Clinical trial · Interventional
Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer
NCT05328505CI-TRIAL-00106293MIDAS-ProstaterecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a Phase II prospective single-arm trial that is recruiting 80 participants from patients that have biochemical failure after radical prostatectomy with local or regional recurrence proven by PSMA PET. Participants of this study will receive molecular imaging informed radiation dose escalation to site of recurrent disease and de-escalation to uninvolved areas. Participants will be follow-up as per standard of care up to 5 years post-treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Image-guided Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Molecular Imaging Informed Radiation Dose Escalation and De-escalation
- description
- Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas.
- interventionNames
- Radiation: Image-guided Radiotherapy
Primary outcomes (1)
- measure
- Grade ≥2 Toxicity for GU
- timeFrame
- Baseline to 5-year follow-up
- description
- Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Secondary outcomes (2)
- measure
- Biochemical Failure Free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men older than 18 years old. * Histologically proven initial diagnosis of adenocarcinoma prostate cancer. * Previous radical prostatectomy. * Biochemical relapse with local or regional recurrence proven on PSMA PET. * Five or less positive nodes on the PSMA PET. * ECOG 0-1 Exclusion Criteria: * Presence of para-aortic lymph nodes or distant metastasis. * Chronic pelvic inflammatory disease. * Contraindication for radiation treatment. * Previous radiation treatment within the pelvis
References
Publications (0)
Data not yet available
No reference posted for this study.