SPARKLE: a new spark in treating oligorecurrent prostate cancer: adding systemic treatment to stereotactic body radiotherapy or metastasectomy: key to long-lasting event-free survival?

BACKGROUND: Metastasis-directed therapy (MDT) significantly delays the initiation of palliative androgen deprivation therapy (pADT) in patients with oligorecurrent prostate cancer (PCa) with a positive impact on patient's quality of life. However, it remains unclear whether the addition of ADT improves polymetastatic free survival (PMFS) and metastatic castration refractory PCa-free survival (mCRPC-FS) and how long concomitant hormone therapy should be given. A significant overall survival (OS) benefit was shown when an androgen receptor targeted agent (ARTA) was added to pADT in patients with metastatic hormone sensitive PCa (HSPC). However, whether the addition of and ARTA to MDT in the treatment of oligorecurrent PCa results in better PMFS and mCRPC-FS has not been proven yet. METHODS & DESIGN: Patients diagnosed with oligorecurrent HSPC (defined as a maximum of 5 extracranial metastases on PSMA PET-CT) will be randomized in a 1:1:1 allocation ratio between arm A: MDT alone, arm B: MDT with 1 month ADT, or arm C: MDT with 6 months ADT together with ARTA (enzalutamide 4 × 40 mg daily) for 6 months. Patients will be stratified by PSA doubling time (≤ 3 vs. > 3 months), number of metastases (1 vs. > 1) and initial localization of metastases (M1a vs. M1b and/or M1c). The primary endpoint is PMFS, and the secondary endpoints include mCRPC-FS, biochemical relapse-free survival (bRFS), clinical progression free survival (cPFS), cancer specific survival (CSS), overall survival (OS), quality of life (QOL) and toxicity. DISCUSSION: This is the first prospective multicentre randomized phase III trial that investigates whether the addition of short-term ADT during 1 month or short-term ADT during 6 months together with an ARTA to MDT significantly prolongs PMFS and/or mCRPC-FS. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05352178, registered April 28, 2022.

Correlations between age, Charlson score and outcome in clinical unilateral T3a prostate cancer / 亚洲男科学杂志(英文版)

According to the European Association of Urology (EAU) guidelines, a life expectancy of > 10 years is considered an important factor in the treatment of prostate cancer. The Charlson score is used to predict mortality based on comorbidities. The purpose of this study was to investigate the relationship between age, Charlson score and outcome in patients with cT3a prostate cancer. Between 1987 and 2004, 200 patients, who were with clinical T3a prostate cancer and who underwent radical prostatectomy (RP), were previously detected by digital rectal examination (DRE). Patients were categorized into two age groups (< 65 and >or= 65 years old). Patients were also divided into two groups according to Charlson score ( = 0 and >or= 1). Both age and Charlson score were analyzed regarding their predictive power of patients' outcomes. The mean follow-up period was 70.6 months, and the mean age of patients was 63.3 years. In all, 106 patients were < 65 years old and 94 patients were >or= 65 years old. Age was a significant predictor of overall survival (OS). A Charlson score of 0 was found in 110 patients, and of >or= 1 in 90 patients. Charlson score was not a significant predictor of biochemical progression-free survival (BPFS), clinical progression-free survival (CPFS) or OS. Cox multivariate analysis showed that margin status was a significant independent factor in BPFS, and cancer volume was a significant independent factor in CPFS. Charlson score does not influence the outcome in patients with clinical locally advanced prostate cancer. Age may influence OS. RP can be performed in motivated healthy older patients. However, the patients need to be counseled regarding possible surgery-related side effects, such as urinary incontinence and erectile dysfunction, which are age- and comorbidity-dependent.