Advanced Radiotherapy (ART) in Prostate Cancer (PROST-ART)
- Conditions
- Prostate Cancer
- Interventions
- Radiation: Image Guided RadiotherapyRadiation: Intensity Modulated RadiotherapyRadiation: Stereotactic Body Radiotherapy
- Registration Number
- NCT06546267
- Lead Sponsor
- IRCCS San Raffaele
- Brief 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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 2500
- Prostate cancer patients, > 18 years old, treated with IGRT, IMRT, SBRT
- other tumors
- > 95 years old
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prostate cancer, extensive disease Intensity Modulated Radiotherapy 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 Prostate cancer, localized disease Image Guided Radiotherapy Patients treated with IGRT, IMRT, SBRT, with radical intent for localized prostate cancer will be evaluated Other Names: Intensity Modulated Radiotherapy Stereotactic Body Radiotherapy Prostate cancer, extensive disease Stereotactic Body Radiotherapy 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 Prostate cancer, localized disease Intensity Modulated Radiotherapy Patients treated with IGRT, IMRT, SBRT, with radical intent for localized prostate cancer will be evaluated Other Names: Intensity Modulated Radiotherapy Stereotactic Body Radiotherapy Prostate cancer, localized disease Stereotactic Body Radiotherapy Patients treated with IGRT, IMRT, SBRT, with radical intent for localized prostate cancer will be evaluated Other Names: Intensity Modulated Radiotherapy Stereotactic Body Radiotherapy Prostate cancer, biochemical relapse Stereotactic Body Radiotherapy Patients operated on for prostate cancer and treated with IGRT, IMRT, SBRT for biochemical relapse will be evaluated Prostate cancer, oligometastatic disease ( lymph-nodal, bone, visceral) Image Guided Radiotherapy Prostate cancer patients treated with IGRT, IMRT, SBRT, in radical setting or as salvage radiotherapy for relapse after previous treatments will be evaluated Prostate cancer, extensive disease Image Guided Radiotherapy 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 Prostate cancer, biochemical relapse Image Guided Radiotherapy Patients operated on for prostate cancer and treated with IGRT, IMRT, SBRT for biochemical relapse will be evaluated Prostate cancer, biochemical relapse Intensity Modulated Radiotherapy Patients operated on for prostate cancer and treated with IGRT, IMRT, SBRT for biochemical relapse will be evaluated Prostate cancer, oligometastatic disease ( lymph-nodal, bone, visceral) Intensity Modulated Radiotherapy Prostate cancer patients treated with IGRT, IMRT, SBRT, in radical setting or as salvage radiotherapy for relapse after previous treatments will be evaluated Prostate cancer, oligometastatic disease ( lymph-nodal, bone, visceral) Stereotactic Body Radiotherapy Prostate cancer patients treated with IGRT, IMRT, SBRT, in radical setting or as salvage radiotherapy for relapse after previous treatments will be evaluated
- Primary Outcome Measures
Name Time Method Local Relapse Free Survival 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 Local control of the disease (at the treated site)
Disease Free Survival 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 Absence of disease progression during the follow-up
Regional Relapse Free Survival 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 Regional control of the disease (at the regional lymph node chain)
Distant Metastasis Free Survival 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 Distant Metastasis developed after the treatment
Overall Survival From the date of radiotherapy end until the date of death from any cause, assessed up to 120 months Survival from all causes
Cancer Specific Survival From the date of radiotherapy end until the date of death from disease progression, assessed up to 120 months Cancer Survival
Biochemical relapse free survival 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 Biochemical relapse after the treatment
- Secondary Outcome Measures
Name Time Method Late toxicity From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months 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
Acute Toxicity Up to three months from the start of radiotherapy 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
Trial Locations
- Locations (1)
IRCCS San Raffaele Scientific Institute
🇮🇹Milan, Italy