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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
Author(s) -
Gouveia Andre,
Mesci Aruz,
Isfahanian Naghmeh,
Dayes Ian,
Quan Kimmen,
Goldberg Mira,
Schnarr Kara Lynne,
Lukka Himu,
Cuthbert David,
Hallock Abhiram,
Douvi Georgia,
Wright Jim,
Swaminath Anand,
Chow Tom,
Diamond Kevin,
Hajdok George,
Maharaj Lindsay,
Ewusie Joycelyne,
Tsakiridis Theodoros
Publication year - 2025
Publication title -
the prostate
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.295
H-Index - 123
eISSN - 1097-0045
pISSN - 0270-4137
DOI - 10.1002/pros.24905
Subject(s) - medicine , external beam radiotherapy , prostate cancer , brachytherapy , urology , dose fractionation , radiation therapy , androgen deprivation therapy , prostate , clinical endpoint , randomized controlled trial , oncology , cancer
ABSTRACT Background Standard 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. Methods Patients 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. Results Of 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. Conclusions This 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 Registration: ClinicalTrials.gov identifier: NCT03380806.