NCT04624828Active, not recruiting
Immune Response Evaluation in Oligorecurrent and Oligoprogressive Prostate Cancer Patients Treated With SBRT
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
Source: ClinicalTrials.gov · Last updated 24 Apr 2025
Brief summary (registry, in English)
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 (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 2 Nov 2020
- Start date
- 19 Oct 2020
- Primary completion date
- Jul 2026
- Lead sponsor
- Istituto Clinico Humanitas
- Diseases
- Prostate cancer
- NCT number
- NCT04624828
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 19 Oct 2020 to the primary completion date, Jul 2026
- 1 site in 1 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.
Prior treatment
- Concurrent malignancy
Other illness
- 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
Other
- Visceral metastases
- Evidence of spinal cord compression (radiological or clinical)
- Inability to undergo RT
- Life expectancy \<6 months
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.