Prostate Stereotactic Radiation and Radio-induced Lymphocyte Apoptosis for Predicting Late Toxicities in Prostate Cancer (PROSTERA)

NCT07145437 | Not Yet Recruiting

• 1 other identifier: 2025-A00340-49
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

This monocentric interventional study investigates whether the Radio-induced Lymphocyte Apoptosis (RILA) assay can predict the occurrence of late radiation-induced toxicities in patients with localized prostate cancer treated with stereotactic body radiotherapy (SBRT). Eligible patients will undergo a peripheral blood sample collection for the RILA test prior to SBRT. Toxicities will be assessed using CTCAE v5.0 criteria, and quality of life will be evaluated with EORTC QLQ-PR25, QLQ-C30, and IPSS questionnaires over a 60-month follow-up. The results aim to optimize patient selection for SBRT and reduce the risk of severe late side effects.

Conditions

Prostate Cancer

Keywords

Stereotactic Body Radiotherapy; Late Toxicity; RILA; Predictive Biomarker; Prostate cancer

Outcome Measures

Primary Outcomes (1)

• Occurrence of one or more late radiation-induced complications

  Number of participants presenting one or more late radiation-induced complications, assessed using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

  24 months post-stereotactic radiotherapy

Secondary Outcomes (6)

• Mortality rate of T-CD8+/-CD4+ lymphocytes

  After in vitro culture and irradiation at 8 Gy

• Clinical and biological variables of patients

  At baseline and during follow-up (up to 60 months post-radiotherapy)

• Quality of life - EORTC QLQ-PR25

  Baseline, 1, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months post-radiotherapy

• Quality of life - EORTC QLQ-C30

  Baseline, 1, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months post-radiotherapy

• Urinary symptoms - International Prostate Symptom Score (IPSS)

  Baseline, 1, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months post-radiotherapy

Study Arms (1)

Experimental: SBRT + RILA assay (single-arm)

EXPERIMENTAL

All participants assigned to this single experimental arm will receive stereotactic body radiotherapy (SBRT) to the prostate delivered according to the PROSTERA protocol with predefined dose prescription and organ-at-risk constraints. A single peripheral blood sample (2 mL, lithium-heparin) will be collected at the time of CT simulation for the Radio-induced Lymphocyte Apoptosis (RILA) assay. Samples are transported and processed at the designated laboratory (LIRS) and handled per the RILA SOP: processing within 4 hours of collection, incubation 16-24 hours, ex-vivo irradiation (8 Gy), further incubation 48 hours, staining for CD4/CD8 and propidium iodide, and flow cytometry analysis (10,000 events, measured in triplicate) to quantify apoptotic T-lymphocytes. RILA results will be used for correlative and prognostic analyses versus late genitourinary and gastrointestinal toxicities (CTCAE v5.0), PSA kinetics and patient-reported outcomes (EORTC QLQ-PR25, QLQ-C30, IPSS).

Diagnostic Test: Radio-induced Lymphocyte Apoptosis (RILA) Assay; Radiation: Stereotactic body radiotherapy (SBRT)

Interventions

Stereotactic body radiotherapy (SBRT) RADIATION

SBRT delivered to the prostate with image guidance, respecting dose constraints for organs at risk;

Experimental: SBRT + RILA assay (single-arm)

Radio-induced Lymphocyte Apoptosis (RILA) Assay DIAGNOSTIC_TEST

peripheral blood sample processed via the RILA assay to quantify apoptotic CD8+/CD4+ T cells following ex vivo irradiation.

Experimental: SBRT + RILA assay (single-arm)

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: Adult male patients with localized prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, aged 60 years or older, presenting with localized prostate cancer of low or intermediate risk (T1-T2 stage, Gleason score 6-7, and PSA \<15 ng/mL) without metastatic disease, and for whom radiotherapy is indicated.
• Patient affiliated with, or beneficiary of, the French national health insurance system.
• French-speaking patient.
• Patient who has been informed about the study and has provided written informed consent.

You may not qualify if:

• Patient unable to read, write, or understand French.
• Vulnerable patient as defined in Article L1121-6 of the French Public Health Code.
• Adult under legal guardianship, curatorship, or judicial protection.
• Patient unable to personally provide informed consent as per Article L1121-8 of the French Public Health Code, or adult protected by law.
• Patient already enrolled in an interventional study that could influence the outcomes of the present study.
• Patient with a history of prostate and/or digestive surgery.

Sponsors & Collaborators

• Clinique Sainte Clotilde: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mickael DR Begue, Doctor

  Clinique Sainte Clotilde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manon LEPRINCE, Clinical Research Associate

CONTACT

+262692341365; manon.leprince@clinifutur.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 28, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2030
• Last Updated: March 18, 2026

Record last verified: 2026-03