Clinical trial NCT06546267: Advanced Radiotherapy (ART) in Prostate Cancer (PROST-ART)
Official title: Efficacy of Advanced Radiotherapy (ART) in Prostate Cancer Patients With Early Stage, Advanced, Metastatic and Relapsed Disease (PROST-ART)
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 2500
Sex: MALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* other tumors
* \> 95 years old

Primary outcomes:
measure: Local Relapse Free Survival
timeFrame: 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
measure: Regional Relapse Free Survival
timeFrame: 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
measure: Distant Metastasis Free Survival
timeFrame: 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
measure: Biochemical relapse free survival
timeFrame: 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
measure: Disease Free Survival
timeFrame: 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
measure: Overall Survival
timeFrame: From the date of radiotherapy end until the date of death from any cause, assessed up to 120 months
measure: Cancer Specific Survival
timeFrame: From the date of radiotherapy end until the date of death from disease progression, assessed up to 120 months
Secondary outcomes:
measure: Acute Toxicity
timeFrame: Up to three months from the start of radiotherapy
measure: Late toxicity
timeFrame: From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months
Other outcomes:
measure: Predictive factors for disease progression and death
timeFrame: From radiotherapy end to date of local, regional progression, distant failure, or death, assessed up to 120 months
measure: Radiomic predictive factors for disease progression and death
timeFrame: From radiotherapy end to the first registered event (disease progression or death), assessed up to 120 months
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Scientific Institute
Study officials:
affiliation: IRCCS San Raffaele, Milan
name: Nadia G Di Muzio, Prof
role: PRINCIPAL_INVESTIGATOR
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