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
This is a single-center, retrospective study (PROST-ART) that has as its primary objective the evaluation of the efficacy of radiotherapy treatments performed in patients with early-stage, advanced, metastatic prostate disease, with biochemical relapses after surgery, with local relapses after radiotherapy, or oligometastatic/oligoprogressive disease. The aim of the study is to measure the biochemical relapse-free survival (bRFS), local and regional relapse (LR, regional relapse, RR), distant metastases-free survival (DMS), clinical relapse (DFS), disease-free survival (PCSS), and overall survival (OS) from both disease diagnosis and the end of radiotherapy until the last useful follow-up, or until the patient's death. In addition, the acute and late toxicity of treatments will be assessed from the start of treatment until the last follow-up/death of the patient and the period without other oncological treatments, from the end of treatment until the start of another oncological treatment/last follow-up. 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.
Study Type
OBSERVATIONAL
Enrollment
2,500
Patients treated with IGRT for Prostate cancer will be evaluated
Patients treated with IMRT for Prostate cancer will be evaluated
Patients treated with SBRT for Prostate cancer will be evaluated
IRCCS San Raffaele Scientific Institute
Milan, Italy
RECRUITINGLocal Relapse Free Survival
Local control of the disease (at the treated site)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the date of radiotherapy end until the date of death from any cause, assessed up to 120 months
Cancer Specific Survival
Cancer Survival
Time frame: From the date of radiotherapy end until the date of death from disease progression, assessed up to 120 months
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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
Time frame: 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
Time frame: From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months