Health-related-quality-of-life and toxicity after single fraction 19 Gy high-dose-rate prostate brachytherapy: Phase II trial.

PURPOSE: To evaluate the safety, tolerance and impact on health-related-quality-of-life (HRQoL) of the high-dose-rate brachytherapy of 19 Gy (BRT-HDR-19 Gy) single fraction in prostate cancer. METHODS: From January 2014 to July 2016, 43 patients with low/intermediate risk were treated with BRT-HDR-19 Gy. The patients were monitored prospectively for toxicity and HRQoL. RESULTS: The median age, initial PSA and the International Prostate Symptom Score (IPSS) were 71 years (55-78), 7.0 ng/mL (4.2-17.8) and 5 (0-14) respectively. 44% were low-risk and 56% intermediate-risk. Median CTV-V100 (where Vn is the fractional volume of the organ that receives n% of the prescribed dose) was 96.5%, Urethral-Dmax 106% and rectum-2 cc (the dose to 2 cc of rectal wall) 53%. After a median follow-up of 20 months (4-26), acute grade-2 genitourinary (GU) toxicity occurred in 4 patients (9%) and none presented acute gastrointestinal (GI) toxicity. Similarly, four patients (9%) presented late GU grade-2 toxicity. No grade-3 toxicity occurred. In terms of HRQoL, there was a statistically significant decline in Expanded Prostate Cancer Index Composite (EPIC) urinary urgency/obstructive domain at month 3 (p = 0.047), and returned to baseline by month 6. Mean EPIC urinary incontinence, bowel, sexual and hormonal domains did not present significant post BRT-HDR-19 Gy changes. Patients rated their satisfaction at 6 months as "very-satisfied" (23%) or "extremely-satisfied" (77%). CONCLUSIONS: BRT-HDR-19 Gy demonstrates excellent results in terms of toxicity, tolerance, safety, patient satisfaction and HRQoL.

Dose escalation to dominant intraprostatic lesions with MRI-transrectal ultrasound fusion High-Dose-Rate prostate brachytherapy. Prospective phase II trial.

BACKGROUND AND PURPOSE: To demonstrate the feasibility, safety and effectiveness of dose escalation to intraprostatic lesions with MRI-transrectal ultrasound fusion High-Dose-Rate (HDR) brachytherapy. MATERIALS AND METHODS: 15 patients with intermediate-high risk prostate cancer and visible dominant intra-prostatic nodule on mpMRI have been treated. The treatment consisted of combined MRI-TRUS fusion HDR-brachytherapy (1 fraction of 1500cGy) and hypofractionated external beam (3750cGy in 15 fractions). A dose of 1875Gy was delivered to at least 98% of the DIL volume. RESULTS: Median prostate volume was 23.8cc; median number of needles was 16 (13-18). Dose escalation to DIL was feasible in 14/15 patients (93%) without violating dosimetric constraints and 1 patient presented a minimal deviation of dosimetric restrictions. With a median follow-up of 18months (17-24), none of the patients developed acute urinary retention or grade ⩾3 toxicity. In addition to standard PSA follow-up, response has been assessed by mpMRI at 12months. All patients presented adequate morphological responses on anatomical and functional sequences. CONCLUSIONS: HDR brachytherapy using MRI-transrectal ultrasound fusion for image guidance is a suitable technique for partial prostate dose escalation. Tolerance and toxicity profiles are excellent and results are encouraging in terms of biochemical, morphological and functional response.

Incidence of pain flare following palliative radiotherapy for symptomatic bone metastases: multicenter prospective observational study.

BACKGROUND: Palliative radiotherapy (RT) is an effective treatment for symptomatic bone metastases. Pain flare, a transient worsening of the bone pain after RT, has been described in previous reports with different incidence rates. The aim of the study was to prospectively evaluate the incidence of pain flare following RT for painful bone metastases and evaluate its effects on pain control and functionality of the patients. METHODS: Between June 2010 and June 2014, 204 patients were enrolled in this study and 135 patients with complete data were evaluable. Pain flare was defined as a 2- point increase in worst pain score as compared with baseline with no decrease in analgesic intake or a 25% increase in analgesic intake as compared with baseline with no decrease in worst pain score. All pain medications and worst pain scores were collected before, daily during, and for 10 days after RT. The Brief Pain Inventory (BPI) was filled out on the pretreatment and at the 4 weeks follow-up visit. RESULTS: There were 90 men (66.7%) and 45 women (33.3%). Mean age was 66 years (SD 9.8). The most common primary cancer site was lung in 42 patients (31.1%), followed by prostate in 27 patients (20.0%). Forty-two patients (31.1%) patients received a single fraction of 8 Gy and 83 (61.5%) received 20 Gy in five fractions. The overall pain flare incidence across all centers was 51/135 (37.7%). The majority of pain flares occurred on days 1-5 (88.2%). The mean duration of the pain flare was 3 days (SD: 3). There were no significant relationships between the occurrence of pain flare and collected variables. All BPI items measured four weeks after end of RT showed significant improvement as compared with pretreatment scores (p < 0.001). No significant differences in BPI time trends were found between patients with and without flare pain. CONCLUSION: Pain flare is a common event, occurring in nearly 40% of the patients that receive palliative RT for symptomatic bone metastases. This phenomenon is not a predictor for pain response.