), cause-specific survival (CSS) for IR and low risk (LR) pts were analyzed as well as metastasis free survival (MFS) and treatment-free survival (TFS) for IR pts. Results: 237 (23.9%) pts had IR disease, with a median follow up of 6.9 years (IQR 3.89, 10.85) .708 pts had LR cancer with a median follow up of 6.4 years (IQR 3.76, 9.03). 61.2% of the IR cohort was older than 70 years. 86 IR pts (36.3%) received treatment (mainly radiation). The median treatment free interval for IR pts was 12.3 years (range 10.1 - 19.8). 33 IR patients developed biochemical failure and 17 developed metastatic disease [11 IR pts(4.6%) and 6 LR pts(0.8%)].The 10 and 15year OS was 68.4% and 50.3% for IR pts;83.6% and 68.8% for LR pts (p value <0.0001).Similarly 10 and 15 year CSS was 95.5% and 88.5% for IR ; 98.2% and 96.3% for LR pts (p value=0.006).The hazard ratio for IR pts versus LR pts was 2.08 for OS and 3.75 for CSS.IR pts had 3.75 times higher chance of dying from prostate cancer when compared to LR pts (Table). 10 year MFS and TFS were 92.1% (87.4-97.1%) and 58.5% (51.6-66.4%) in the IR cohort. Survival outcomes did not vary according to the year of patient enrollment. Conclusions: AS for intermediate risk prostate has significantly lower OS and CSS compared to low risk patients and therefore extreme caution should be exercised if it were to be implemented in intermediate risk patients. [Table: see text]

Long-term prospective health related quality of life (HRQoL) outcomes: Impact of active surveillance before treatment of low risk prostate cancer (PCa).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17518-e17518
Author(s):  
Nathan Jung ◽  
Jason Frankel ◽  
Galen Conti ◽  
Christopher Porter ◽  
John Paul Flores
Keyword(s):  
Prostate Cancer ◽  
Sexual Function ◽  
Physical Health ◽  
Active Surveillance ◽  
Low Risk ◽  
Definitive Treatment ◽  
Urinary Function ◽  
Over Time

e17518 Background: The treatment options for low risk PCa are active surveillance (AS), radiation therapy (RT), and radical prostatectomy (RP). HRQoL studies with long term follow up are lacking. We evaluated HRQoL of initial active surveillance vs initial treatment. Methods: The Center for Prostate Disease Research (CPDR) database was used. HRQoL data was collected for 5 years with the Expanded Prostate Cancer Index Composite (EPIC) and the 36-item Medical Outcomes Study Short Form (SF-36). Patients had low risk PCa, age less than 75, and follow up data of at least 1 year. AS was defined as no definitive treatment within 12 months of diagnosis and repeat biopsy or PSA within 18 months of diagnosis. Results: Patient characteristics are located in the table. Baseline HRQoL scores were comparable across treatment groups for all HRQoL domains, except for sexual function and bother, and physical health where RT were worse than RP. Of the 68 patients classified as AS, 4 had brachytherapy, 9 had hormone therapy, 38 had RP, and 17 had XRT as a first treatment after terminating their AS. In the Generalized Estimating Equations (GEE) model, the HRQoL scores were compared. Multivariate analysis was done accounting for baseline differences. Urinary function (p = 0.0017), urinary bother (p = 0.0028), hormone function (p = 0.035), bowel bother (p = 0.0122), sexual function (p < 0.01), sexual bother (p < 0.01), and physical health (p = 0.0457) were significantly different. For urinary function and bother, XRT had the best HRQoL scores at most time points, with AS getting worse over time as patients went on to receive treatment. AS had worse scores with hormone function and sexual function. RP had the best scores for bowel bother over the course of the study, but had the worst initial scores in sexual bother, which got better over time. Hormone bother (p = 0.5574), Bowel function (p = 0.098), mental health (p = 0.7231) were not statistically different between groups. Conclusions: Initially AS results in improved HRQoL. For those patients who undergo treatment after AS, HRQoL is no worse than those who got treatment initially. [Table: see text]

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.

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