Top

Strahlentherapie und Onkologie

Published in:

01-11-2021 | Prostate Cancer | Original Article

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial

Authors: Paul Nguyen, Ludovic Harzée, Paul Retif, Stéphane Joseph, Guillaume Vogin, Philippe Nickers

Published in: Strahlentherapie und Onkologie | Issue 11/2021

Abstract

Purpose

There are no safety-focused trials on stereotactic body radiotherapy (SBRT) for localized prostate cancer. This prospective 3‑year phase II trial used binomial law to validate the safety and efficacy of SBRT with stringent organ at risk dose constraints that nevertheless permitted high planning target volume doses.

Methods

All consecutive ≥ 70-year-old patients with localized prostate adenocarcinoma who underwent SBRT between 2014 and 2018 at the National Radiotherapy Center in Luxembourg were included. Patients with low Cancer of Prostate Risk Assessment (CAPRA) scores (0–2) and intermediate scores (3–5) received 36.25 Gy. High-risk (6–10) patients received 37.5 Gy. Radiation was delivered in 5 fractions over 9 days with Cyberknife-M6™ (Accuray, Sunnyvale, CA, USA). Primary study outcome was Common Terminology Criteria for Adverse Events version 4 (CTCAEv4) genitourinary and rectal toxicity scores at last follow-up. Based on binomial law, SRBT was considered safe in this cohort of 110 patients if there were ≤ 2 severe toxicity (CTCAEv4 grade ≥ 3) cases. Secondary outcomes were biochemical progression-free survival (bPFS) and patient quality of life (QOL), as determined by the IPPS and the Urinary Incontinence QOL questionnaire.

Results

The first 110 patients who were accrued in a total cohort of 150 patients were included in this study and had a median follow-up of 36 months. Acute grade ≥ 3 toxicity never occurred. One transient late grade 3 case was observed. Thus, our SBRT program had an estimated severe toxicity rate of < 5% and was safe at the p < 0.05 level. Overall bPFS was 90%. QOL did not change relative to baseline.

Conclusion

The trial validated our SBRT regimen since it was both safe and effective.

Dearnaley D, Syndikus I, Mossop H et al (2016) Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer : 5‑year outcomes of the randomised , non-inferiority , phase 3 CHHiP trial. Lancet Oncol 17(8):1047–1060. https://doi.org/10.1016/S1470-2045(16)30102-4CrossRefPubMedPubMedCentral

Catton CN, Lukka H, Gu CS et al (2017) Randomized trial of a hypofractionated radiation regimen for the treatment of localized prostate cancer. J Clin Oncol 35(17):1884–1890. https://doi.org/10.1200/JCO.2016.71.7397CrossRefPubMed

Incrocci L, Wortel RC, Alemayehu WG et al (2016) Hypofractionated versus conventionally frationated radiotherapy for patients with localised prostate cancer ( HYPRO ): final efficacy results from a randomised , multicentre , open-label , phase 3 trial. Lancet Oncol 2045(16):1–9. https://doi.org/10.1016/S1470-2045(16)30070-5CrossRef

Demanes DJ, Martinez AA, Ghilezan M et al (2011) High-dose-rate monotherapy: safe and effective brachytherapy for patients with localized prostate cancer. Int J Radiat Oncol Biol Phys 81(5):1286–1292. https://doi.org/10.1016/j.ijrobp.2010.10.015CrossRefPubMed

Barkati M, Williams SG, Foroudi F et al (2012) High-dose-rate brachytherapy as a monotherapy for favorable-risk prostate cancer: a phase II trial. Int J Radiat Oncol Biol Phys 82(5):1889–1896. https://doi.org/10.1016/j.ijrobp.2010.09.006CrossRefPubMed

Morgan SC, Hoffman K, Loblaw DA et al (2018) Hypofractionated radiation therapy for localized prostate cancer: an ASTRO, ASCO, and AUA evidence-based guideline. J Clin Oncol 36(34):3411–3430. https://doi.org/10.1200/JCO.18.01097CrossRefPubMedCentral

King CR, Freeman D, Kaplan I et al (2013) Stereotactic body radiotherapy for localized prostate cancer : pooled analysis from a multi-institutional consortium of prospective phase II trials. Radiother Oncol 109(2):217–221. https://doi.org/10.1016/j.radonc.2013.08.030CrossRefPubMed

Meier RM, Bloch DA, Cotrutz C et al (2018) Multicenter trial of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer : survival and toxicity endpoints. Int J Radiat Oncol Biol Phys 102(2):296–303. https://doi.org/10.1016/j.ijrobp.2018.05.040CrossRefPubMed

Alayed Y, Cheung P, Pang G et al (2018) Dose escalation for prostate stereotactic ablative radiotherapy (SABR): late outcomes from two prospective clinical trials. Radiother Oncol 127(2):213–218. https://doi.org/10.1016/j.radonc.2018.03.005CrossRefPubMed

10.

Kishan AU, Dang A, Katz AJ et al (2019) Long-term outcomes of Stereotactic body radiotherapy for low-risk and intermediate-risk prostate cancer. JAMA Netw Open 2(2):1–13. https://doi.org/10.1001/jamanetworkopen.2018.8006CrossRef

11.

Katz A, Kang J (2014) Stereotactic body radiotherapy as treatment for organ confined low and intermediate risk prostate carcinoma, a seven year study. Front Oncol. https://doi.org/10.3389/fonc.2014.00240CrossRefPubMedPubMedCentral

12.

Jackson WC, Silva J, Hartman HE et al (2019) Stereotactic body radiation therapy for localized prostate cancer: a systematic review and meta-analysis of over 6,000 patients treated on prospective studies. Int J Radiat Oncol Biol Phys 104(4):778–789. https://doi.org/10.1016/j.ijrobp.2019.03.051CrossRefPubMedPubMedCentral

13.

Widmark A, Gunnlaugsson A, Beckman L et al (2019) Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5‑year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. Lancet 394(10196):385–395. https://doi.org/10.1016/S0140-6736(19)31131-6CrossRefPubMed

14.

Brand DH, Tree AC, Ostler P et al (2019) Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial. Lancet Oncol 20(11):1531–1543. https://doi.org/10.1016/S1470-2045(19)30569-8CrossRefPubMedPubMedCentral

15.

Viani GA, Stefano EJ, Afonso SL (2009) Higher-than-conventional radiation doses in localized prostate cancer treatment: a meta-analysis of randomized, controlled trials. Int J Radiat Oncol Biol Phys 74(5):1405–1418. https://doi.org/10.1016/j.ijrobp.2008.10.091CrossRefPubMed

16.

Heemsbergen WD, Al-Mamgani A, Slot A, Dielwart MFH, Lebesque JV (2014) Long-term results of the Dutch randomized prostate cancer trial: Impact of dose-escalation on local, biochemical, clinical failure, and survival. Radiother Oncol 110(1):104–109. https://doi.org/10.1016/j.radonc.2013.09.026CrossRefPubMed

17.

Peeters STH, Heemsbergen WD, Van Putten WLJ et al (2005) Acute and late complications after radiotherapy for prostate cancer: Results of a multicenter randomized trial comparing 68 Gy to 78 Gy. Int J Radiat Oncol Biol Phys 61(4):1019–1034. https://doi.org/10.1016/j.ijrobp.2004.07.715CrossRefPubMed

18.

Parker CC, James ND, Brawley CD et al (2018) Articles Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial. Lancet 392(10162):2353–2366. https://doi.org/10.1016/S0140-6736(18)32486-3CrossRefPubMedPubMedCentral

19.

Dearnaley DP, Sydes MR, Langley RE et al (2007) The early toxicity of escalated versus standard dose conformal radiotherapy with neo-adjuvant androgen suppression for patients with localised prostate cancer: Results from the MRC RT01 trial (ISRCTN47772397). Radiother Oncol 83(1):31–41. https://doi.org/10.1016/j.radonc.2007.02.014CrossRefPubMed

20.

Matzinger O, Duclos F, van den Bergh A et al (2009) Acute toxicity of curative radiotherapy for intermediate- and high-risk localised prostate cancer in the EORTC trial 22991. Eur J Cancer 45(16):2825–2834. https://doi.org/10.1016/j.ejca .2009.07.009CrossRef

21.

Zelefsky MJ, Chan H, Hunt M, Yamada Y, Shippy AM, Amols H (2006) Long-term outcome of high dose intensity modulated radiation therapy for patients with clinically localized prostate cancer. J Urol 176(4):1415–1419. https://doi.org/10.1016/j.juro.2006.06.002CrossRefPubMed

22.

Cooperberg MR, Pasta DJ, Elkin EP et al (2005) The university of California, san Francisco cancer of the prostate risk assessment score: a straightforward and reliable preoperative predictor of disease recurrence after radical prostatectomy. J Urol 173(6):1938–1942. https://doi.org/10.1097/01.ju.0000158155.33890.e7CrossRefPubMedPubMedCentral

23.

Wilke L, Andratschke N, Blanck O et al (2019) ICRU report 91 on prescribing, recording, and reporting of stereotactic treatments with small photon beams: Statement from the DEGRO/DGMP working group stereotactic radiotherapy and radiosurgery. Strahlenther Onkol 195(3):193–198. https://doi.org/10.1007/s00066-018-1416-xCrossRefPubMed

24.

Roach M, Hanks G, Thames H et al (2006) Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference. Int J Radiat Oncol Biol Phys 65(4):965–974. https://doi.org/10.1016/j.ijrobp.2006.04.029CrossRefPubMed

25.

Loi M, Wortel RC, Francolini G, Incrocci L (2019) Sexual function in patients treated with stereotactic radiotherapy for prostate cancer : a systematic review of the current evidence selection criteria and search strategy validity of included studies. J Sex Med 16(9):1409–1420. https://doi.org/10.1016/j.jsxm.2019.05.019CrossRefPubMed

26.

Royce TJ, Mavroidis P, Wang K et al (2021) Tumor control probability modeling and systematic review of the literature of stereotactic body radiation therapy for prostate cancer. Int J Radiat Oncol Biol Phys 110(1):227–236. https://doi.org/10.1016/j.ijrobp.2020.08.014CrossRefPubMed

27.

Wang K, Mavroidis P, Royce TJ et al (2021) Prostate stereotactic body radiation therapy: an overview of toxicity and dose response. Int J Radiat Oncol Biol Phys 110(1):237–248. https://doi.org/10.1016/j.ijrobp.2020.09.054CrossRefPubMed

28.

Mahase SS, D’Angelo D, Kang J, Hu JC, Barbieri CE, Nagar H (2020) Trends in the use of stereotactic body radiotherapy for treatment of prostate cancer in the United States. JAMA Netw Open 3(2):1–12. https://doi.org/10.1001/jamanetworkopen.2019.20471CrossRef

29.

Bolzicco G, Favretto MS, Satariano N, Scremin E, Tambone C, Tasca A (2013) A single-center study of 100 consecutive patients with localized prostate cancer treated with stereotactic body radiotherapy. BMC Urol 13(1):1. https://doi.org/10.1186/1471-2490-13-49CrossRef

30.

Tree AC, Ostler P, Hoskin P et al (2014) Prostate stereotactic body radiotherapy—first UK experience. Clin Oncol 26(12):757–761. https://doi.org/10.1016/j.clon.2014.08.007CrossRef

31.

Koskela K, Palmgren JE, Heikkilä J et al (2017) Hypofractionated stereotactic body radiotherapy for localized prostate cancer-first Nordic clinical experience. Acta Oncol 56(7):978–983. https://doi.org/10.1080/0284186X.2017.1288923CrossRefPubMed

32.

D’Agostino G, Franzese C, De Rose F et al (2016) High-quality linac-based stereotactic body radiation therapy with flattening filter free beams and volumetric modulated arc therapy for low-intermediate risk prostate cancer. A mono-institutional experience with 90 patients. Clin Oncol 28(12):e173–e178. https://doi.org/10.1016/j.clon.2016.06.013CrossRef

33.

Glowacki G, Majewski W, Wojcieszek P, Grabinska K, Wozniak G, Miszczyk L (2017) Ultrahypofractionated CyberKnifeTM based stereotactic radiotherapy versus conventional radiotherapy in patients with prostate cancer—acute toxicity evaluation in two phase II prospective studies. Neoplasma. https://doi.org/10.4149/neo_2017_421CrossRefPubMed

Title: Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial
Authors: Paul Nguyen
Ludovic Harzée
Paul Retif
Stéphane Joseph
Guillaume Vogin
Philippe Nickers
Publication date: 01-11-2021
Publisher: Springer Berlin Heidelberg
Keywords: Prostate Cancer
Magnetic Resonance Imaging
Magnetic Resonance Imaging
Prostate Cancer
Radiotherapy
Published in: Strahlentherapie und Onkologie / Issue 11/2021
Print ISSN: 0179-7158
Electronic ISSN: 1439-099X
DOI: https://doi.org/10.1007/s00066-021-01832-y

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial

Abstract

Purpose

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 11/2021

Moderately hypofractionated radiotherapy as definitive treatment for localized prostate cancer: Pattern of practice in German-speaking countries

Could pulmonary low-dose radiation therapy be an alternative treatment for patients with COVID-19 pneumonia? Preliminary results of a multicenter SEOR-GICOR nonrandomized prospective trial (IPACOVID trial)

Trimodal therapy with high-dose-rate brachytherapy and hypofractionated external beam radiation combined with long-term androgen deprivation for unfavorable-risk prostate cancer

Patterns of care for prostate cancer radiotherapy—results from a survey among German-speaking radiation oncologists

Neoadjuvante Radiochemotherapie kombiniert mit regionaler Tiefenhyperthermie beim Rektumkarzinom?

Ein neuer Standard zeichnet sich ab: PD-1-Erhaltungstherapie nach neoadjuvanter Radiochemotherapie und kurativer Resektion bei Ösophagus- und AEG-Karzinomen (CheckMate 577)