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NCT07145437Not yet recruiting

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

Evaluation of the Prognostic Value of Radio-induced Lymphocyte Apoptosis for Predicting Late Radiation-induced Toxicities After Stereotactic Body Radiotherapy in Patients With Localized Prostate Cancer

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
220 (estimated)
First submitted
11 Aug 2025
Start date
1 Feb 2027
Primary completion date
1 Nov 2027
Lead sponsor
Clinique Sainte Clotilde
NCT number
NCT07145437

What you commit to

  • Study type: Interventional
  • Planned participants: 220
  • From 1 Feb 2027 to the primary completion date, 1 Nov 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patient with a history of prostate and/or digestive surgery.

Other

  • 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.
  • Refusal to sign the written informed consent at inclusion.

Who the study is looking for

  • 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.

Age in the registry: 60 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.