Abstract
PURPOSE
To report acute toxicity and health-related quality of life (HRQoL) outcomes of a
phase II clinical trial of magnetic resonance imaging (MRI)-guided prostate high-dose-rate
brachytherapy (HDR-BT) combined with external beam radiotherapy.
METHODS AND MATERIALS
Patients with intermediate- and high-risk prostate cancer (PCa) were eligible. Treatment
consisted of a single 15 Gy MRI-guided HDR-BT followed by external beam radiotherapy
(37.5–46 Gy depending on their risk category). Dosimetry, toxicity and HRQoL outcomes
were collected prospectively at baseline, 1 and 3 months using Common Terminology
Criteria for Adverse Events Version 4.0 and the expanded PCa index composite, respectively.
General linear mixed modeling was conducted to assess the changes in expanded PCa
index composite domain scores over time. A minimally important difference was defined
as a deterioration of HRQoL scores at 3 months compared to baseline ≥ 0.5 standard
deviation. A p value ≤ 0.05 was considered statistically significant.
RESULTS
Sixty-one patients were included. Acute grade (G)2 urinary toxicity was observed in
18 (30%) patients while 1 (2%) patient had G3 toxicity, and none had G4 toxicity.
Two patients had an acute urinary retention. G2 gastrointestinal toxicity was reported
by 5 (8%) patients with no G3–4. Compared to baseline, urinary HRQoL scores significantly
declined at 1 month (p < 0.001) but recovered at 3 months (p > 0.05). Bowel (p < 0.001) and sexual (p < 0.001) domain scores showed a significant decline over the 3-month follow-up period.
At 3 months, 44%, 49% and 57% of patients reported a minimally important difference
respectively in the urinary bowel and sexual domains.
CONCLUSION
MRI-guided HDR-BT boost is a safe and well tolerated treatment of intermediate- and
high-risk PCa in the acute setting. A longer follow-up and a comparison to ultrasound-based
HDR-BT are needed to assess the potential benefit of MRI-guided prostate HDR-BT.
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Article info
Publication history
Published online: November 19, 2022
Accepted:
August 28,
2022
Received in revised form:
August 18,
2022
Received:
June 20,
2022
Footnotes
Disclosures: The authors report no proprietary or commercial interest in any product mentioned or concept discussed in this article. The authors report no proprietary or commercial interest in any product mentioned or concept discussed in this article.
Identification
Copyright
© 2022 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.
