Hyprofractionated Versus Conventionally Fractionated Radiation Therapy for Patients with Intermediate- or High-Risk, Localized, Prostate Cancer: 7-Year Outcomes From the Randomized, Multicenter, Open-Label, Phase 3 HYPRO Trial

Vries, Kim C. de; Wortel, Ruud C.; Hoop, Esther Oomen–de; Heemsbergen, Wilma D.; Pos, Floris J.; Incrocci, Luca

doi:10.1016/j.ijrobp.2019.09.007

Cited by 44 publications

(33 citation statements)

References 29 publications

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“…As previously described for this data set [16] , high-risk patients (Gleason 8) in the HF arm experienced significantly fewer local recurrences than in the CF arm, even though there was no difference in overall failure free survival. This suggests that for a high-risk subgroup the HF scheme may be more effective to treat the primary tumor (receiving full dose prescription), but at the same time perhaps less effective at eradicating subclinical disease receiving intermediate levels of incidental dose.…”

Section: Discussionsupporting

confidence: 66%

“…For our analysis we considered patients with sufficient follow-up from the updated database [16] and available treatment planning CT and 3D dose distribution, at intermediate (CF: 90 patients, HF: 86 patients) and high prognostic risk (CF: 249 patients, HF: 241 patients), analyzing in total 666 out of the 804 patients (83%) of the total HYPRO study population previously available for relapse-free survival analysis. Relapse was defined as biochemical relapse, clinical relapse, locoregional or distant relapse, or start with hormonal therapy, whichever happened first.…”

Section: Methodsmentioning

confidence: 99%

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Association between incidental dose outside the prostate and tumor control after modern image-guided radiotherapy

Witte

Pos

Incrocci

et al. 2021

Physics and Imaging in Radiation Oncology

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Background and purpose External beam radiotherapy for prostate cancer deposits incidental dose to a region surrounding the target volume. Previously, an association was identified between tumor control and incidental dose for patients treated with conventional radiotherapy. We investigated whether such an association exists for patients treated using intensity modulated radiotherapy (IMRT) and tighter margins. Materials and methods Computed tomography scans and three-dimensional treatment planning dose distributions were available from the Dutch randomized HYPRO trial for 397 patients in the standard fractionation arm (39 × 2 Gy) and 407 patients in the hypofractionation arm (19 × 3.4 Gy), mainly delivered using online image-guided IMRT. Endpoint was any treatment failure within 5 years. A mapping of 3D dose distributions between anatomies was performed based on distance to the surface of the prostate delineation. Mean mapped dose distributions were computed for patient groups with and without failure, obtaining dose difference distributions. Random patient permutations were performed to derive p values and to identify relevant regions. Results For high-risk patients treated in the conventional arm, higher incidental dose was significantly associated with a higher probability of tumor control in both univariate and multivariate analysis. The locations of the excess dose mainly overlapped with the position of obturator internus muscles at about 2.5 cm from the prostate surface. No such relationship could be established for intermediate-risk patients. Conclusions An association was established between reduced treatment failure and the delivery of incidental dose outside the prostate for high-risk patients treated using conventionally fractionated IMRT.

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Section: Discussionsupporting

confidence: 66%

Section: Methodsmentioning

confidence: 99%

Association between incidental dose outside the prostate and tumor control after modern image-guided radiotherapy

Witte

Pos

Incrocci

et al. 2021

Physics and Imaging in Radiation Oncology

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“…These RT-technological and technical advances have allowed clinicians to deliver higher radiation doses to the target with similarly limited toxicities. To date, moderate PC hypofractionation represents the standard of care [7,8]. 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.…”

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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“…This means that irradiating with doses per fraction greater than conventional fractionation (CF) would deliver a greater biologically equivalent dose (BED) to the prostate, without significantly increasing late normal tissue toxicity. The outcomes of studies employing doseescalated CF (78-81 Gy) [1] are comparable with those of moderate hypofractionation (MH; 2.4-4 Gy per fraction) [2][3]. In recent years, multiple phase two and phase three studies employing extreme hypofractionation (EH; ≥5 Gy per fraction) have also reported excellent control rates with acceptable bladder and rectal toxicity.…”

Section: Introductionmentioning

confidence: 94%

Phase I/II Study of Extreme Hypofractionated Stereotactic Body Radiation Therapy Boost to Prostate for Locally Advanced, Node-Positive and Oligometastatic Cancer

Narang¹,

Kadian²,

Venkatesan³

et al. 2020

Cureus

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Introduction: Stereotactic body radiation therapy (SBRT) is increasingly being utilized to deliver escalated radiation doses for improving outcomes in various malignancies. We analyzed our cohort of locally advanced, node-positive, and bone oligometastatic prostate cancer patients, that were treated with a combination of pelvic RT using conventional fractionation (CF) and SBRT boost to prostate using extreme hypofractionation (EH), along with hormone therapy (HT). Materials and Methods: Outcomes of 44 prospectively treated patients were analyzed. Volumetric modulated arc therapy (VMAT) was utilized to deliver a dose of 45 Gy to pelvic nodal region, 50 Gy to prostate, and 54-56 Gy to gross nodes in 25 fractions. EH boost 18 Gy in three fractions was delivered to the prostate using CyberKnife (Accuray, Sunnyvale, CA, USA) SBRT. Bone oligometastasis, if any, were treated to a dose of 16 Gy in two fractions, delivered on weekends. Serum prostate-specific antigen (PSA), multi-parametric magnetic resonance imaging (MRI) of pelvis, and prostate-specific membrane antigen-positron emission tomography (PSMA-PET) were used for response assessment during follow-up. HT was given as per standard guidelines. Results: There were 33 (75%) locally advanced, nine (20.5%) node-positive, and two (4.5%) oligometastatic cases. At a median follow-up of 63.5 months, the five-year progression-free survival (PFS) was 88.2%, biochemical PFS (bPFS) was 91.4% and overall survival (OS) was 96.9%. Grade III or greater acute genitourinary and gastrointestinal toxicity was 2.3% each, and late toxicity was 4.5% and 0%, respectively. Conclusion: Excellent five-year outcomes can be attained even for locally advanced, node-positive and bone oligometastatic prostate cancer, by means of dose-escalation using EH-SBRT boost to the prostate.

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Hyprofractionated Versus Conventionally Fractionated Radiation Therapy for Patients with Intermediate- or High-Risk, Localized, Prostate Cancer: 7-Year Outcomes From the Randomized, Multicenter, Open-Label, Phase 3 HYPRO Trial

Cited by 44 publications

References 29 publications

Association between incidental dose outside the prostate and tumor control after modern image-guided radiotherapy

Association between incidental dose outside the prostate and tumor control after modern image-guided radiotherapy

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

Phase I/II Study of Extreme Hypofractionated Stereotactic Body Radiation Therapy Boost to Prostate for Locally Advanced, Node-Positive and Oligometastatic Cancer

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