Clinical trial · Observational
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
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localized Prostate Adenocarcinoma | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
| Magnetic Resonance Imaging | — | UNRESOLVED | — |
| Multiparametric MRI | — | UNRESOLVED | — |
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stereotactic Body Radiotherapy | — | UNRESOLVED | — |
| Stereotactic Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- 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.
- description
- To study multiparametric magnetic resonance imaging (mpMRI) local control of Prostate Imaging Reporting and Data System (PIRADS) ≥3 lesion(s) after SBRT. An image complete response is defined as disappearance of all morphological and functional PIRADS ≥3 lesion(s) correlating with Gleason ≥7a pathology in mpMRI.
- measure
- 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.
- description
- To correlate early prostate-specific antigen response with early multiparametric magnetic resonance imaging changes of the PIRADS ≥3 lesion(s) correlating with Gleason ≥7a pathology
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available