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

San Donato Group (GSD)

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: Stereotactic Body Radiotherapy; Radiation: Image Guided Radiotherapy; Radiation: Intensity Modulated Radiotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06546267

PROST-ART

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,500 estimated patients

Sex: Male

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• other tumors
• > 95 years old

Trial design

2,500 participants in 4 patient groups

Prostate cancer, localized disease

Description:

Patients treated with IGRT, IMRT, SBRT, with radical intent for localized prostate cancer will be evaluated Other Names: Intensity Modulated Radiotherapy Stereotactic Body Radiotherapy

Treatment:

Radiation: Intensity Modulated Radiotherapy

Radiation: Image Guided Radiotherapy

Radiation: Stereotactic Body Radiotherapy

Prostate cancer, extensive disease

Description:

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

Treatment:

Radiation: Intensity Modulated Radiotherapy

Radiation: Image Guided Radiotherapy

Radiation: Stereotactic Body Radiotherapy

Prostate cancer, biochemical relapse

Description:

Patients operated on for prostate cancer and treated with IGRT, IMRT, SBRT for biochemical relapse will be evaluated

Treatment:

Radiation: Intensity Modulated Radiotherapy

Radiation: Image Guided Radiotherapy

Radiation: Stereotactic Body Radiotherapy

Prostate cancer, oligometastatic disease ( lymph-nodal, bone, visceral)

Description:

Prostate cancer patients treated with IGRT, IMRT, SBRT, in radical setting or as salvage radiotherapy for relapse after previous treatments will be evaluated

Treatment:

Radiation: Intensity Modulated Radiotherapy

Radiation: Image Guided Radiotherapy

Radiation: Stereotactic Body Radiotherapy