The purpose of this guideline is to provide a clinical framework for the use of radiotherapy after radical prostatectomy as adjuvant or salvage therapy.
Materials and methods:
A systematic literature review using the PubMed®, Embase, and Cochrane databases was conducted to identify peer-reviewed publications relevant to the use of radiotherapy after prostatectomy. The review yielded 294 articles; these publications were used to create the evidence-based guideline statements. Additional guidance is provided as Clinical Principles when insufficient evidence existed.
Guideline statements are provided for patient counseling, the use of radiotherapy in the adjuvant and salvage contexts, defining biochemical recurrence, and conducting a re-staging evaluation.
Physicians should offer adjuvant radiotherapy to patients with adverse pathologic findings at prostatectomy (i.e., seminal vesicle invasion, positive surgical margins, extraprostatic extension) and should offer salvage radiotherapy to patients with prostatic specific antigen or local recurrence after prostatectomy in whom there is no evidence of distant metastatic disease. The offer of radiotherapy should be made in the context of a thoughtful discussion of possible short- and long-term side effects of radiotherapy as well as the potential benefits of preventing recurrence. The decision to administer radiotherapy should be made by the patient and the multi-disciplinary treatment team with full consideration of the patient's history, values, preferences, quality of life, and functional status. Please visit the ASTRO and AUA websites (http://www.redjournal.org/webfiles/images/journals/rob/RAP%20Guideline.pdf and http://www.auanet.org/education/guidelines/radiation-after-prostatectomy.cfm) to view this guideline in its entirety, including the full literature review.
"In terms of efficacy, prognostic factors and toxicity, the two therapeutic strategies are used: immediate postoperative radiotherapy or adjuvant radiotherapy (ART) and delay postoperative radiotherapy or salvage radiotherapy (SRT) , . ART is the administration of radiotherapy post-prostatectomy to patients at a higher risk of recurrence due to APFs prior to evidence of disease recurrence, while SRT is the administration of radiotherapy to the prostatic bed and possibly to the surrounding tissues, including lymph nodes, in the patients with prostate specific antigen (PSA) recurrence after surgery but no evidence of distant metastatic disease , . Delivery of the ART or SRT becomes both therapeutic and diagnostic; PSA response indicates local persistence or recurrence , . "
[Show abstract][Hide abstract] ABSTRACT: Purpose
In men with adverse prognostic factors (APFs) after radical prostatectomy (RP), the most appropriate timing to administer radiotherapy remains a subject for debate. We conducted a systemic review and meta-analysis to evaluate the therapeutic strategies: adjuvant radiotherapy (ART) and salvage radiotherapy (SRT).
Materials and Methods
We comprehensively searched PubMed, EMBASE, Web of Science and the Cochrane Library and performed the meta-analysis of all randomized controlled trials (RCTs) and retrospective comparative studies assessing the prognostic factors of ART and SRT.
Between May 1998 and July 2012, 2 matched control studies and 16 retrospective studies including a total of 2629 cases were identified (1404 cases for ART and 1185 cases for SRT). 5-year biochemical failure free survival (BFFS) for ART was longer than that for SRT (Hazard Ratio [HR]: 0.37; 95% CI, 0.30–0.46; p<0.00001, I2 = 0%). 3-year BFFS was significantly longer in the ART (HR: 0.38; 95% CI, 0.28–0.52; p<0.00001, I2 = 0%). Overall survival (OS) was also better in the ART (RR: 0.53; 95% CI, 0.41–0.68; p<0.00001, I2 = 0%), as did disease free survival (DFS) (RR: 0.53; 95% CI, 0.43–0.66; p<0.00001, I2 = 0%). Exploratory subgroup analysis and sensitivity analysis revealed the similar results with original analysis.
ART therapy offers a safe and efficient alternative to SRT with longer 3-year and 5-year BFFS, better OS and DFS. Our recommendation is to suggest ART for patients with APFs and may reduce the need for SRT. Given the inherent limitations of the included studies, future well-designed RCTs are awaited to confirm and update this analysis.
PLoS ONE 08/2014; 9(8):e104918. DOI:10.1371/journal.pone.0104918 · 3.23 Impact Factor
"We developed a decision-analytic model to establish a framework to evaluate the potential costeffectiveness of ProsVue as an adjunctive prognostic marker to CAPRA-S risk stratification in comparison with the use of postoperative characteristics alone as characterized by the CAPRA-S risk group (i.e., standard care). The evaluation is limited to patients with intermediate-risk and high-risk CAPRA-S scores consistent with treatment guidelines . We report findings across a range of scenarios, including those in which the effect of the ProsVue slope is limited to decreasing the use of ART when the ProsVue slope value is 2 pg/mL/mo or less (i.e., the threshold in the US Food and Drug Administration [FDA] label indication to report that a patient is " at reduced risk " of clinical recurrence) and those in which ART increases when the ProsVue slope value is more than 2 pg/mL/mo. "
[Show abstract][Hide abstract] ABSTRACT: Objectives
The NADiA ProsVue is a prognostic system that measures prostate-specific antigen slope to identify men at lower risk of clinical recurrence of prostate cancer after radical prostatectomy. We developed a decision-modeling framework to evaluate its cost-effectiveness to guide the use of adjuvant radiotherapy (ART).
We populated the model using patient-level data and external sources. Patients were classified as intermediate risk or high risk on the basis of Cancer of the Prostate Risk Assessment-Postsurgical (CAPRA-S) nomogram and then stratified by the ProsVue slope (≤2 pg/mL/mo; >2 pg/mL/mo) and receipt of ART. In sensitivity analyses, we varied the effect of the ProsVue slope on the use of ART and other model parameters.
The cost-effectiveness of the ProsVue-guided strategy varied widely because of small differences in quality-adjusted life-years (QALYs) at 10 years. In the intermediate-risk group, when the use of ART decreased from 20% (standard care) to 7.5% among patients with a ProsVue slope value of 2 pg/mL/mo or less, the incremental cost-effectiveness ratio was $25,160/QALY. In the high-risk group, the use of ART would have to decrease from 40% (standard care) to 11.5% among those with a ProsVue slope value of 2 pg/mL/mo or less to obtain a ratio of $50,000/QALY. The cost-effectiveness ratios were sensitive to varying benefits of salvage therapy, quality of life, and costs of ART and ProsVue testing.
The effect of the ProsVue system on costs will be dependent on the extent to which ART decreases among men identified as having a low risk of recurrence. Its effect on QALYs will remain conditional on uncertain clinical and quality-of-life benefits associated with ART.
Value in Health 07/2014; 17(5). DOI:10.1016/j.jval.2014.04.010 · 3.28 Impact Factor
"However, approximately 20% of patients treated with RP have adverse pathologic features, defined as positive surgical margins (PSMs), extracapsular extension (ECE), seminal vesicle invasion (SVI), and/or lymph node invasion (LNI) [3,4]. Recently, in these patients with high-risk pathologic factors, the American Urological Association (AUA) and American Society for Radiation Oncology (ASTRO) have jointly recommended that adjuvant radiotherapy (ART) be offered . "
[Show abstract][Hide abstract] ABSTRACT: Recently, three prospective randomized trials have shown that adjuvant radiotherapy (ART) after radical prostatectomy for the patients with pT3 and/or positive margins improves biochemical progression-free survival and local recurrence free survival. But, the optimal management of these patients after radical prostatectomy is an issue which has been debated continuously. The object of this study was to determine the necessity of adjuvant radiotherapy (ART) by reviewing the outcomes of observation without ART after radical prostatectomy (RP) in patients with pathologic indications for ART according to the American Urological Association (AUA)/American Society for Radiation Oncology (ASTRO) guideline.
From a prospectively maintained database, 163 patients were eligible for inclusion in this study. These men had a pathological stage pT2-3 N0 with undetectable PSA level after RP and met one or more of the three following risk factors: capsular perforation, positive surgical margins, or seminal vesicle invasion. We excluded the patients who had received neoadjuvant hormonal therapy or adjuvant treatment, or had less than 24 months of follow-up. To determine the factors that influenced biochemical recurrence-free (BCR), univariate and multivariate Cox proportional hazards analyses were performed.
Among the 163 patients, median follow-up was 50.5 months (24.0-88.2 months). Of those men under observation, 27 patients had BCR and received salvage radiotherapy (SRT). The multivariate Cox analysis showed that BCR was marginally associated with pre-operative serum PSA (P = 0.082), and the pathologic GS (HR, 4.063; P = 0.001) was an independent predictor of BCR. More importantly, in 87 patients with pre-operative PSA < 6.35 ng/ml and GS <= 7, only 3 developed BCR.
Of the 163 patients who qualified for ART based on the current AUA/ASTRO guideline, only 27 (16.6%) developed BCR and received SRT. Therefore, using ART following RP using the current recommendation may be an overtreatment in an overwhelming majority of the patients.
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