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

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Clinico Humanitas
• Treatments: Androgens

Criteria

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