Evaluating MRI response in prostate cancer after targeted radiotherapy
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 (PRODART)
This study is testing how well targeted radiotherapy works for men with localized prostate cancer by looking at changes in their MRI scans and PSA levels over several months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT06822491 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the early response of the dominant intraprostatic lesion in patients with localized prostate cancer undergoing online adaptive stereotactic body radiotherapy (SBRT). It will correlate changes observed through multiparametric magnetic resonance imaging (mpMRI) with prostate-specific antigen (PSA) levels over a period of 6 to 9 months post-treatment. The study focuses on patients with intermediate to high-risk localized prostate cancer and seeks to determine the effectiveness of SBRT in achieving local control of the disease. A total of 28 patients will be enrolled to evaluate the primary outcome of imaging response.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with histologically confirmed localized prostate cancer and a dominant intraprostatic lesion identified on mpMRI.
Not a fit: Patients with previous local therapy for prostate cancer or those with metastases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the monitoring and treatment strategies for localized prostate cancer, potentially leading to better patient outcomes.
How similar studies have performed: While stereotactic body radiotherapy is an established treatment, the specific correlation of mpMRI changes with PSA response in this context is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Zurich
- University Hospital Zurich — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Matthias Guckenberger, Prof. Dr. med. — University of Zurich
- Study coordinator: Tiuri Kroese, MD, PhD
- Email: tiuri.kroese@usz.ch
- Phone: +41 43 253 81 96
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.