Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546267
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Advanced Radiotherapy ART in Prostate Cancer PROST-ART
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Advanced Radiotherapy ART in Prostate Cancer Patients With Early Stage Advanced Metastatic and Relapsed Disease PROST-ART
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROST-ART
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 187INT2021 03022022
Amendment approved by Ethics Committee 1 Lombardy Region Approval number CET Em 194-2024 22052024
Approved by Ethics Committee of IRCCS San Raffaele Hospital Approval Number 187INT2021 03022022
Amendment approved by Ethics Committee 1 Lombardy Region Approval number CET Em 194-2024 22052024
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 oligometastaticoligoprogressive 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 patients death In addition the acute and late toxicity of treatments will be assessed from the start of treatment until the last follow-updeath of the patient and the period without other oncological treatments from the end of treatment until the start of another oncological treatmentlast 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 patients point of view of the toxicity of the previous treatment
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 patients point of view of the toxicity of the previous treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None