Long-term efficacy of stereotactic body radiotherapy for localized prostate cancer: A multi-institutional pooled analysis.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 9-9 ◽  
Author(s):  
Patrick Kupelian ◽  
Alan J. Katz ◽  
Debra Freeman ◽  
Irving D. Kaplan ◽  
Donald B. Fuller ◽  
...  

9 Background: The purpose of this study is to report biochemical relapse-free survival (bRFS) rates for a group of localized prostate cancer patients from a pooled multi-institutional dataset with at least 5 years follow-up after stereotactic body radiotherapy (SBRT). Methods: The outcome data from 1101 patients treated with SBRT between 2003 and 2011 were pooled from 8 institutions. A subset of 135 cases had a minimum 5 years follow-up. All 135 cases had clinical stage T1 or T2A disease. The distribution by Gleason score (GS) was <6 in 80% and 7 in 20%. The median pretreatment PSA (iPSA) level was 5.1 ng/ml (range: 0.1-27.8). The distribution by risk was 77% low, 21% intermediate, and 2% high risk. The median dose was 36.25 Gy (35-40 Gy range) delivered either with 4 or 5 fractions. The prescribed dose groups were as follows: 35 Gy in 42%, 36.25 Gy in 47%, and >38 Gy in 11%. Androgen deprivation therapy was given to 21% of patients. Biochemical relapse, defined as a rise > 2 ng/ml above nadir, was determined in a total of 4 failures. Results: The median follow-up for all 135 cases was 60 months (range 60 to 72). For all patients, the bRFS rate at 5 years was 97%. The 5-year actuarial bRFS rates for GS < 6, and Gleason score 7 were 98%, and 92%, respectively (p=0.15). The 5-year actuarial bRFS rates for low versus intermediate/high-risk patients were 99% and 93%, respectively (p=0.11). The 5-year actuarial bRFS rates for patients receiving 35 Gy versus >36.25 Gy were 93% and 100%. No difference in bRFS was observed with the use of androgen deprivation (p=0.78). Multivariate analysis showed only GS to be an independent predictor of relapse (p=0.03); iPSA (p=0.10) and radiation dose (0.97) were not. Conclusions: In a relatively large cohort of localized prostate cancer patients treated with SBRT, long follow-up period (>5 years), excellent efficacy was demonstrated with 97% of patients being free from relapse. For low and intermediate risk cases, these results compare favorably with other modalities with similar follow-up periods. Although a trend for worse outcome was seen with total radiation doses of 35 Gy, this was not confirmed on multivariate analysis.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 46-46 ◽  
Author(s):  
Amar Upadhyaya Kishan ◽  
Donald B. Fuller ◽  
Michael L. Steinberg ◽  
Victoria Ramirez ◽  
Nzhde Agazaryan ◽  
...  

46 Background: Stereotactic body radiotherapy (SBRT) for high-risk prostate cancer (CaP) remains investigational not only due to undetermined efficacy but also due to concerns for the potential toxicity when the treatment volumes extend beyond the prostate gland itself. Methods: Men with high-risk CaP, as defined by Gleason score > = 8, clinical stage T3-T4, or initial PSA > = 20 ng/mL, were enrolled on a multicenter phase II trial and were treated with 40 Gy to prostate and 25 Gy to pelvic nodes in 5 fractions and 9 months neoadjuvant and concurrent ADT. Treatment with ADT and pelvic nodal radiation was at the discretion of the treating physician. Follow-up assessment was with CTCAE v4 and Expanded Prostate Composite Index (EPIC). Results: A total of 61 patients were treated, with a median follow-up of 12 months. Forty (64.4%) received ADT and 23 (37.1%) received nodal radiation. The median initial PSA was 8.1 ng/mL and 8% of patients had clinical T3-T4 disease; 45.9% and 39.3% had Gleason score 8 and 9-10 disease, respectively. No grade 3 or higher toxicities were seen. Rates of acute and late grade 2 genitourinary toxicities were 13.1% and 6.7%, respectively; rates of acute and late grade 2 gastrointestinal toxicities were 6.6% and 8.2%, respectively. Mean changes in EPIC urinary incontinence, urinary obstructive, and bowel domain scores at 4 months were -0.35, +1.44, and -2.38, respectively. For the 32 patients with evaluable EPIC scores at 12 months, mean changes on EPIC urinary incontinence, urinary obstructive, and bowel domain scores at 4 months were -1.04, -2.70, and -6.76, respectively. The percentages of patients with minimum clinically important change in EPIC urinary incontinence, urinary obstructive, and bowel domain scores at 4 months were 11.9%, 21.4%, and 26.2%, respectively. At 12 months, these figures were 13.9%, 30.6% and 27.8%. The receipt of ADT and/or nodal radiation had no significant effect on either physician- or patient-reported toxicity profiles (p > 0.1, Fisher’s exact test). Conclusions: SBRT regimens can be safely utilized to deliver the entire course in 5 treatment days in patients with high-risk localized CaP. Clinical trial information: NCT02296229.


2019 ◽  
pp. 1-9 ◽  
Author(s):  
Simpa S. Salami ◽  
Udit Singhal ◽  
Daniel E. Spratt ◽  
Ganesh S. Palapattu ◽  
Brent K. Hollenbeck ◽  
...  

PURPOSE Using nonenrichment-based, potentially more sensitive Epic Sciences circulating tumor cell (CTC) platform, we sought to detect and characterize CTCs in untreated, high-risk localized prostate cancer and to evaluate their clinical implication. METHODS Between 2012 and 2015, blood samples were prospectively collected from patients with National Comprehensive Cancer Network high-risk localized prostate cancer undergoing either radiotherapy (XRT) plus androgen deprivation therapy or radical prostatectomy (RP) with curative intent. Samples were analyzed with the Epic Sciences platform with 4′,6-diamidino-2-phenylindole, CD45, cytokeratin (CK), and androgen receptor (AR) N-terminal staining. CTC counts were correlated with biochemical recurrence (BCR). RESULTS A diversity of CTC subtypes, including CK-positive, CK-negative, AR-positive, and CTC clusters, were observed in 73.3% (33 of 45) of patients with evaluable data. The median follow-up was 14.2 months (range, 0.5 to 43.7 months). BCR occurred more frequently in the RP group than XRT (15 of 26 v one of 19), with most patients in the XRT group continuing to receive androgen deprivation therapy. A higher proportion of metastatic events were observed in the RP group (five of 26 v one of 19). In the RP group, BCR and development of metastases were associated with a higher total number of CTCs, AR-positive CTCs, and CTC phenotypic heterogeneity. One patient who developed BCR and metastases quickly after RP had diverse phenotypical CTC subtypes, and single-cell genomic analyses of all detectable CTCs confirmed common prostate cancer copy number alterations and PTEN loss. CONCLUSION CTCs can be identified in most patients with high-risk localized prostate cancer before definitive therapy using the Epic Sciences platform. If confirmed in a larger cohort with longer follow-up, phenotypic and genomic characterization of CTCs pretherapy may provide an additional means of risk stratifying patients with newly diagnosed high-risk disease and potentially help identify patients who could require multimodal therapy.


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