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Clinical Trials in Italy / NCT04624828
Active, not recruiting Not applicable

Immune Response Evaluation in Oligorecurrent and Oligoprogressive Prostate Cancer Patients Treated With SBRT

NCT04624828 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Clinico Humanitas
Phase
Not applicable
Started
2020-10-19
Last updated
2025-04-24

Condition(s) studied

Oligorecurrent and Oligoprogressive Prostate Cancer Patients

Investigational drug(s) / intervention(s)

Radiotherapyandrogen deprivation therapy (ADT)immune evaluation

Radiotherapy: RT treatment Schedule as for clinical practice: Stereotactic body radiation treatment (SBRT) will be delivered with image guidance (image-guided radiation therapy or IGRT) and in the form of volumetric modulated arc therapy (VMAT). RT treatment Schedule: SBRT will be delivered in 1 to 6 fractions on bone or lymph node metastases. The dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints.

androgen deprivation therapy (ADT): ADT as for clinical practice: * for oligorecurrent patients, ADT will be started at time of polimetastatic progression after SBRT; * for oligoprogressive patients, ADT will be continued during SBRT and untill polimetastatic progression

immune evaluation: We will use the flow cytometer FACSymphony, to analyse multiple immune populations from a limited sample of blood. We will monitor the dynamics of most innate (monocytic and granulocytic cells, Natural killer cells) and adaptive (T cells, B cells) immune subsets in the peripheral blood of PC patients before and after RT. We will deeply characterize CD4+ and CD8+ T cell subpopulations circulating in the patients enrolled in the study. In this attempt our panel will include markers of T cell differentiation and activation, including CD25, CD39, PD-1, CTL4, KLRG1, TIM3. We will analyse neutrophils subpopulations and investigate the functional profile of granulocytes in enrolled patients. Markers such as CD66b, CD24, CD16, MHC-II, LOX1, CD36 and CD62L will be included in our analysis. In conclusion our experimental strategy will result in a comprehensive profiling of the immune landscape in PC patients at single cell level.

Study summary

At the moment there is a lack of data in the setting of oligometastatic PC in particular regarding the interaction between ablative SBRT, ADT and patient's immune system response.

The hypothesis underlying this project consists in the idea that the patient's immunological context, RT and ADT may interact in the context of metastatic PC. Indeed the immune landscape of patients may interfere with the efficacy of SBRT and on the other side RT may modulate the immune response by driving immunotolerance.

Scope of the study will be to investigate the immune modulation after SBRT in:

* patients with diagnosis of oligorecurrence during a treatment-free interval
* patients with oligoprogression or oligopersistance during hormonal therapy

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18years * Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures * Adenocarcinoma of the prostate treated with radical prostatectomy or radical RT * Diagnosis of 1 to 3 metachronous metastases to bone or lymph nodes or oligoprogression / oligopersistance during ADT of a maximum of 3 metastases in bone or lymph nodes * ECOG performance status of 0 - 1 * Informed consent. Exclusion Criteria: * Visceral metastases * Evidence of spinal cord compression (radiological or clinical) * Concurrent malignancy * Inability to undergo RT * History of inflammatory colitis or other active severe comorbidities * Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications * Life expectancy \<6 months

Primary outcome measure(s)

  • immune evaluation — from the baseline (before SBRT) to 7 days after the end of radiotherapy treatment
    Analysis of the immunitary background performed before SBRT and evaluation of immune modulation after RT treatment. Our panels will include markers of T cell differentiation and activation, including CD25, CD39, PD-1, CTL4, KLRG1, TIM3, TIGIT. In addition we will investigate the phenotype and functional state of myeloid subsets in enrolled patients, comprising neutrophils, monocytes and dendritic cells. To this end, markers such as CD66b, CD24, CD16, MHC-II, LOX1, CD36 and CD62L will be included in our analysis.

Trial sites (1)

FacilityCityRegionStatus
Humanitas Research Hospital Rozzano Milano

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04624828 on ClinicalTrials.gov ↗ ← All trials in Italy