Advanced Radiotherapy (ART) in Prostate Cancer (PROST-ART) (PROST-ART)

June 6, 2025 updated by: Nadia Di Muzio, IRCCS San Raffaele

Efficacy of Advanced Radiotherapy (ART) in Prostate Cancer Patients With Early Stage, Advanced, Metastatic and Relapsed Disease (PROST-ART)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • IRCCS San Raffaele Scientific Institute
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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)

Description

Inclusion Criteria:

  • Prostate cancer patients, > 18 years old, treated with IGRT, IMRT, SBRT

Exclusion Criteria:

  • other tumors
  • > 95 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prostate cancer, localized disease

Patients treated with IGRT, IMRT, SBRT, with radical intent for localized prostate cancer will be evaluated

Other Names:

Intensity Modulated Radiotherapy Stereotactic Body Radiotherapy
Radiation: Image Guided Radiotherapy
Patients treated with IGRT for Prostate cancer will be evaluated
Other Names:
  • IGRT
Radiation: Intensity Modulated Radiotherapy
Patients treated with IMRT for Prostate cancer will be evaluated
Other Names:
  • IMRT
Radiation: Stereotactic Body Radiotherapy
Patients treated with SBRT for Prostate cancer will be evaluated
Other Names:
  • SBRT, SRT, SABR (Stereotactic Ablative Radiotherapy)
Prostate cancer, extensive disease

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
Radiation: Image Guided Radiotherapy
Patients treated with IGRT for Prostate cancer will be evaluated
Other Names:
  • IGRT
Radiation: Intensity Modulated Radiotherapy
Patients treated with IMRT for Prostate cancer will be evaluated
Other Names:
  • IMRT
Radiation: Stereotactic Body Radiotherapy
Patients treated with SBRT for Prostate cancer will be evaluated
Other Names:
  • SBRT, SRT, SABR (Stereotactic Ablative Radiotherapy)
Prostate cancer, biochemical relapse
Patients operated on for prostate cancer and treated with IGRT, IMRT, SBRT for biochemical relapse will be evaluated
Radiation: Image Guided Radiotherapy
Patients treated with IGRT for Prostate cancer will be evaluated
Other Names:
  • IGRT
Radiation: Intensity Modulated Radiotherapy
Patients treated with IMRT for Prostate cancer will be evaluated
Other Names:
  • IMRT
Radiation: Stereotactic Body Radiotherapy
Patients treated with SBRT for Prostate cancer will be evaluated
Other Names:
  • SBRT, SRT, SABR (Stereotactic Ablative Radiotherapy)
Prostate cancer, oligometastatic disease ( lymph-nodal, bone, visceral)
Prostate cancer patients treated with IGRT, IMRT, SBRT, in radical setting or as salvage radiotherapy for relapse after previous treatments will be evaluated
Radiation: Image Guided Radiotherapy
Patients treated with IGRT for Prostate cancer will be evaluated
Other Names:
  • IGRT
Radiation: Intensity Modulated Radiotherapy
Patients treated with IMRT for Prostate cancer will be evaluated
Other Names:
  • IMRT
Radiation: Stereotactic Body Radiotherapy
Patients treated with SBRT for Prostate cancer will be evaluated
Other Names:
  • SBRT, SRT, SABR (Stereotactic Ablative Radiotherapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Relapse Free Survival
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
Local control of the disease (at the treated site)
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
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
Regional control of the disease (at the regional lymph node chain)
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
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
Distant Metastasis developed after the treatment
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
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
Biochemical relapse after the treatment
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
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
Absence of disease progression during the follow-up
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
Time Frame: From the date of radiotherapy end until the date of death from any cause, assessed up to 120 months
Survival from all causes
From the date of radiotherapy end until the date of death from any cause, assessed up to 120 months
Cancer Specific Survival
Time Frame: From the date of radiotherapy end until the date of death from disease progression, assessed up to 120 months
Cancer Survival
From the date of radiotherapy end until the date of death from disease progression, assessed up to 120 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late toxicity
Time Frame: 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
From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months
Acute Toxicity
Time Frame: 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
Up to three months from the start of radiotherapy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive factors for disease progression and death
Time Frame: 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
From radiotherapy end to date of local, regional progression, distant failure, or death, assessed up to 120 months
Radiomic predictive factors for disease progression and death
Time Frame: 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)
From radiotherapy end to the first registered event (disease progression or death), assessed up to 120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Nadia G Di Muzio, Prof, IRCCS San Raffaele, Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2022

Primary Completion (Estimated)

February 14, 2026

Study Completion (Estimated)

December 14, 2027

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2025

Last Update Submitted That Met QC Criteria

June 6, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROST-ART

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data that support the findings of this study (anonymized individual participant data) are available on request from the corresponding author to researchers who provide a methodologically sound proposal. Requests made to the corresponding author (AF) will be evaluated by the Lombardy Territorial Ethics Committee 1.

IPD Sharing Time Frame

for another 2 years after the closure of the study

IPD Sharing Access Criteria

Request from the corresponding author approved by the Lombardy Territorial Ethics Committee 1

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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