N/A
Completed N=22
PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer
Source: ClinicalTrials.gov NCT04220983 ↗Enrolled (actual)
22
Serious AEs
4.6%
Results posted
Feb 2024
Primary outcomePrimary: Change in Number of Subjects With Adverse Events Will be Collected — 22; 18; 17 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Subjects With Adverse Events Will be Collected |
22; 18; 17 | — |
| SECONDARY Change in Quality of Life Questionnaires Will be Assessed. |
80.6; 83.4; 96.8; 8.6; 74.1; 84.75 | — |
| SECONDARY Change in The International Prostate Symptom Score (I-PSS) Will be Assessed. |
10.7; 9; 12.2 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04220983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.