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

NCT06546267 | Recruiting

• 1 other identifier: PROST-ART
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

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

Outcome Measures

Primary Outcomes (7)

• Local Relapse Free Survival

  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

  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

  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

  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

  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

  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

  Cancer Survival

  From the date of radiotherapy end until the date of death from disease progression, assessed up to 120 months

Secondary Outcomes (2)

• Acute Toxicity

  Up to three months from the start of radiotherapy

• Late toxicity

  From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months

Other Outcomes (2)

• 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

• 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

Study Arms (4)

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; Radiation: Intensity Modulated Radiotherapy; Radiation: Stereotactic Body 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; Radiation: Intensity Modulated Radiotherapy; Radiation: Stereotactic Body 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; Radiation: Intensity Modulated Radiotherapy; Radiation: Stereotactic Body 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; Radiation: Intensity Modulated Radiotherapy; Radiation: Stereotactic Body Radiotherapy

Interventions

Image Guided Radiotherapy RADIATION

Patients treated with IGRT for Prostate cancer will be evaluated

Also known as: IGRT

Prostate cancer, biochemical relapse; Prostate cancer, extensive disease; Prostate cancer, localized disease; Prostate cancer, oligometastatic disease ( lymph-nodal, bone, visceral)

Intensity Modulated Radiotherapy RADIATION

Patients treated with IMRT for Prostate cancer will be evaluated

Also known as: IMRT

Prostate cancer, biochemical relapse; Prostate cancer, extensive disease; Prostate cancer, localized disease; Prostate cancer, oligometastatic disease ( lymph-nodal, bone, visceral)

Stereotactic Body Radiotherapy RADIATION

Patients treated with SBRT for Prostate cancer will be evaluated

Also known as: SBRT, SRT, SABR (Stereotactic Ablative Radiotherapy)

Prostate cancer, biochemical relapse; Prostate cancer, extensive disease; Prostate cancer, localized disease; Prostate cancer, oligometastatic disease ( lymph-nodal, bone, visceral)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Gender Eligibility Details: Men with prostate cancer
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• other tumors
• \> 95 years old

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

RECRUITING

Related Publications (22)

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MeSH Terms

Conditions

Prostatic Neoplasms; Lymphatic Metastasis

Interventions

Radiotherapy, Image-Guided; Radiotherapy, Intensity-Modulated; Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nadia G Di Muzio, Prof

  IRCCS San Raffaele, Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrei Fodor, MD

CONTACT

+39-0226437634; fodor.andrei@hsr.it

Nadia G Di Muzio, Prof

CONTACT

+39-0226437643; dimuzio.nadia@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: February 14, 2022
• Primary Completion: February 14, 2026
• Study Completion (Estimated): December 14, 2027
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: for another 2 years after the closure of the study
• Access Criteria: Request from the corresponding author approved by the Lombardy Territorial Ethics Committee 1

Locations

IT (1)