Combined MRI-TRUS fusion targeted and systematic biopsy versus systematic biopsy alone for the detection of prostate cancer: protocol for a prospective single-centre trial.

INTRODUCTION: The classic way of diagnosing prostate cancer (PCa) is by conducting the 12-core systematic biopsy (SB). However, it has a low detection rate for clinically significant PCa (csPCa) and can lead to the detection of clinically insignificant PCa (cisPCa). Although MRI-transrectal ultrasound (MRI-TRUS) fusion targeted biopsy (TB) can effectively improve the detection rate of csPCa, it may still miss some cases. Therefore, we propose using a combination of TB and SB methods to enhance the detection rate of csPCa while minimising the detection rate of cisPCa. METHODS AND ANALYSIS: This study is a prospective, single-centre investigation that aims to assess and compare the detection rate of csPCa using MRI-TRUS fusion TB combined with SB versus TRUS 12-core SB alone. Biopsy-naïve men with suspected PCa will be subjected to multiparametric MRI. Patients with Prostate Imaging Reporting and Data System (V.2.1) score ≥3 will be enrolled in the TB-SB combination group. The sample size is established as 660 participants, considering a 10% drop-out rate. The primary outcome is the detection rate of csPCa in men without prior biopsy using MRI-TRUS fusion TB combined with the standard TRUS-guided 12-core SB method. CsPCa will be defined as International Society of Urological Pathology Grade ≥2. ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee at the Shanghai Tenth People's Hospital, an affiliated hospital of Tongji University School of Medicine. The research results will be published in a peer-reviewed international journal. TRIAL REGISTRATION NUMBER: ChiCTR2000036089.

Olaparib Combined with Abiraterone versus Olaparib Monotherapy for Patients with Metastatic Castration-resistant Prostate Cancer Progressing after Abiraterone and Harboring DNA Damage Repair Deficiency: A Multicenter Real-world Study.

BACKGROUND AND OBJECTIVE: Olaparib + abiraterone has a combined antitumor effect in metastatic castration-resistant prostate cancer (mCRPC), but the efficacy of this combination in patients with DNA damage repair (DDR)-deficient mCRPC progressing after abiraterone is unknown. Our aim was to compare the efficacy of olaparib + abiraterone versus olaparib monotherapy for patients with DDR-deficient mCRPC progressing after abiraterone. METHODS: The study included 86 consecutive patients with DDR-deficient mCRPC progressing after abiraterone: 34 received olaparib + abiraterone, and 52 received olaparib monotherapy. DDR-deficient status was defined as the presence of a DDR gene with a pathogenic or likely pathogenic variant (DDR-PV), or with a variant of unknown significance (DDR-VUS). We assessed progression-free survival (PFS) and overall survival (OS) using the Kaplan-Meier method. Potential factors influencing PFS and OS were compared between the treatment arms using Cox proportional-hazards models. The prostate-specific antigen (PSA) response, the treatment effect across subgroups, and adverse events (AEs) were also evaluated. KEY FINDINGS AND LIMITATIONS: Median follow-up was 9 mo. In the overall cohort, median PFS and OS were significantly longer in the combination arm than in the monotherapy arm (PFS: 6.0 vs 3.0 mo; hazard ratio [HR] 0.41, 95% confidence interval [CI] 0.25-0.67; p < 0.01; OS: 25.0 vs 12.0 mo; HR 0.30, 95% CI 0.14-0.67; p < 0.01). PSA responses were significantly higher following combination therapy versus monotherapy. Combination therapy had significantly better efficacy in the DDR-PV and DDR-VUS subgroups, and was an independent predictor of better PFS and OS. AE rates were acceptable. The retrospective nature, small sample size, and short follow-up are limitations. CONCLUSIONS: Olaparib + abiraterone resulted in better PFS and OS than olaparib alone for patients with DDR-deficient mCRPC progressing after abiraterone. These results need to be confirmed by a large-scale prospective randomized controlled trial. PATIENT SUMMARY: Our study shows that the drug combination of olaparib plus abiraterone improved survival over olaparib alone for patients who have mutations in genes affecting DNA repair and metastatic prostate cancer resistant to hormone therapy. The results provide evidence of a synergistic effect of the two drugs in these patients.

Postoperative chemotherapy significantly improves survival of elderly patients with stage IB-II non-small cell lung cancer: A population-based study.

BACKGROUND: There is scant evidence-based information about survival benefits of postoperative chemotherapy in elderly patients with early-stage non-small cell lung cancer (NSCLC). The purpose of this study is to compare the overall survival (OS) and cancer-specific survival (CSS) rates of surgery alone versus postoperative chemotherapy in patients aged ≥70 years with stage I-II NSCLC. METHODS: Elderly patients aged ≥70 years diagnosed with stage I-II NSCLC were selected from the Surveillance, Epidemiology, and End Results (SEER) database from January 1, 2010 to December 31, 2015. OS and CSS were compared between the two groups utilizing overlap weighting analysis, inverse probability of treatment weight (IPTW), and propensity score matching (PSM). RESULTS: Of the 7193 included patients with stage I-II NSCLC who are more than 70 years old, 681 patients (9.5%) received postoperative chemotherapy and 6512 patients (90.5%) received surgery-alone. Median OS was 77 months in postoperative chemotherapy group versus 79 months in surgery-alone group (p = 0.89). The result of IPTW analysis showed the similar results. The probability of patients choosing chemotherapy increased with the AJCC stage and Grade increasing (p < 0.001) and decreased with the growth of age (p < 0.001). The results of subgroup analysis showed that the survival rate of stage IA patients decreased significantly after postoperative chemotherapy (p < 0.01) while the survival rate of stage IB-II patients increased significantly (p < 0.01). At the same time, we found that patients in the postoperative chemotherapy group tended to have better OS than those in the surgery-alone group with the grade and tumor size increasing. CONCLUSION: The results of this study indicated that postoperative chemotherapy could significantly improve the survival of stage IB-II NSCLC patients aged ≥70 years, and decrease the survival of stage IA patients.