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

Last updated: August 6, 2024
Sponsor: IRCCS San Raffaele
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer, Early, Recurrent

Prostate Cancer

Urologic Cancer

Treatment

Intensity Modulated Radiotherapy

Image Guided Radiotherapy

Stereotactic Body Radiotherapy

Clinical Study ID

NCT06546267
PROST-ART
  • Ages 18-95
  • Male

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • other tumors

  • > 95 years old

Study Design

Total Participants: 2500
Treatment Group(s): 3
Primary Treatment: Intensity Modulated Radiotherapy
Phase:
Study Start date:
February 14, 2022
Estimated Completion Date:
December 14, 2027

Study 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.

Connect with a study center

  • IRCCS San Raffaele Scientific Institute

    Milan, 20132
    Italy

    Active - Recruiting

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