Phase II study of accelerated Linac-based SBRT in five consecutive fractions for localized prostate cancer

Alongi, Filippo; Mazzola, Rosario; Fiorentino, Alba; Corradini, Stefanie; Aiello, D.; Figlia, Vanessa; Gregucci, Fabiana; Ballario, R; Cavalleri, Stefano; Ruggieri, R.

doi:10.1007/s00066-018-1338-7

Cited by 37 publications

(31 citation statements)

References 31 publications

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“…Of note, a clear relationship between the delivered dose and the occurrence of late grade ≥ 3 GU toxicity has been demonstrated in a meta‐regression analysis of 5127 patients treated with prostate SBRT . This was confirmed by the low GU toxicity rates, comparable to our study, observed in 18 patients treated in a phase II SBRT trial delivering 37.5 Gy in 5 consecutive fractions to the prostate and between 33.2 and 35 Gy to the urethra …”

Section: Discussionsupporting

confidence: 87%

Once‐a‐week or every‐other‐day urethra‐sparing prostate cancer stereotactic body radiotherapy, a randomized phase II trial: 18 months follow‐up results

Zilli

Jorcano²,

Bral

et al. 2020

Cancer Medicine

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Background:To present the 18 months results from a prospective multicenter phase II randomized trial of short vs protracted urethra-sparing stereotactic body radiotherapy (SBRT) for localized prostate cancer (PCa). Methods: Between 2012 and 2015, a total of 170 PCa patients were randomized to 36.25 Gy in 5 fractions (6.5 Gy × 5 to the urethra) delivered either every other day (EOD, arm A, n = 84) or once a week (QW, arm B, n = 86). Genitourinary (GU) and gastrointestinal (GI) toxicity (CTCAE v4.0 scale), IPSS, and QoL scores were assessed at baseline, at the 5th fraction (5fx), 12th weeks (12W), and every 6 months after SBRT. The primary endpoint was biochemical control at 18 months and grade ≥ 3 toxicity (including grade ≥ 2 for urinary obstruction/retention) during the first 3 months. Results: Among the 165 patients analyzed, the toxicity stopping rule was never activated during the acute phase. Maximum acute grade 2 GU toxicity rates at 5fx were 17% and 19% for arms A and B, respectively, with only 2 cases of grade 2 GI toxicity at 5fx in arm A. At month 18, grade ≥ 2 GU and GI toxicity decreased below 5% and 2% for both arms. No changes in EORTC QLQ-PR25 scores for GU, GI, and sexual domains were observed in both arms between baseline and month 18. Four biochemical failures were observed, 2 in each arm, rejecting the null hypothesis of an unfavorable response rate ≤ 85% in favor of an acceptable ≥ 95% rate. Conclusions: At 18 months, urethra-sparing SBRT showed a low toxicity profile, with minimal impact on QoL and favorable biochemical control rates, regardless of overall treatment time (EOD vs QW). K E Y W O R D Soverall treatment time, prostate cancer, quality of life, stereotactic body radiotherapy, urethra sparing 3098 | ZILLI et aL.

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Section: Discussionsupporting

confidence: 87%

Once‐a‐week or every‐other‐day urethra‐sparing prostate cancer stereotactic body radiotherapy, a randomized phase II trial: 18 months follow‐up results

Zilli

Jorcano²,

Bral

et al. 2020

Cancer Medicine

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“…In the case of low-risk PC, the clinical target volume (CTV) was the prostate gland only, whereas in the case of intermediate-risk PC, the entirety of the seminal vesicles (SV) was included. The planning target volume (PTV) consisted of CTV + 5 mm margins in each direction, except 3 mm posteriorly, according to previously published experiences [12]. As organs at risk, the rectum, bladder, penile bulb, urethra, and femoral heads were delineated.…”

Section: T Mr-guided Radiotherapymentioning

confidence: 99%

“…Moreover, since 2014, the National Comprehensive Cancer Network (NCCN) Guidelines [9] have stated that, in centers with appropriate technology and expertise, extreme hypofractionated treatment could be considered as a potential option to offer for selected localized PC. Since then, more robust evidence and new technological platforms are consolidating the role of extreme hypofractionation (also known as stereotactic body radiotherapy -SBRT) for localized PC [10][11][12].…”

Section: Introductionmentioning

confidence: 99%

1.5 T MR-guided and daily adapted SBRT for prostate cancer: feasibility, preliminary clinical tolerability, quality of life and patient-reported outcomes during treatment

et al. 2020

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Background: Unity Elekta is a unique magnetic resonance (MR)-linac that conjugates a 1.5 Tesla MR unit with a 7 MV flattening filter free accelerator.A prospective observational study for the clinical use of Elekta Unity is currently ongoing in our department. Herein, we present our preliminary report on the feasibility, quality of life, and patientreported outcomes measures (PROMs) for localized prostate cancer (PC) treated with stereotactic body radiotherapy (SBRT). Methods: The SBRT protocol consisted of a 35 Gy schedule delivered in 5 fractions within 2 weeks. Toxicity and quality of life (QoL) were assessed at baseline and after treatment using the Common Terminology Criteria for Adverse Events v5.0, International Prostatic Symptoms Score (IPSS), ICIQ-SF, IIEF-5, and EORTC-QLQ-C30 and PR-25 questionnaires. Results: Between October 2019 and January 2020, 25 patients with localized PC were recruited. The median age was 68 years (range, 54-82); 4 were low risk, 11 favorable intermediate risk (IR) and 10 unfavorable IR. Median iPSA was 6.8 ng/ml (range, 1-19), and 9 of these patients (36%) received concurrent androgen deprivation therapy. Median prostate volume was 36 cc (range, 20-61); median baseline IPSS was 5 (range, 0-10). Median time for fraction was 53 min (range, 34-86); adaptive strategy with daily critical structure and target re-contouring and daily replanning (adapt to shape) was performed in all cases. No grade ≥ 3 adverse event was observed, three patients (12%) reported grade 2 acute genitourinary toxicity (urinary frequency, urinary tract pain and urinary retention), while only one patient reported mild rectal pain. No relevant deteriorations were reported in PROMs.

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“…In the case of low-risk PC, the clinical target volume (CTV) was the prostate gland only, whereas in the case of intermediaterisk PC, the entirety of the seminal vesicles (SV) was included. The planning target volume (PTV) consisted of CTV +5mm margins in each direction, except 3mm posteriorly, according to previously published experiences [12]. As organs at risk, the rectum, bladder, penile bulb, urethra, and femoral heads were delineated.…”

Section: 5t Mr-guided Radiotherapymentioning

confidence: 99%

“…Guidelines [9] have stated that, in centers with appropriate technology and expertise, extreme hypofractionated treatment could be considered as a potential option to offer for selected localized PC. Since then, more robust evidence and new technological platforms are consolidating the role of extreme hypofractionation (also known as stereotactic body radiotherapy -SBRT) for localized PC [10][11][12].…”

Section: Introductionmentioning

confidence: 99%

1.5T MR-guided and daily adapted SBRT for prostate cancer: feasibility, preliminary clinical tolerability, quality of life and patient-reported outcomes during treatment

Alongi

Rigo

Figlia

et al. 2020

Preprint

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Background Unity Elekta is a unique magnetic resonance (MR)-linac that conjugates a 1.5 Tesla MR unit with a 7 MV flattening filter free accelerator.A prospective observational study for the clinical use of Elekta Unity is currently ongoing in our department. Herein, we present our preliminary report on the feasibility, quality of life, and patient-reported outcomes measures (PROMs) for localized prostate cancer (PC) treated with stereotactic body radiotherapy (SBRT). Methods The SBRT protocol consisted of a 35 Gy schedule delivered in 5 fractions within two weeks. Toxicity and quality of life (QoL) were assessed at baseline and after treatment using the Common Terminology Criteria for Adverse Events v5.0, International Prostatic Symptoms Score (IPSS), ICIQ-SF, IIEF-5, and EORTC-QLQ-C30 and PR-25 questionnaires. Results Between October 2019 and January 2020, 25 patients with localized PC were recruited. The median age was 68 years (range, 54-82); 4 were low risk, 11 favorable intermediate risk (IR) and 10 unfavorable IR. Median iPSA was 6.8 ng/ml (range, 1-19), and 9 of these patients (36%) received concurrent androgen deprivation therapy. Median prostate volume was 36 cc (range, 20-61); median baseline IPSS was 5 (range, 0-10). Median time for fraction was 53 minutes (range, 34-86); adaptive strategy with daily critical structure and target re-contouring and daily replanning (adapt to shape) was performed in all cases. No grade ≥ 3 adverse event was observed, three patients (12%) reported grade 2 acute genitourinary toxicity (urinary frequency, urinary tract pain and urinary retention), while only one patient reported mild rectal pain. No relevant deteriorations were reported in PROMs. Conclusion To the best of our knowledge, this is the first experience reporting feasibility, clinician-reported outcome measurements, and PROMs for 1.5T MR-guided adaptive SBRT for localized prostate cancer. The preliminary data collected here report optimal safety and excellent tolerability, as also confirmed by PROMs questionnaires. Moreover, the data on technical feasibility and timing of online daily adapted planning and delivery are promising. More mature data are warranted.

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Phase II study of accelerated Linac-based SBRT in five consecutive fractions for localized prostate cancer

Cited by 37 publications

References 31 publications

Once‐a‐week or every‐other‐day urethra‐sparing prostate cancer stereotactic body radiotherapy, a randomized phase II trial: 18 months follow‐up results

Once‐a‐week or every‐other‐day urethra‐sparing prostate cancer stereotactic body radiotherapy, a randomized phase II trial: 18 months follow‐up results

1.5 T MR-guided and daily adapted SBRT for prostate cancer: feasibility, preliminary clinical tolerability, quality of life and patient-reported outcomes during treatment

1.5T MR-guided and daily adapted SBRT for prostate cancer: feasibility, preliminary clinical tolerability, quality of life and patient-reported outcomes during treatment

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