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NCT Number: NCT06546267

Advanced Radiotherapy (ART) in Prostate Cancer (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

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Key information

Conditions

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

Age range

18 year–95 year

Sex eligibility

Male

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • other tumors
  • > 95 years old

Treatment and study plan

Image guided radiotherapy

Radiation

Patients treated with IGRT for Prostate cancer will be evaluated

Other names: IGRT

Intensity modulated radiotherapy

Radiation

Patients treated with IMRT for Prostate cancer will be evaluated

Other names: IMRT

stereotactic body radiotherapy

Radiation

Patients treated with SBRT for Prostate cancer will be evaluated

Other names: SBRT, SRT, SABR (Stereotactic Ablative Radiotherapy)

Primary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. 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

  2. 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

Other outcomes

  1. 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

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Andrei Fodor, MD

CONTACT

[email protected]

+39-0226437634

Nadia G Di Muzio, Prof

CONTACT

[email protected]

+39-0226437643

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Acronym: PROST-ART

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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