Clinical trial · Observational

Advanced Radiotherapy (ART) in Prostate Cancer (PROST-ART)

Efficacy of Advanced Radiotherapy (ART) in Prostate Cancer Patients With Early Stage, Advanced, Metastatic and Relapsed Disease (PROST-ART)

NCT06546267CI-TRIAL-00090897PROST-ARTrecruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This is a retrospective monoinstitutional study which analyses the results of advanced radiotherapy (IGRT, IMRT, SBRT, and PET-guided) performed for radical, adjuvant, or salvage purposes in patients with low, intermediate, high, and very high-risk prostate cancer, or with biochemical, lymph node, or oligometastatic recurrence treated between 2004 and 2024. 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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Image Guided Radiotherapy	Radiation	—	UNRESOLVED
Intensity Modulated Radiotherapy	Radiation	—	UNRESOLVED
Stereotactic Body Radiotherapy	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (4)

label
Prostate cancer, localized disease
description
Patients treated with IGRT, IMRT, SBRT, with radical intent for localized prostate cancer will be evaluated Other Names: Intensity Modulated Radiotherapy Stereotactic Body Radiotherapy
interventionNames
1. Radiation: Image Guided Radiotherapy
2. Radiation: Intensity Modulated Radiotherapy
3. Radiation: Stereotactic Body Radiotherapy
label
Prostate cancer, extensive disease
description
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
interventionNames
1. Radiation: Image Guided Radiotherapy
2. Radiation: Intensity Modulated Radiotherapy
3. Radiation: Stereotactic Body Radiotherapy
label
Prostate cancer, biochemical relapse
description

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 18 Years
Maximum age: 95 Years

Show eligibility criteria text

Inclusion Criteria:

* Prostate cancer patients, \> 18 years old, treated with IGRT, IMRT, SBRT

Exclusion Criteria:

* other tumors
* \> 95 years old

References

Publications (22)

RESULTBray 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. PMID 30207593
RESULTHamdy 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. PMID 27626136
RESULTParker 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. PMID 30355464
RESULTDonovan 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. PMID 27626365

Registry

Dates and enrollment

Start: Feb 14, 2022
Primary completion: Feb 14, 2026
Completion: Dec 14, 2027
First posted: Aug 9, 2024
Last update posted: Jun 11, 2025
Enrollment: 2,500 (estimated)
Lead sponsor: IRCCS San Raffaele OTHER
Keywords: Prostate Cancer, Radical Radiotherapy, Adjuvant Radiotherapy, Salvage Radiotherapy, Stereotactic Body Radiotherapy (SBRT), Simultaneous Integrated Boost, Oligometastatic Disease, Bone Metastases, Lymph-Node Metastases, Choline PET/CT, PSMA PET/CT, PET guidance

Data updated 22 days agoSource updated Jun 11, 2025source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
Italy	1	1

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.