Early Magnetic Resonance Imaging Response of the Dominant Intraprostatic Lesion After Online Adap… (NCT06822491) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Early Magnetic Resonance Imaging Response of the Dominant Intraprostatic Lesion After Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer and Correlation With Prostate Specific Antigen Response
Switzerland28 participantsStarted 2024-08-20
Plain-language summary
The aim of this phase II study is to determine the early multiparametric magnetic resonance imaging response of the dominant intraprostatic lesion and correlate these findings with prostate specific antigen response in patients with intermediate to (very) high risk localized prostate cancer treated with online adaptive stereotactic radiotherapy without intraprostatic fiducial markers.
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:
* Patients with histologically confirmed localized prostate cancer who are planned for CT- or MRI-adaptive SBRT for prostate cancer;
* Presence of PIRADS ≥3 lesion(s) in a mpMRI correlating with Gleason ≥7 score at diagnosis;
* Intermediate to (very) high risk localized prostate cancer (≤ cT3b and cN0);
* ECOG performance status of 0-2;
* Age ≥ 18 years;
* PSMA PET ≤3 months is compulsory for high-risk prostate cancer (as part of clinical routine);
* Written informed consent.
* Willingness and ability to comply with schedule
Exclusion Criteria:
* Previous (≤10 years) local therapy of the prostate including transurethral resection of the prostate (TURP),
* Contraindication for MRI;
* Previous (≤10 years) radiotherapy in the pelvis;
* Lymph node metastases or distant metastases (i.e. no localized prostate cancer);
* Participation in a clinical trial which might influence the results of this project;
* Claustrophobic anxiety;
* Uncontrolled intercurrent illness;
* Relation to investigator (family or professional)
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
Multiparametric magnetic resonance imaging local control of the dominant intraprostatic lesion
Timeframe: 6 months after SBRT. In cases with image non-complete response at 6 months, 3 months later (in total 9 months after SBRT) an additional mpMRI will be performed.
2
Correlation of early prostate-specific antigen response with early multiparametric magnetic resonance imaging changes
Timeframe: 6 months after SBRT. In cases with image non-complete response at 6 months, 3 months later (in total 9 months after SBRT) an additional mpMRI will be performed.