ABSTRACT
Background: The role of cytoreductive local radiotherapy (RT) in metastatic prostate cancer (mPCa) has recently been established. This study aimed to evaluate the biochemical outcome of local RT in mPCa. Methods: This randomised controlled phase III study was conducted at the Clinical Oncology Department, Suez Canal University Hospital. Eligible participants were de-novo or metachronous mPCa patients with Eastern Cooperative Oncology Group performance status of 0-2. Participants were randomised to receive either cytoreductive prostate-directed RT in addition to standard care or standard care alone. The conventional radiation schedule of 70 Gy/35 fractions or the hypofractionated schedule of 55 Gy/20 fractions were delivered. The primary endpoint was biochemical progression-free survival (BPFS), and the secondary endpoint was overall survival (OS). Survival and post-hoc analyses were performed using Cox regression and the Kaplan-Meier method with the log-rank test. Results: Between 23 November 2020 and 21 2022, 70 patients were enrolled in this study. Of them, 34 patients were assigned to the prostate RT group, and 29 patients were assigned to the control group. At a median follow-up of 12 months, the median BPFS has not been reached for the prostate RT group compared to 4.067 months for the control group (HR: 0.147, p < 0.001). Subgroup analysis showed that the median BPFS was statistically significantly correlated with low-volume (95% CI, 0.004 to 0.262, p = 0·001) and hormonal-sensitive metastatic disease (95% CI, 0.010 to 0.192, p < 0·001). The median OS was 16.33 months for the prostate-RT group compared to 11.33 months for the control group (HR: 0.313, p = 0.003). Conclusion: Prostate-directed RT improved BPFS and OS in mPCa patients, particularly in those with low volume and hormonal-sensitive disease. Trial Registration: This trial is registered on (27/4/2023), retrospectively registered with pactr.samrc.ac.za, PACTR202305854600529, URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25510.
ABSTRACT
BACKGROUND: The impact of prostate radiotherapy on patient-reported health-related quality of life (HRQoL) significantly influences the outcomes of metastatic prostate cancer. We measured and compared HRQoL of metastatic prostate cancer patients who received cytoreductive prostate radiotherapy. METHODS: Between November 23, 2020, and November 21, 2022, we recruited 70 metastatic prostate cancer patients at the Department of Clinical Oncology at Suez Canal University Hospital. Patients were eligible if they had synchronous and metachronous histopathological confirmed metastatic adenocarcinoma and an Eastern Cooperative Oncology Group performance status ≤ 2. Random allocation was performed for either definitive local radiotherapy concurrent with the standard androgen deprivation therapy (ADT) or to the standard ADT alone. Definitive radiotherapy was delivered conventionally (70 Gy/35 fractions) or through the hypofractionated regimen (55 Gy/20 fractions). Patients completed the comprehensive European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-PR25) at baseline, then at three-month intervals for one year. The primary endpoint was patient-reported HRQoL, with secondary endpoints including toxicity and radiographic progression-free survival (rPFS). Mean HRQoL scores between groups were compared using the independent samples t-test. RESULTS: We observed clinically significant improvements in urinary and bowel functions between baseline, 3-month, 6-month, and 12-month intervals after receiving definitive prostate radiotherapy. Patients in the radiotherapy group had significantly lower urinary symptoms scores than the control group. However, sexual activity and functioning showed significant deterioration. CONCLUSION: Cytoreductive prostate radiotherapy in metastatic prostate cancer patients significantly improved urinary functioning, preserved bowel functioning but was associated with worsening of sexual functioning. TRIAL REGISTRATION: This trial was registered on (27/04/2023) with pactr.samrc.ac.za, PACTR202305854600529, URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25510 .
