Phase 2 Multicenter Trial of Heterogeneous-dosing Stereotactic Body Radiotherapy for Low- and Intermediate-risk Prostate Cancer: 5-year Outcomes

Fuller, Donald B.; Falchook, Aaron D.; Crabtree, Tami; Kane, Brent L.; Medbery, Clinton A.; Underhill, K.; Gray, James R.; Peddada, Anuj V.; Chen, Ronald C.

doi:10.1016/j.euo.2018.06.013

Cited by 51 publications

(28 citation statements)

References 28 publications

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“…This ablative PSA response approaches that typically observed following prostate brachytherapy, raising confidence in SBRT treatment efficacy [35]. At the time of most recent publication, PSA failure rates in these series were 2 and 4% at 36 months [31, 33], and 6–11% at 60–72 months [9, 34].…”

Section: Discussionmentioning

confidence: 77%

“…Follow-up for an additional 3–5 years revealed a continual PSA decline, with 84% of men attaining nadir under 0.5 ng/mL and a median PSA of 0.3 ng/mL at 5 years [9]. Fuller et al reported a median PSA nadir of 0.1 ng/mL at 42 months after SBRT of 38 Gy in four consecutive daily fractions [34]. This ablative PSA response approaches that typically observed following prostate brachytherapy, raising confidence in SBRT treatment efficacy [35].…”

Section: Discussionmentioning

confidence: 99%

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Stereotactic body radiotherapy with periprostatic hydrogel spacer for localized prostate cancer: toxicity profile and early oncologic outcomes

et al. 2019

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Background Multiple phase I-II clinical trials have reported on the efficacy and safety of prostate stereotactic body radiotherapy (SBRT) for the treatment of prostate cancer. However, few have reported outcomes for prostate SBRT using periprostatic hydrogel spacer (SpaceOAR; Augmenix). Herein, we report safety and efficacy outcomes from our institutional prostate SBRT experience with SpaceOAR placement. Methods Fifty men with low- or intermediate-risk prostate cancer treated at a single institution with linear accelerator-based SBRT to 3625 cGy in 5 fractions, with or without androgen deprivation therapy (ADT) were included. All patients underwent SpaceOAR and fiducial marker placement followed by pre-treatment MRI. Toxicity assessments were conducted at least weekly while on treatment, 1 month after treatment, and every follow-up visit thereafter. Post-treatment PSA measurements were obtained 4 months after SBRT, followed by every 3–6 months thereafter. Acute toxicity was documented per RTOG criteria. Results Median follow up time was 20 (range 4–44) months. Median PSA at time of diagnosis was 7.4 (2.7–19.5) ng/ml. Eighteen men received 6 months of ADT for unfavorable intermediate risk disease. No PSA failures were recorded. Median PSA was 0.9 ng/mL at 20 months; 0.08 and 1.32 ng/mL in men who did and did not receive ADT, respectively. Mean prostate-rectum separation achieved with SpaceOAR was 9.6 ± 4 mm at the prostate midgland. No grade ≥ 3 GU or GI toxicity was recorded. During treatment, 30% of men developed new grade 2 GU toxicity (urgency or dysuria). These symptoms were present in 30% of men at 1 month and in 12% of men at 1 year post-treatment. During treatment, GI toxicity was limited to grade 1 symptoms (16%), although 4% of men developed grade 2 symptoms during the first 4 weeks after SBRT. All GI symptoms were resolving by the 1 month post-treatment assessment and no acute or late rectal toxicity was reported > 1 month after treatment. Conclusions Periprostatic hydrogel placement followed by prostate SBRT resulted in minimal GI toxicity, and favorable early oncologic outcomes. These results indicate that SBRT with periprostatic spacer is a well-tolerated, safe, and convenient treatment option for localized prostate cancer. Electronic supplementary material The online version of this article (10.1186/s13014-019-1346-5) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 77%

Section: Discussionmentioning

confidence: 99%

Stereotactic body radiotherapy with periprostatic hydrogel spacer for localized prostate cancer: toxicity profile and early oncologic outcomes

et al. 2019

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“…Eligible patients were identified by querying 10 single-institution phase 2 trials and 2 multicenter prospective phase 2 trials ( NCT00643994 and NCT00643617 ; Table 1 ). 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 All patients received treatment between January 1, 2000, and December 31, 2012, for low-risk PCa or intermediate-risk PCa per the NCCN risk stratification scheme. 2 Intermediate-risk disease was further stratified into favorable and unfavorable intermediate-risk groups, with the latter category reserved for patients with primary Gleason pattern 4 disease, multiple intermediate-risk factors, or 50% or more positive cores.…”

Section: Methodsmentioning

confidence: 99%

Long-term Outcomes of Stereotactic Body Radiotherapy for Low-Risk and Intermediate-Risk Prostate Cancer

et al. 2019

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Importance Stereotactic body radiotherapy harnesses improvements in technology to allow the completion of a course of external beam radiotherapy treatment for prostate cancer in the span of 4 to 5 treatment sessions. Although mounting short-term data support this approach, long-term outcomes have been sparsely reported. Objective To assess long-term outcomes after stereotactic body radiotherapy for low-risk and intermediate-risk prostate cancer. Design, Setting, and Participants This cohort study analyzed individual patient data from 2142 men enrolled in 10 single-institution phase 2 trials and 2 multi-institutional phase 2 trials of stereotactic body radiotherapy for low-risk and intermediate-risk prostate cancer between January 1, 2000, and December 31, 2012. Statistical analysis was performed based on follow-up from January 1, 2013, to May 1, 2018. Main Outcomes and Measures The cumulative incidence of biochemical recurrence was estimated using a competing risk framework. Physician-scored genitourinary and gastrointestinal toxic event outcomes were defined per each individual study, generally by Radiation Therapy Oncology Group or Common Terminology Criteria for Adverse Events scoring systems. After central review, cumulative incidences of late grade 3 or higher toxic events were estimated using a Kaplan-Meier method. Results A total of 2142 men (mean [SD] age, 67.9 [9.5] years) were eligible for analysis, of whom 1185 (55.3%) had low-risk disease, 692 (32.3%) had favorable intermediate-risk disease, and 265 (12.4%) had unfavorable intermediate-risk disease. The median follow-up period was 6.9 years (interquartile range, 4.9-8.1 years). Seven-year cumulative rates of biochemical recurrence were 4.5% (95% CI, 3.2%-5.8%) for low-risk disease, 8.6% (95% CI, 6.2%-11.0%) for favorable intermediate-risk disease, 14.9% (95% CI, 9.5%-20.2%) for unfavorable intermediate-risk disease, and 10.2% (95% CI, 8.0%-12.5%) for all intermediate-risk disease. The crude incidence of acute grade 3 or higher genitourinary toxic events was 0.60% (n = 13) and of gastrointestinal toxic events was 0.09% (n = 2), and the 7-year cumulative incidence of late grade 3 or higher genitourinary toxic events was 2.4% (95% CI, 1.8%-3.2%) and of late grade 3 or higher gastrointestinal toxic events was 0.4% (95% CI, 0.2%-0.8%). Conclusions and Relevance In this study, stereotactic body radiotherapy for low-risk and intermediate-risk disease was associated with low rates of severe toxic events and high rates of biochemical control. These data suggest that stereotactic body radiotherapy is an appropriate definitive treatment modality for low-risk and intermediate-risk prostate cancer.

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“…In prostate cancer, an analogous situation with "SABRlike" brachytherapy exists wherein initially positive posttreatment biopsies do not correlate with local failure and ultimately convert to negative for malignancy at later time points [49,50,51]. Contemporary studies of SABR for prostate cancer also fit this paradigm, wherein maximal prostate-specific antigen (PSA) response can take 18-24 mo [52] and delayed post-treatment biopsy results (96% negative at 36 mo) best correlates with high biochemical control rates (98%) [53].…”

Section: Post-treatment Biopsymentioning

confidence: 99%

The Emerging Role of Stereotactic Ablative Radiotherapy for Primary Renal Cell Carcinoma: A Systematic Review and Meta-Analysis

Correa

Louie

Zaorsky

et al. 2019

European Urology Focus

107

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Context: Stereotactic ablative radiotherapy (SABR) is an emerging treatment option for primary renal cell carcinoma (RCC). Objective: To systematically review the literature on SABR for primary RCC and perform a meta-analysis evaluating local control (LC), toxicity, and renal function. Evidence acquisition: A PROSPERO-registered (#115573), Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA)-based systematic review of the literature was conducted (1995-2019). Studies of SABR targeting primary RCC tumors were included, while those targeting only metastases were excluded. The primary outcome was LC defined as tumor size reduction and/or absence of local progression. Secondary outcomes included toxicity (Common Terminology Criteria for Adverse Events) and renal function (change in estimated glomerular filtration rate [eGFR]). Weighted random-effect meta-analyses using the DerSimonian and Laird method were conducted for primary and secondary outcomes. The I 2 statistic and Cochran's Q test were used to assess heterogeneity. Evidence synthesis: From 2386 PubMed entries and 924 meeting abstracts, 26 studies were identified (11 prospective trials), including 383 tumors in 372 patients, most of whom were deemed inoperable. Weighted averages (ranges) of median follow-up, median age, and mean tumor size were 28.0 (5.8-79.2) mo, 70.4 (62-83) yr, and 4.6 (2.3-9.5) cm, respectively. RCC histology was confirmed in 78.9% of patients who

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Phase 2 Multicenter Trial of Heterogeneous-dosing Stereotactic Body Radiotherapy for Low- and Intermediate-risk Prostate Cancer: 5-year Outcomes

Cited by 51 publications

References 28 publications

Stereotactic body radiotherapy with periprostatic hydrogel spacer for localized prostate cancer: toxicity profile and early oncologic outcomes

Stereotactic body radiotherapy with periprostatic hydrogel spacer for localized prostate cancer: toxicity profile and early oncologic outcomes

Long-term Outcomes of Stereotactic Body Radiotherapy for Low-Risk and Intermediate-Risk Prostate Cancer

The Emerging Role of Stereotactic Ablative Radiotherapy for Primary Renal Cell Carcinoma: A Systematic Review and Meta-Analysis

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