Immune Response Evaluation in Oligorecurrent and Oligoprogressive Prostate Cancer Patients Treate… (NCT04624828) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Immune Response Evaluation in Oligorecurrent and Oligoprogressive Prostate Cancer Patients Treated With SBRT
Italy40 participantsStarted 2020-10-19
Plain-language 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
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
immune evaluation
Timeframe: from the baseline (before SBRT) to 7 days after the end of radiotherapy treatment