Trial reportThe Prostate2025
Primary Analysis of (NCT03380806) a Phase II Randomized Trial of Stereotactic Body Radiotherapy Boost Versus Conventional Fractionation External Beam Radiotherapy Boost in Unfavorable-Intermediate and High-Risk Prostate Cancer.
Trial report in The Prostate, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03380806 (A Randomized Phase II Trial Investigating Stereotactic Body RadioTherapy), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Phase II Trial Investigating Stereotactic Body RadioTherapy (SBRT) for Prostate Boost Irradiation in the Treatment of High Risk Prostate Cancer (PrCa)
Who cites it
1 citing paper in PubMed.
- Interobserver variability in dominant intraprostatic lesion delineation usingReports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
Abstract
backgroundStandard treatment for unfavorable-intermediate and high-risk prostate cancer involves androgen deprivation therapy (ADT) in combination with pelvic conventional fractionation (CF) external beam radiotherapy (EBRT) and a CF-EBRT or brachytherapy boost to the prostate. This trial compared CF-EBRT boost with stereotactic body radiotherapy (SBRT) boost after pelvic CF-EBRT.
methodsPatients were randomized to receive a boost using either CF-EBRT (32-34 Gy in 15-17 fractions) or SBRT (19.5-21 Gy in three weekly fractions) following pelvic CF-EBRT (45-46 Gy in 23-25 fractions). The primary objective was to assess early (3-month post-radiotherapy) gastrointestinal (GI) and genitourinary (GU) quality of life (QoL), using the expanded prostate index composite (EPIC) score. Secondary objectives included long-term QoL, International Prostate Symptom Score (IPSS) changes, toxicity assessments, and long-term disease control outcomes. Linear regression and Fisher's exact test were used for analysis.
resultsOf the 100 patients randomized, 53 received CF-EBRT, and 47 received SBRT. After a mean follow-up of 18.5 months, no significant differences were observed in EPIC score changes between CF-EBRT and SBRT at 3 months posttreatment for urinary (11.5 vs. 8.6, p = 0.23), bowel (5.2 vs. 6.4, p = 0.57), and overall QoL (8.3 vs. 7.5, p = 0.61). IPSS scores were similar (p = 0.11), and CTCAE v.5.0 toxicity rates were comparable, with an odds ratio of 0.90 (p > 0.99). Biochemical failure rates were under 5% for both groups.
conclusionsThis is the first randomized trial to report QoL outcomes after SBRT boost radiotherapy in patients with unfavorable-intermediate and high-risk prostate cancer. SBRT boost after pelvic CF-EBRT is well-tolerated and demonstrates comparable outcomes in QoL and toxicity to the CF-EBRT boost. Further follow-up is needed to assess the long-term effects on QoL, toxicity, and disease control.
trial registrationClinicalTrials.gov identifier: NCT03380806.
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