Trial Title:
Advanced Radiotherapy (ART) in Prostate Cancer (PROST-ART)
NCT ID:
NCT06546267
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
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
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Radiation
Intervention name:
Image Guided Radiotherapy
Description:
Patients treated with IGRT for Prostate cancer will be evaluated
Arm group label:
Prostate cancer, biochemical relapse
Arm group label:
Prostate cancer, extensive disease
Arm group label:
Prostate cancer, localized disease
Arm group label:
Prostate cancer, oligometastatic disease ( lymph-nodal, bone, visceral)
Other name:
IGRT
Intervention type:
Radiation
Intervention name:
Intensity Modulated Radiotherapy
Description:
Patients treated with IMRT for Prostate cancer will be evaluated
Arm group label:
Prostate cancer, biochemical relapse
Arm group label:
Prostate cancer, extensive disease
Arm group label:
Prostate cancer, localized disease
Arm group label:
Prostate cancer, oligometastatic disease ( lymph-nodal, bone, visceral)
Other name:
IMRT
Intervention type:
Radiation
Intervention name:
Stereotactic Body Radiotherapy
Description:
Patients treated with SBRT for Prostate cancer will be evaluated
Arm group label:
Prostate cancer, biochemical relapse
Arm group label:
Prostate cancer, extensive disease
Arm group label:
Prostate cancer, localized disease
Arm group label:
Prostate cancer, oligometastatic disease ( lymph-nodal, bone, visceral)
Other name:
SBRT, SRT, SABR (Stereotactic Ablative Radiotherapy)
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.
Criteria for eligibility:
Study pop:
Prostate cancer patients with early-stage, advanced, metastatic prostate disease, with
biochemical relapses after surgery, with local relapses after radiotherapy, or
oligometastatic/oligoprogressive disease (lymph nodes, bone, visceral)
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Prostate cancer patients, > 18 years old, treated with IGRT, IMRT, SBRT
Exclusion Criteria:
- other tumors
- > 95 years old
Gender:
Male
Gender based:
Yes
Gender description:
Men with prostate cancer
Minimum age:
18 Years
Maximum age:
95 Years
Locations:
Facility:
Name:
IRCCS San Raffaele Scientific Institute
Address:
City:
Milan
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Andrei Fodor, MD
Phone:
+390226437634
Email:
fodor.andrei@hsr.it
Contact backup:
Last name:
Nadia G Di Muzio, Prof
Phone:
+390226437643
Email:
dimuzio.nadia@hsr.it
Start date:
February 14, 2022
Completion date:
December 14, 2027
Lead sponsor:
Agency:
IRCCS San Raffaele
Agency class:
Other
Source:
IRCCS San Raffaele
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06546267
