959 HAROW - a prospective non-interventional study comparing treatment options in localized prostate cancer: Observation of “active surveillance” patients with a mean follow up of 47.6 months

2016 ◽  
Vol 15 (3) ◽  
pp. e959
Author(s):  
J. Herden ◽  
D. Schnell ◽  
L. Weissbach
2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 136-136 ◽  
Author(s):  
Erika L. Wood ◽  
Steven Canfield

136 Background: The standard of care for managing localized prostate cancer includes offering patients active surveillance. With the 10-year prostate cancer specific survival between 96-100% for both low and low-intermediate risk patients, active surveillance has proven to be a safe and effective option. Most studies have examined cohorts of patients within a tertiary referral center but data is sparse on county hospital patients, where health insurance coverage among other concerns pose barriers for patients to receive consistent medical care. We were interested in how active surveillance was performing amongst a cohort of county hospital based patients. Methods: A retrospective chart review was conducted on fifty patients placed on active surveillance for low and low-intermediate risk prostate cancer (by D’Amico criteria) between July 1, 2007 and August 1, 2013. Overall and cause-specific survival were the main outcome measures. Data was also collected on loss to follow-up rates. Results: In the cohort, the mean age at diagnosis was 62.2, mean body mass index was 28.0, most were African American or Hispanic (50% and 46%, respectively) and the majority had low-risk disease (84%). The median length of follow-up after diagnosis was 22 months. Nearly half of patients stopped active surveillance (44%), the most common reason being reclassification of their disease after second biopsy. All patients who were reclassified received definitive treatment with the exception of one patient who was lost to follow-up. Cause-specific and overall mortality were both 100% in this cohort. Nearly a quarter of patients (22%) were lost to follow-up (either had less than 12 months of surveillance following diagnosis or had not presented to clinic within the last 12 months). Conclusions: High rates of loss to follow-up present a significant challenge to managing localized prostate cancer with active surveillance in a county hospital population. In this small cohort, active surveillance appears to be a safe and effective management option for localized prostate cancer, yet undetected disease progression remains a significant concern.


2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 120-120
Author(s):  
Christopher Baker ◽  
Andrew M. McDonald ◽  
Grant Clark ◽  
Caleb Dulaney ◽  
Eddy Shih-Hsin Yang ◽  
...  

120 Background: There have been no prospective randomized controlled trials comparing current treatment options for patients with high-risk localized prostate cancer. This study seeks to compare the biochemical and metastatic outcomes of patients that received definitive radiotherapy (dRT) or radical prostatectomy (RP) for localized prostate cancer with Gleason score ≥ 8 on initial biopsy. Methods: A total of 106 patients met the inclusion criteria of Gleason score ≥ 8 on initial biopsy and biochemical follow-up ≥ 1 year. Seventy-one patients were initially treated with dRT (96% also receiving androgen deprivation therapy) and 35 patients were initially treated with RP (with or without postoperative RT). Our primary endpoint was biochemical failure (BF). For dRT patients, BF was recorded according to the Phoenix Consensus or if extranodal metastasis was diagnosed. For surgical patients, BF was recorded according to American Urological Association guidelines or if extranodal metastasis occurred. If adjuvant/salvage RT was given postoperatively, BF was recorded if PSA ≥ 0.5 on two consecutive measures after completion of RT. Pretreatment characteristics were compared using Pearson Chi-square method and independent samples Mann-Whitney U test. Actuarial rates of BF and metastasis were calculated using the Kaplan-Meier method. Results: Median follow-up for all patients was 5.3 years. There was no statistical difference in clinical T-stage, initial PSA, or months of follow up between patients treated initially with radiotherapy vs. prostatectomy. Patients initially treated with dRT were significantly older than those treated with RP. The dRT group had a lower rate of BF compared to the RP group, p < 0.001. The Kaplan-Meier estimate of BF at 5 years was 7.6% in the dRT group compared to 34.5% in the RP group. Additionally, the Kaplan-Meier estimate of distant metastasis at 10 years was 22.7% in the dRT group compared to 55.9% of the RP group, p = 0.01. Conclusions: For our sample of patients with Gleason score ≥ 8 on initial biopsy, initial treatment with dRT was associated with lower rates of biochemical failure and extranodal metastasis when compared to initial treatment with prostatectomy.


2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 42-42
Author(s):  
Ardalan Ahmad ◽  
Melvin Chua ◽  
Jure Murgic ◽  
Hamid Reza Raziee ◽  
Ali Hosni ◽  
...  

42 Background: To evaluate the oncologic outcomes and potential impact of delayed radical treatment in the form of radiotherapy (RT), in men with localized prostate cancer progressing after active surveillance (AS). Methods: We identified patients on AS subsequently treated with state-of-the-art RT (either dose-escalated image-guided intensity modulated radiotherapy [IG-IMRT] or low-dose-rate brachytherapy [LDR-BT]). Based on the clinical characteristics at time of AS progression, we compared the oncologic outcomes to matched patients treated with upfront RT after diagnose. One to two matching patients per AS case were identified from existing RT databases based on: age (+/- 3 years), clinical prognostic factors (NCCN risk group; PSA +/- 2ng/mL; cT category; primary and secondary Gleason score; percentage of diagnostic cores involved dichotomized at < or > 50%), and treatment modality (IG-IMRT or LDR-BT). We aimed to determine whether patients on AS have potentially compromised outcomes. Results: We identified 215 patients (out of 1070 AS cohort) undergoing RT after a median of 26 months (IQR 16-52.5) on AS. Median follow-up post RT was 4.8 years (IQR 2.9-7.2). No patient died of prostate cancer. At 5-years, the biochemical relapse free-, metastases free- and overall-survival rate were respectively 98.6%, 99.1%, 98.6% in the AS cohort. Matched cohort comprised 400 patients treated with IG-IMRT (71%) or LDR-BT (29%). Adequate matching was confirmed. The median follow-up post RT was 8.2 years (IQR 4.7-10). At 5-years, biochemical relapse free-, metastases free- and overall-survival rates of 98.5%, 98.7%, 93.7% respectively, which were not statistically different compared to those patients treated upon AS progression. Conclusions: Curative-intent radiotherapy (i.e. dose-escalated IG-IMRT or LDR-BT) after a period of AS renders excellent oncologic outcomes at 5 years. Moreover, the delay of therapy after a period of AS does not appear to result in inferior oncologic outcomes compared to patients with similar risk characteristics undergoing upfront radical radiotherapy.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16577-e16577
Author(s):  
Jan Herden ◽  
Dietrich Schnell ◽  
Axel Heidenreich ◽  
Lothar Weissbach

e16577 Background: Since more than half of patients with prostate cancer (PCa) are older than 70 years, this age group remains underrepresented in clinical trials. Possible non-invasive treatment options for these patients include Active Surveillance (AS) and Watchful Waiting (WW). In this prospective, non-interventional, health services research study, the use of different treatment options for localized PCa are observed under everyday conditions. The subgroups of patients ≥ 70 years, receiving AS- or WW are presented in terms of inclusion criteria, follow-up examinations and changes in treatment strategy. Methods: The study was conducted from July 2008 to July 2013 at 259 study centers in Germany, mainly office based urologists. The mean follow-up was 27.6 months. Clinical data (tumor category, digital rectal examination, PSA level, Gleason score, Charlson Comorbidity Index = CCI) and information about therapy and disease progression were collected at the time of study inclusion and subsequently at six-month intervals. According to the non-interventional study design, only recommendations were made for enrollment, course and discontinuation of AS and WW. The final therapeutic decision rested with treating physicians. Results: Overall, 2957 patients were enrolled, of whom 1165 were ≥ 70 years. 210 patients received AS and 87 patients received WW. AS patients were younger (73.9 vs. 76.8 years, p ≤ 0.001). The rate of low, intermediate and high risk tumors was 81.6%, 14.6% and 3.9% in the AS- and 39.1%, 43.5% and 17.4% in the WW-group (p ≤ 0.001). No differences were seen in the average number of PSA testing during the course of follow-up (AS = 3.97 vs WW = 3.79, p = 0.95). 37.6% of the AS patients and 12.4% of the WW patients received at least one follow-up biopsy. Conclusions: The results of HAROW indicate a clear distinction between AS and WW in terms of inclusion criteria. Interestingly, no clear distinction was seen in terms of follow-up examinations, since both groups were monitored frequently with PSA tests and even re-biopsies were performed in WW patients, neither of which is usually provided in WW programs.


2010 ◽  
Vol 28 (1) ◽  
pp. 126-131 ◽  
Author(s):  
Laurence Klotz ◽  
Liying Zhang ◽  
Adam Lam ◽  
Robert Nam ◽  
Alexandre Mamedov ◽  
...  

Purpose We assessed the outcome of a watchful-waiting protocol with selective delayed intervention by using clinical prostate-specific antigen (PSA), or histologic progression as treatment indications for clinically localized prostate cancer. Patients and Methods This was a prospective, single-arm, cohort study. Patients were managed with an initial expectant approach. Definitive intervention was offered to those patients with a PSA doubling time of less than 3 years, Gleason score progression (to 4 + 3 or greater), or unequivocal clinical progression. Survival analysis and Cox proportional hazard model were applied to the data. Results A total of 450 patients have been observed with active surveillance. Median follow-up was 6.8 years (range, 1 to 13 years). Overall survival was 78.6%. The 10-year prostate cancer actuarial survival was 97.2%. Overall, 30% of patients have been reclassified as higher risk and have been offered definitive therapy. Of 117 patients treated radically, the PSA failure rate was 50%, which was 13% of the total cohort. PSA doubling time of 3 years or less was associated with an 8.5-times higher risk of biochemical failure after definitive treatment compared with a doubling time of more than 3 years (P < .0001). The hazard ratio for nonprostate cancer to prostate cancer mortality was 18.6 at 10 years. Conclusion We observed a low rate of prostate cancer mortality. Among the patients who were reclassified as higher risk and who were treated, PSA failure was relatively common. Other-cause mortality accounted for almost all of the deaths. Additional studies are warranted to improve the identification of patients who harbor more aggressive disease despite favorable clinical parameters at diagnosis.


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