Clinical trial · Interventional
PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer
NCT04220983CI-TRIAL-00073673PRAGMAcompletedN/AResults postedClinicalTrials.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)
Patients with metastatic prostate cancer can undergo MRI-guided prostate Stereotactic body radiation therapy (SBRT) without significant adverse events, similar to what has been reported for patients with localized prostate cancer. We hypothesize that prostate SBRT will be well-tolerated in metastatic prostate cancer patients, with quality of life outcomes similar to what has been reported in non-metastatic prostate cancer patients.
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 |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR-Guided Prostate SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MR-Guided Prostate SBRT
- interventionNames
- Radiation: MR-Guided Prostate SBRT
Primary outcomes (1)
- measure
- Change in Number of Subjects With Adverse Events Will be Collected
- timeFrame
- baseline, 3-6months and at 9-12 months.
- description
- Treatment will be deemed safe if there is no more than 3 acute Grade 3 gasterointestinal/genitourinary events within the first 30 days after treatment completion. Adverse events can be unexpected or expected, related to treatment.
Secondary outcomes (2)
- measure
- Change in Quality of Life Questionnaires Will be Assessed.
- timeFrame
- baseline, 3-6months and at 9-12 months.
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-proven diagnosis of prostate adenocarcinoma * Age ≥ 18 * Must have biopsy-proven metastatic prostate cancer Exclusion Criteria: * History of prior pelvic radiation (external beam or brachytherapy) * Inability to undergo MRI * AUA score \>20 * For patients on systemic therapy, enrollment must be within six months of start of therapy unless exception is made by protocol PIs.
References
Publications (0)
Data not yet available
No reference posted for this study.