Oligorecurrent and Oligoprogressive Prostate Cancer Patients Clinical Trial
— IOSCAROfficial title:
Pilot Study of Immune Response Evaluation in Oligorecurrent and Oligoprogressive Prostate Cancer Patients Treated With Metastases-directed Stereotactic Body Radiation Therapy (SBRT) With and Without Concomitant Androgen Deprivation Therapy
NCT number | NCT04624828 |
Other study ID # | 2683 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 19, 2020 |
Est. completion date | December 2024 |
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
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Humanitas Research Hospital | Rozzano | Milano |
Lead Sponsor | Collaborator |
---|---|
Istituto Clinico Humanitas |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | immune evaluation | 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. | from the baseline (before SBRT) to 7 days after the end of radiotherapy treatment | |
Secondary | Progression free survival | Evaluation of Progression free survival (PFS) | 2 years | |
Secondary | Prostate cancer specific survival (PCSS) | Evaluation of Prostate cancer specific survival (PCSS) | 2 years |