N/A
N=22
PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer
Metastatic Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04220983 ↗Enrolled (actual)
22
Serious AEs
4.6%
Results posted
Feb 2024
Primary outcome: Primary: Change in Number of Subjects With Adverse Events Will be Collected — 22; 18; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MR-Guided Prostate SBRT (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Feb 2023
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 | — |
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.
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.