Acute toxicity and health-related quality of life outcomes of localized prostate cancer patients treated with magnetic resonance imaging-guided high-dose-rate brachytherapy: A prospective phase II trial.

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.

Dose to the bladder neck in MRI-guided high-dose-rate prostate brachytherapy: Impact on acute urinary toxicity and health-related quality of life.

PURPOSE: To assess the impact of the dose to the bladder neck (BN) on acute urinary toxicity (AUT) and health-related quality of life (uHRQoL) in patients with prostate cancer treated with MRI-guided high-dose-rate brachytherapy combined to external beam radiotherapy. METHODS AND MATERIALS: Sixty-one patients were treated with a single 15-Gy MRI-guided high-dose-rate brachytherapy followed by external beam radiotherapy as part of a prospective Phase II trial. The BN was delineated in retrospect on T2-weighted images. AUT and uHRQoL data were collected prospectively using Common Terminology Criteria for Adverse Events version 4.0 and the expanded prostate index composite. A minimally important difference (MID) was defined as a deterioration of uHRQoL scores at 3 months ≥ 0.5 standard deviation of baseline score. Linear and logistic regression models were used. RESULTS: The median BN volume was 0.6 cc. The median BN and urethral maximum dose (BNDmax and UDmax) were 22 Gy and 20 Gy, respectively. BNDmax was significantly associated with UDmax (p = 0.03). AUT Grade 2 + was observed in 32% of patients. Among those, 4 patients had an acute urinary retention (AUR). No Grade 4 + toxicity was reported. At 3 months, 47% of patients reported an MID in urinary uHRQoL. None of the dosimetric parameters including BNDmax was associated with acute Grade 2 + urinary toxicity or MID. However, 3 of 4 patients with AUR had a BNDmax in the highest quartile; >175% of prescription dose. CONCLUSIONS: Although a high BN dose was observed in patients who had an AUR, the predictive value of this parameter is yet to be determined in a larger cohort.