N/A
Completed N=30
MRI-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost for Prostate Cancer
Source: ClinicalTrials.gov NCT03664193 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Jan 2021
Primary outcomePrimary: Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB). — 9; 14; 2; 5 Participants
Summary
Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB). |
9; 14; 2; 5 | — |
| PRIMARY Number of Participants Who Received Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost (SIB) Without Greater Than Grade 3 GU/GI Toxicities. |
30 | — |
| SECONDARY Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. |
87.9; 93.1; 58.5; 90; 93.1; 94.2 | — |
| SECONDARY American Urological Association (AUA) Questionnaire Will be Assessed. |
6; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Biopsy-proven diagnosis of prostate adenocarcinoma
- NCCN defined low-, intermediate- and high-risk prostate cancer
- Age ≥ 18
- Patient must have prostate MRI with a PIRADS 3-5 lesion or PSMA positron emission tomography (PET) with an avid intraprostatic lesion
Exclusion Criteria
- History of prior pelvic radiation (external beam or brachytherapy)
- Inability to undergo MRI
- Patients with metastatic disease (other than pelvic lymph nodes) are ineligible for this study
- American Urological Association (AUA) score >17 - AUA score >17
Data sourced from ClinicalTrials.gov (NCT03664193). 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.