Advanced Radiotherapy (ART) in Prostate Cancer (PROST-ART)
NCT ID: NCT06546267
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2500 participants
OBSERVATIONAL
2022-02-14
2027-12-14
Brief Summary
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Approved by Ethics Committee of IRCCS San Raffaele Hospital Approval Number: 187/INT/2021, 03/02/2022
Amendment approved by Ethics Committee 1, Lombardy Region Approval number CET Em. 194-2024, 22/05/2024
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Detailed Description
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At least 200 patients treated in the last 5 years, some receiving stereotactic radiotherapy to the prostate, or prostate and seminal vesicles, and the others pelvic lymph node and prostate irradiation, who are still alive and contactable, and agree to participate, will be included in a survey on quality of life (QoL). These patients, after signing an informed consent for the collection of new information, will receive an EORTC QLQ-PR25 quality of life questionnaire, in order to quantify the impact of toxicity. In addition, the radiomic characteristics of the computed tomography/ PET-CT performed for treatment planning along with evaluation of the results will be extracted to identify related predictive factors.
The QoL study is configured as retrospective as the questionnaire will only be an expression, from the patient's point of view, of the toxicity of the previous treatment.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Prostate cancer, localized disease
Patients treated with IGRT, IMRT, SBRT, with radical intent for localized prostate cancer will be evaluated
Other Names:
Intensity Modulated Radiotherapy Stereotactic Body Radiotherapy
Image Guided Radiotherapy
Patients treated with IGRT for Prostate cancer will be evaluated
Intensity Modulated Radiotherapy
Patients treated with IMRT for Prostate cancer will be evaluated
Stereotactic Body Radiotherapy
Patients treated with SBRT for Prostate cancer will be evaluated
Prostate cancer, extensive disease
Patients operated on for prostate cancer, treated with IGRT, IMRT, SBRT in adjuvant setting will be evaluated
Other Names:
Intensity Modulated Radiotherapy Stereotactic Body Radiotherapy
Image Guided Radiotherapy
Patients treated with IGRT for Prostate cancer will be evaluated
Intensity Modulated Radiotherapy
Patients treated with IMRT for Prostate cancer will be evaluated
Stereotactic Body Radiotherapy
Patients treated with SBRT for Prostate cancer will be evaluated
Prostate cancer, biochemical relapse
Patients operated on for prostate cancer and treated with IGRT, IMRT, SBRT for biochemical relapse will be evaluated
Image Guided Radiotherapy
Patients treated with IGRT for Prostate cancer will be evaluated
Intensity Modulated Radiotherapy
Patients treated with IMRT for Prostate cancer will be evaluated
Stereotactic Body Radiotherapy
Patients treated with SBRT for Prostate cancer will be evaluated
Prostate cancer, oligometastatic disease ( lymph-nodal, bone, visceral)
Prostate cancer patients treated with IGRT, IMRT, SBRT, in radical setting or as salvage radiotherapy for relapse after previous treatments will be evaluated
Image Guided Radiotherapy
Patients treated with IGRT for Prostate cancer will be evaluated
Intensity Modulated Radiotherapy
Patients treated with IMRT for Prostate cancer will be evaluated
Stereotactic Body Radiotherapy
Patients treated with SBRT for Prostate cancer will be evaluated
Interventions
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Image Guided Radiotherapy
Patients treated with IGRT for Prostate cancer will be evaluated
Intensity Modulated Radiotherapy
Patients treated with IMRT for Prostate cancer will be evaluated
Stereotactic Body Radiotherapy
Patients treated with SBRT for Prostate cancer will be evaluated
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* \> 95 years old
18 Years
95 Years
MALE
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Nadia Di Muzio
Professor
Principal Investigators
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Nadia G Di Muzio, Prof
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele, Milan
Locations
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IRCCS San Raffaele Scientific Institute
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
Hamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, Davis M, Peters TJ, Turner EL, Martin RM, Oxley J, Robinson M, Staffurth J, Walsh E, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Neal DE; ProtecT Study Group. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1415-1424. doi: 10.1056/NEJMoa1606220. Epub 2016 Sep 14.
Parker CC, James ND, Brawley CD, Clarke NW, Hoyle AP, Ali A, Ritchie AWS, Attard G, Chowdhury S, Cross W, Dearnaley DP, Gillessen S, Gilson C, Jones RJ, Langley RE, Malik ZI, Mason MD, Matheson D, Millman R, Russell JM, Thalmann GN, Amos CL, Alonzi R, Bahl A, Birtle A, Din O, Douis H, Eswar C, Gale J, Gannon MR, Jonnada S, Khaksar S, Lester JF, O'Sullivan JM, Parikh OA, Pedley ID, Pudney DM, Sheehan DJ, Srihari NN, Tran ATH, Parmar MKB, Sydes MR; Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators. Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial. Lancet. 2018 Dec 1;392(10162):2353-2366. doi: 10.1016/S0140-6736(18)32486-3. Epub 2018 Oct 21.
Donovan JL, Hamdy FC, Lane JA, Mason M, Metcalfe C, Walsh E, Blazeby JM, Peters TJ, Holding P, Bonnington S, Lennon T, Bradshaw L, Cooper D, Herbert P, Howson J, Jones A, Lyons N, Salter E, Thompson P, Tidball S, Blaikie J, Gray C, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Davis M, Turner EL, Martin RM, Neal DE; ProtecT Study Group*. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1425-1437. doi: 10.1056/NEJMoa1606221. Epub 2016 Sep 14.
Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. 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. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20.
Catton CN, Lukka H, Gu CS, Martin JM, Supiot S, Chung PWM, Bauman GS, Bahary JP, Ahmed S, Cheung P, Tai KH, Wu JS, Parliament MB, Tsakiridis T, Corbett TB, Tang C, Dayes IS, Warde P, Craig TK, Julian JA, Levine MN. Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer. J Clin Oncol. 2017 Jun 10;35(17):1884-1890. doi: 10.1200/JCO.2016.71.7397. Epub 2017 Mar 15.
Incrocci L, Wortel RC, Alemayehu WG, Aluwini S, Schimmel E, Krol S, van der Toorn PP, Jager H, Heemsbergen W, Heijmen B, Pos F. Hypofractionated versus conventionally fractionated radiotherapy for patients with localised prostate cancer (HYPRO): final efficacy results from a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1061-1069. doi: 10.1016/S1470-2045(16)30070-5. Epub 2016 Jun 20.
Lee WR, Dignam JJ, Amin MB, Bruner DW, Low D, Swanson GP, Shah AB, D'Souza DP, Michalski JM, Dayes IS, Seaward SA, Hall WA, Nguyen PL, Pisansky TM, Faria SL, Chen Y, Koontz BF, Paulus R, Sandler HM. Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer. J Clin Oncol. 2016 Jul 10;34(20):2325-32. doi: 10.1200/JCO.2016.67.0448. Epub 2016 Apr 4.
Pollack A, Walker G, Horwitz EM, Price R, Feigenberg S, Konski AA, Stoyanova R, Movsas B, Greenberg RE, Uzzo RG, Ma C, Buyyounouski MK. Randomized trial of hypofractionated external-beam radiotherapy for prostate cancer. J Clin Oncol. 2013 Nov 1;31(31):3860-8. doi: 10.1200/JCO.2013.51.1972. Epub 2013 Oct 7.
Widmark A, Gunnlaugsson A, Beckman L, Thellenberg-Karlsson C, Hoyer M, Lagerlund M, Kindblom J, Ginman C, Johansson B, Bjornlinger K, Seke M, Agrup M, Fransson P, Tavelin B, Norman D, Zackrisson B, Anderson H, Kjellen E, Franzen L, Nilsson P. Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. Lancet. 2019 Aug 3;394(10196):385-395. doi: 10.1016/S0140-6736(19)31131-6. Epub 2019 Jun 18.
Parker CC, Clarke NW, Cook AD, Kynaston HG, Petersen PM, Catton C, Cross W, Logue J, Parulekar W, Payne H, Persad R, Pickering H, Saad F, Anderson J, Bahl A, Bottomley D, Brasso K, Chahal R, Cooke PW, Eddy B, Gibbs S, Goh C, Gujral S, Heath C, Henderson A, Jaganathan R, Jakobsen H, James ND, Kanaga Sundaram S, Lees K, Lester J, Lindberg H, Money-Kyrle J, Morris S, O'Sullivan J, Ostler P, Owen L, Patel P, Pope A, Popert R, Raman R, Roder MA, Sayers I, Simms M, Wilson J, Zarkar A, Parmar MKB, Sydes MR. Timing of radiotherapy after radical prostatectomy (RADICALS-RT): a randomised, controlled phase 3 trial. Lancet. 2020 Oct 31;396(10260):1413-1421. doi: 10.1016/S0140-6736(20)31553-1. Epub 2020 Sep 28.
Kneebone A, Fraser-Browne C, Duchesne GM, Fisher R, Frydenberg M, Herschtal A, Williams SG, Brown C, Delprado W, Haworth A, Joseph DJ, Martin JM, Matthews JHL, Millar JL, Sidhom M, Spry N, Tang CI, Turner S, Wiltshire KL, Woo HH, Davis ID, Lim TS, Pearse M. Adjuvant radiotherapy versus early salvage radiotherapy following radical prostatectomy (TROG 08.03/ANZUP RAVES): a randomised, controlled, phase 3, non-inferiority trial. Lancet Oncol. 2020 Oct;21(10):1331-1340. doi: 10.1016/S1470-2045(20)30456-3.
Vale CL, Fisher D, Kneebone A, Parker C, Pearse M, Richaud P, Sargos P, Sydes MR, Brawley C, Brihoum M, Brown C, Chabaud S, Cook A, Forcat S, Fraser-Browne C, Latorzeff I, Parmar MKB, Tierney JF; ARTISTIC Meta-analysis Group. Adjuvant or early salvage radiotherapy for the treatment of localised and locally advanced prostate cancer: a prospectively planned systematic review and meta-analysis of aggregate data. Lancet. 2020 Oct 31;396(10260):1422-1431. doi: 10.1016/S0140-6736(20)31952-8. Epub 2020 Sep 28.
Ost P, Reynders D, Decaestecker K, Fonteyne V, Lumen N, De Bruycker A, Lambert B, Delrue L, Bultijnck R, Claeys T, Goetghebeur E, Villeirs G, De Man K, Ameye F, Billiet I, Joniau S, Vanhaverbeke F, De Meerleer G. Surveillance or Metastasis-Directed Therapy for Oligometastatic Prostate Cancer Recurrence: A Prospective, Randomized, Multicenter Phase II Trial. J Clin Oncol. 2018 Feb 10;36(5):446-453. doi: 10.1200/JCO.2017.75.4853. Epub 2017 Dec 14.
Di Muzio NG, Fodor A, Noris Chiorda B, Broggi S, Mangili P, Valdagni R, Dell'Oca I, Pasetti M, Deantoni CL, Chiara A, Berardi G, Briganti A, Calandrino R, Cozzarini C, Fiorino C. Moderate Hypofractionation with Simultaneous Integrated Boost in Prostate Cancer: Long-term Results of a Phase I-II Study. Clin Oncol (R Coll Radiol). 2016 Aug;28(8):490-500. doi: 10.1016/j.clon.2016.02.005. Epub 2016 Mar 5.
Cozzarini C, Fiorino C, Di Muzio N, Alongi F, Broggi S, Cattaneo M, Montorsi F, Rigatti P, Calandrino R, Fazio F. Significant reduction of acute toxicity following pelvic irradiation with helical tomotherapy in patients with localized prostate cancer. Radiother Oncol. 2007 Aug;84(2):164-70. doi: 10.1016/j.radonc.2007.07.013. Epub 2007 Aug 13.
Fodor A, Fiorino C, Picchio M, Di Muzio N. Re: Daniel E. Spratt, Herbert A. Vargas, Zachary S. Zumsteg, et al. Patterns of Lymph Node Failure after Dose-escalated Radiotherapy: Implications for Extended Pelvic Lymph Node Coverage. Eur Urol 2017;71;37-43: High-dose Radiotherapy and Pelvic Lymph Nodal Irradiation for High-risk Prostate Cancer in the Image-guided Radiotherapy Era. Eur Urol. 2017 Jun;71(6):e179-e180. doi: 10.1016/j.eururo.2016.12.021. Epub 2017 Jan 5. No abstract available.
Di Muzio N, Fiorino C, Cozzarini C, Alongi F, Broggi S, Mangili P, Guazzoni G, Valdagni R, Calandrino R, Fazio F. Phase I-II study of hypofractionated simultaneous integrated boost with tomotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2009 Jun 1;74(2):392-8. doi: 10.1016/j.ijrobp.2008.08.038. Epub 2008 Dec 4.
Fiorino C, Di Muzio N, Broggi S, Cozzarini C, Maggiulli E, Alongi F, Valdagni R, Fazio F, Calandrino R. Evidence of limited motion of the prostate by carefully emptying the rectum as assessed by daily MVCT image guidance with helical tomotherapy. Int J Radiat Oncol Biol Phys. 2008 Jun 1;71(2):611-7. doi: 10.1016/j.ijrobp.2008.01.048. Epub 2008 Apr 18.
Cozzarini C, Fiorino C, Deantoni C, Briganti A, Fodor A, La Macchia M, Noris Chiorda B, Rancoita PM, Suardi N, Zerbetto F, Calandrino R, Montorsi F, Di Muzio N. Higher-than-expected severe (Grade 3-4) late urinary toxicity after postprostatectomy hypofractionated radiotherapy: a single-institution analysis of 1176 patients. Eur Urol. 2014 Dec;66(6):1024-30. doi: 10.1016/j.eururo.2014.06.012. Epub 2014 Jun 27.
Fodor A, Berardi G, Fiorino C, Picchio M, Busnardo E, Kirienko M, Incerti E, Dell'Oca I, Cozzarini C, Mangili P, Pasetti M, Calandrino R, Gianolli L, Di Muzio NG. Toxicity and efficacy of salvage carbon 11-choline positron emission tomography/computed tomography-guided radiation therapy in patients with lymph node recurrence of prostate cancer. BJU Int. 2017 Mar;119(3):406-413. doi: 10.1111/bju.13510. Epub 2016 May 24.
Deantoni CL, Fodor A, Cozzarini C, Fiorino C, Brombin C, Di Serio C, Calandrino R, Di Muzio N. Prostate cancer with low burden skeletal disease at diagnosis: outcome of concomitant radiotherapy on primary tumor and metastases. Br J Radiol. 2020 Apr;93(1108):20190353. doi: 10.1259/bjr.20190353. Epub 2020 Jan 31.
Other Identifiers
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PROST-ART
Identifier Type: -
Identifier Source: org_study_id
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