BACKGROUND: This study was conducted to investigate a new short-course radiotherapy regimen for patients with metastatic hormone refractory prostate cancer (HRPC) presenting with a dominant debilitating symptom.
METHODS / DESIGN: This is an international, multi-center single arm prospective feasibility study that aims to include 34 patients with HRPC and a dominant debilitating symptom. The dominant symptomatic lesion will receive 4 × 5 Gy of high-precision radiotherapy, and the most aggressive part of the lesion 4 × 7 Gy using a simultaneous integrated boost technique. Based on advanced magnetic resonance imaging (MRI), an apparent diffusion coefficient (ADC) map will be calculated for the lesion using diffusion weighted imaging sequences. The dominant symptomatic lesion (GTV1) is drawn manually using the information from T2w-MRI and computed tomography scans. The most aggressive part of the dominant lesion (GTV2) is defined by using the ADC map. An auxiliary volume is created including only voxels in the GTV1 that presents with ADC values below 1200 × 10- 6 mm2/s. The most aggressive part is defined as voxels with an ADC value below the median ADC value. Primary endpoint is feasibility, i.e. proportion of patients who complete radiotherapy with =90% of the prescribed dose. Secondary endpoints include dominant symptom score, progression-free survival (freedom from symptoms), overall survival, acute toxicity, quality of life, change in ADC from baseline to end of treatment and 6 months following treatment.
DISCUSSION: If this new radiotherapy regimen proves to be feasible, a prospective randomized phase II/III dose escalation study will be designed in order to improve the outcomes of palliative radiotherapy of symptomatic metastatic HRPC.
STUDY STATUS: The study is ongoing and will be recruiting patients soon.
TRIAL REGISTRATION: clinicaltrials.gov NCT03658434 . Initially registered on 30th of July, 2018.
INTRODUCTION: To evaluate whether age is a predictor of pain response after radiotherapy for painful bone metastasis (BM).
METHODS: Between June 2010 and June 2014, 204 patients with BM undergoing palliative radiotherapy participated in a multicentre prospective study. Patients completed the Brief Pain Inventory (BPI) to rate the intensity pain (from 0 to 10) at baseline and 4 weeks after radiotherapy. To determine which variables predicted pain response and particularly whether age is a predictor, logistic regression analysis was used. Baseline variables considered were: age (=65/66–75/>75 years), sex, Eastern Cooperative Oncology Group performance status (0–1/=2), pretreatment pain score (=4/5–7/=8), radiotherapy (single/multiple fraction), primary tumour location, visceral metastases (yes/no), concomitant systemic chemotherapy and bisphosphonate use (yes/no).
RESULTS: Pain response was assessed in the 128 patients who completed BPI pretreatment and at 4 weeks after radiotherapy. According to univariate analysis, pain response was better in over 75-year-olds than younger patients: (OR, 3.2; 95% CI, 1.1–9.1; P = 0.031). Response was better in patients receiving multiple fractions rather than a single fraction of 8 Gy (OR, 2.8; 95% CI, 1.2–6.1; P = 0.01), and in patients with a pretreatment pain score =8 vs =7 (OR, 2.4; 95% CI, 1.1–5.0; P = 0.017). No other variables were significant. Multivariate analysis showed that treatment schedule (OR, 3.4; 95% CI 1.4–7.9; P = 0.004) and pre-radiotherapy pain score (OR, 2.8; 95% CI 1.3–6.3; P = 0.009) were the only independent predictors of pain response.
CONCLUSION: All patients with painful bone metastasis should be referred for palliative radiotherapy to relieve the pain regardless of age. Therefore, an older age should not be a reason to withhold palliative radiation treatment.