Advanced Radiotherapy (ART) in Prostate Cancer (PROST-ART)
NCT Number: NCT06546267
Acronym: PROST-ART
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Interventions: RADIATION: Image Guided Radiotherapy|RADIATION: Intensity Modulated Radiotherapy|RADIATION: Stereotactic Body Radiotherapy
Sponsor: IRCCS San Raffaele
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 2500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-02-14
Completion Date: 2027-12-14
Locations: IRCCS San Raffaele Scientific Institute, Milan, 20132, Italy

Summary:
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

Primary Outcome Measures: Local Relapse Free Survival, Local control of the disease (at the treated site), From the date of radiotherapy end until the date of local progression or date of death from any cause, whichever came first, assessed up to 120 months|Regional Relapse Free Survival, Regional control of the disease (at the regional lymph node chain), From the date of radiotherapy end until the date of regional progression or date of death from any cause, whichever came first, assessed up to 120 months|Distant Metastasis Free Survival, Distant Metastasis developed after the treatment, From the date of radiotherapy end until the date of distant progression or date of death from any cause, whichever came first, assessed up to 120 months|Biochemical relapse free survival, Biochemical relapse after the treatment, From the date of radiotherapy end until the date of biochemical progression or date of death from any cause, whichever came first, assessed up to 120 months|Disease Free Survival, Absence of disease progression during the follow-up, From the date of radiotherapy end until the date of first documented clinical progression or date of death from any cause, whichever came first, assessed up to 120 months|Overall Survival, Survival from all causes, From the date of radiotherapy end until the date of death from any cause, assessed up to 120 months|Cancer Specific Survival, Cancer Survival, From the date of radiotherapy end until the date of death from disease progression, assessed up to 120 months
Secondary Outcome Measures: Acute Toxicity, Toxicity developed in the first three months after the treatment, assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale, which displayes grades from 1 to 5, with grade 1 meaning mild toxicity and grade 5 death related to toxicity, Up to three months from the start of radiotherapy|Late toxicity, Toxicity developed after three months until the end of follow-up or death, assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale, assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale, which displayes grades from 1 to 5, with grade 1 meaning mild toxicity and grade 5 death related to toxicity, From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months
Other Outcome Measures: Predictive factors for disease progression and death, Factors predicting survival. Survival trees, univariate/multivariate Cox regression models will be estimated to identify potential risk factors associated with survival outcomes, From radiotherapy end to date of local, regional progression, distant failure, or death, assessed up to 120 months|Radiomic predictive factors for disease progression and death, CT and PET/CT radiomic features predicting relapse or death will be extracted, acording to IBSI (Image Biomarker Standardisation Initiative), owning to the different families of features: Morphology, Statistical, Intensity Histogram, Grey Level Cooccurrence Matrix 3D-average, Grey Level Co-occurrence Matrix 3D-combined, Grey Level Run Lenght 3D-average. Grey Level Run Lenght 3D_combined, Grey Level Size Zone Matrix 3D, Neighbors Grey Tone Difference Matrix 3D, Grey Level Distance Zone Matrix 3D, standard convolutional filters within radiomic workflow (wavelets, Laplacian of Gaussian), From radiotherapy end to the first registered event (disease progression or death), assessed up to 120 months