Prostate Cancer
Conditions
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
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.
Interventions
RADIATIONImage Guided Radiotherapy
Patients treated with IGRT for Prostate cancer will be evaluated
RADIATIONIntensity Modulated Radiotherapy
Patients treated with IMRT for Prostate cancer will be evaluated
RADIATIONStereotactic Body Radiotherapy
Patients treated with SBRT for Prostate cancer will be evaluated
Sponsors
IRCCS San Raffaele
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 95 Years
Inclusion criteria
* Prostate cancer patients, \> 18 years old, treated with IGRT, IMRT, SBRT
Exclusion criteria
* other tumors * \> 95 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cancer Specific Survival | From the date of radiotherapy end until the date of death from disease progression, assessed up to 120 months | Cancer Survival |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Radiomic predictive factors for disease progression and death | From radiotherapy end to the first registered event (disease progression or death), assessed up to 120 months | 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) |
| Predictive factors for disease progression and death | From radiotherapy end to date of local, regional progression, distant failure, or death, assessed up to 120 months | Factors predicting survival. Survival trees, univariate/multivariate Cox regression models will be estimated to identify potential risk factors associated with survival outcomes |
Countries
Italy
Contacts
Primary ContactAndrei Fodor, MD
Backup ContactNadia G Di Muzio, Prof
Outcome results
None listed