bluuebunny/crossref_metadata_2025_split huggingface dataset:
[68Ga]Ga-PSMA-11 PET baseline imaging as a prognostic tool for clinical outcomes to [177Lu]Lu-PSMA-617 in patients with mCRPC: A VISION substudy.
Authors: Kuo Phillip , Hesterman Jacob , Rahbar Kambiz , Kendi Ayse T. , Wei Xiao X. , Fang Bruno , Adra Nabil , Armstrong Andrew J. , Garje Rohan , Michalski Jeff M. , Ghebremariam Samson , Brackman Marcia , Wong Connie , Benson Taylor , Vogelzang Nicholas J. 
Published: June 2022

5002 Background: In the phase 3 VISION study, gallium (68Ga) gozetotide (68Ga-PSMA-11) PET/CT imaging was used to determine eligibility for lutetium (177Lu) vipivotide tetraxetan (177Lu-PSMA-617). Given that 177Lu-PSMA-617 targets PSMA, we assessed the association between quantitative PSMA imaging parameters and treatment outcomes. Methods: In VISION, adults with mCRPC with ≥ 1 PSMA-positive (+) and no PSMA-negative lesions meeting the exclusion criteria were enrolled. In this sub-study, the association between imaging data from pre-enrollment 68Ga-PSMA-11 PET/CT scans of pts in the 177Lu-PSMA-617 group and clinical outcomes was assessed. Imaging data meeting quality requirements were analyzed for 548/551 pts. PSMA expression was quantified by 5 PET parameters: PSMA+ lesions by region, mean standardized uptake value (SUVmean), maximum SUV (SUVmax), PSMA+ tumor volume, and tumor load (PSMA+ tumor volume × SUVmean). Parameters were extracted from the whole body and 4 regions. Association between PET parameters and radiographic progression-free survival (rPFS; primary objective), overall survival (OS), objective response rate (ORR), and prostate–specific antigen 50 (PSA50) response was assessed. Results: Most pts (92.7%) had PSMA uptake in bone. In both the whole-body and regional analyses, statistically significant associations of PSMA PET parameters to clinical outcomes were observed (whole-body data shown in Table). Higher whole-body SUVmean was associated with improved clinical outcomes; pts in the highest quartile (SUVmean: rPFS, ≥ 10.2; OS, ≥ 9.9) had a median rPFS and OS of 14.1 and 21.4 months, vs 5.8 and 14.5 months for those in the lowest quartile (< 6.0; < 5.7), respectively. Absence of PSMA+ lesions in bone, liver, and lymph node, and lower PSMA+ tumor load, were indicators of good prognosis. Conclusions: Higher SUVmean is strongly associated with improved outcomes with 177Lu-PSMA-617; clinical efficacy for different SUV levels vs the SoC arm is being assessed. Data support use of 68Ga-PSMA-11 PET/CT scan to identify pts who will benefit from PSMA-targeted radioligand therapy.[Table: see text]
Prognostic significance of raised serum tumor markers (STM) after 2 cycles of chemotherapy in men with intermediate- and poor-risk non-seminomatous testicular germ cell tumors (NSGCT) treated at a single-centre in India.
Authors: VARSHNEY ANKUR NANDAN , Raj Abhishek , Sahoo Ranjit Kumar , KP Haresh , Singh Prabhjot , Shamim Shamim Ahmed , Seth Amlesh , Ray M D INDIA INSTITUTE OF MEDICAL , Kaushal Seema , Das Chandan Krushna , Batra Atul 
Published: June 2022

5036 Background: Testicular GCT is a rare malignancy, with excellent outcomes. However, approximately one-fourth of intermediate risk and half of the patients with poor risk disease succumb to recurrent GCT. We looked at the prognostic significance of raised serum tumor markers after 2 cycles of chemotherapy in patients with poor risk GCT. Methods: This is a chart-review based retrospective analysis of patients with intermediate and poor risk NSGCT diagnosed and treated at a tertiary care centre in New Delhi, India from 2015-2021. Risk categories were defined as per the International Germ Cell Cancer Collaborative Group. Multivariable Cox regression models were constructed to analyse the prognostic impact of normal STM at the end of second cycle of chemotherapy on overall survival (OS) and relapse free survival (RFS), while adjusted for measured confounders. Results: A total of 312 patients were identified with testicular NSGCT, of whom 109 were intermediate (n = 48, 44%) and poor risk (n = 61, 56%). The median age at diagnosis was 27 (interquartile range, 21-34) years. ECOG PS of patients was 0-1 in 51% and 2-4 in 49%, and poor risk patients were more likely to have a poor ECOG PS at diagnosis (70% vs 30%, P < 0.001). First-line chemotherapy was BEP in 86% patients and VIP in the remaining 14%, and surgery for residual disease was performed in 22%. Overall, 35% patients had normal STM after 2 cycles of chemotherapy, and patients with intermediate risk were likely to achieve normal STM at this time-point (50% vs 23%). At a median follow-up of 62 months, the 5-year RFS rate was 62% (poor risk 52% and intermediate risk 78%), and OS rate was 68% (58% and 80%, respectively). Men with normal STM after 2 cycles chemotherapy had a better RFS (hazard ratio [HR], 0.70; 95% confidence interval 0.48-0.81; P < 0.001) and OS (HR,0.82; 95% CI 0.61-0.99; P = 0.04). After adjusting for risk category, and ECOG PS in a multivariable Cox regression model, patients with normal STM at the end of 2 cycles of chemo continued to have better outcomes (adjusted HR for RFS, 0.78; 95% CI, 0.77-0.89; P = 0.03, and adjusted HR for OS, 0.92; 95% CI,0.81-0.99; P = 0.05). Intermediate risk NSGCT and good ECOG PS also predicted better RFS and OS. Conclusions: Patients with NSGCT whose STMs do not normalize after 2 cycles of chemotherapy have worse RFS and OS compared to those with normal STM at this time-point. Further clinical trials will be needed to study the role of escalation or switch of chemotherapy in this subset of population.
Candidate surrogate endpoints in advanced prostate cancer: Aggregate meta-analysis of 143 randomized trials.
Authors: Gharzai Laila A , Jiang Ralph , Jaworski Elizabeth , Morales Krystal A , Dess Robert Timothy , Jackson William C. , Hartman Holly , Mehra Rohit , Kishan Amar Upadhyaya , Solanki Abhishek A , Schaeffer Edward M. , Feng Felix Y , Zaorsky Nicholas George , Berlin Alejandro , Ponsky Lee Evan , Shoag Jonathan Evan , Sun Yilun , Schipper Matthew J. , Garcia Jorge A. , Spratt Daniel Eidelberg 
Published: June 2022

5039 Background: The Intermediate Clinical Endpoints (ICEs) in Cancer of the Prostate (ICECaP) working group identified metastasis-free survival as a valid surrogate endpoint for overall survival (OS) for patients with localized prostate cancer. No comparably validated surrogate endpoints for OS exist in advanced prostate cancer. Methods: In this meta-analysis, PubMed was searched for trials in advanced prostate cancer, defined as node positive (N1M0), metastatic castration-sensitive (mCSPC), non-metastatic (M0CRPC), or metastatic castration-resistant prostate cancer (mCRPC). Eligible randomized trials were required to report OS and ≥1 intermediate clinical endpoint (ICE). ICEs included biochemical-failure (BF), clinical failure (CF), BF-free survival (BFS), progression-free survival (PFS), radiographic PFS (radiographic +/- other study defined endpoints). Candidacy for surrogacy was assessed using the second condition of the meta-analytic approach, correlation of the treatment effect of the ICE and OS, using R2 weighted by the inverse variance of the log ICE hazard ratio and defined as an R2 > 0.70. Results: A total of 143 randomized trials (n = 75,601 patients) were included. No candidate endpoints met criteria for surrogacy; R2 BF (n = 28,922) 0.42 (95%CI 0.18-0.64), BFS (n = 25,741) 0.57 (95%CI 0.37-0.73), CF (n = 22,616) 0.31 (95%CI 0.0075-0.56), PFS (n = 52,639) 0.50 (95%CI 0.35-0.63), and radiographic PFS (n = 52,548) 0.50 (95%CI 0.35-0.63). Within preplanned subgroups by castration sensitive or resistant disease, or by treatment type, neither BFS nor PFS met criteria for surrogacy. When assessing radiographically-defined progression (exclusive or with clinical progression), PFS for the overall group and by castration status did not meet criteria for surrogacy. Sensitivity analyses demonstrated that candidacy for surrogacy of all endpoints tested did not change over time. Conclusions: Our aggregate screening method for surrogate endpoints in advanced prostate cancer demonstrated commonly used clinical endpoints are not valid surrogate endpoints for OS, and further composite endpoint construction is necessary.
Safety and survival outcomes in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with lutetium-177–prostate-specific membrane antigen (177Lu-PSMA) after radium-223 (223Ra): Interim analysis of the RALU study.
Authors: Rahbar Kambiz , Essler Markus , Eiber Matthias , la Fougère Christian , Prasad Vikas , Fendler Wolfgang P. , Rassek Philipp , Hasa Ergela , Dittmann Helmut , Bundschuh Ralph A. , Pabst Kim M. , Kurtinecz Milena , Sandstrom Per , Verholen Frank , Sartor A. Oliver 
Published: June 2022

5040 Background: 223Ra and 177Lu-PSMA both prolong overall survival (OS) in different mCRPC settings. Previous data from the observational REASSURE (Sartor O, et al. 2021) and WARMTH (Ahmadzadehfar H, et al. 2021) studies suggested the feasibility of sequencing 223Ra and 177Lu-PSMA therapies. Here we used data from the observational, retrospective RALU study to further examine the safety and clinical outcomes of sequential 223Ra/177Lu-PSMA therapy in pts with mCRPC. Methods: This interim analysis investigated the baseline characteristics, safety (primary endpoint) and OS (secondary endpoint) in pts who received 177Lu-PSMA after 223Ra using retrospective data collected in German centers. Results: Data from 49 pts were available for this interim analysis. At baseline, before the start of 177Lu-PSMA, 73% of pts were Eastern Cooperative Oncology Group performance status (ECOG PS) 1 and 27% ECOG PS 2. Visceral metastases were present in 31% of pts. Median prostate-specific antigen (PSA) and alkaline phosphatase (ALP) were 287 ng/ml and 142 U/L, respectively (Table). 70% of pts received ≥4 life-prolonging therapies prior to 177Lu-PSMA, with abiraterone acetate (80%), enzalutamide (67%) and docetaxel (92%) being the most frequently used. 74% of pts received ≥5 223Ra injections. Pts received either PSMA-617 (67%) or PSMA I&T (33%): 65% of pts received 1–4 cycles and 33% received 5–6 cycles. Median duration of 177Lu-PSMA therapy was 4.9 months (m) (0–57.1). Median time from the last 223Ra dose to first 177Lu-PSMA dose was 9.3 m (0.9–41.9). Any grade treatment-emergent adverse events (TEAEs) from the start of 177Lu-PSMA therapy to 30 days of follow-up occurred in 91.8% of pts, and serious TEAEs in 20% of pts. Grade 3-4 hematologic laboratory abnormalities up to 90 days post-177Lu-PSMA occurred in 34.7% of pts for anemia, 12.8% for thrombocytopenia and 2.0% for neutropenia. No grade 5 toxicities occurred. 39% of pts had ≥30% decline in PSA during 177Lu-PSMA treatment. Median OS was 12.6 m (95% CI 8.8–16.1) from the start of 177Lu-PSMA therapy. Conclusions: In this real-world retrospective analysis of selected pts with advanced mCRPC, the 223Ra/177Lu-PSMA treatment sequence was clinically feasible and well tolerated. [Table: see text]
Alkaline phosphatase (ALP) decline and overall survival (OS) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 (Ra-223) in the REASSURE study.
Authors: James Nicholas D. , Heinrich Daniel , Castro Elena , George Saby , Song Daniel Y. , Dizdarevic Sabina , Baldari Sergio , Essler Markus , de Jong Igle Jan , Lastoria Secondo , Hammerer Peter G. , Meltzer Jeffrey , Sandstrom Per , Verholen Frank , Tombal Bertrand F. , O'Sullivan Joe M. , Sartor A. Oliver 
Published: June 2022

5041 Background: Ra-223 extends OS in pts with mCRPC. Predictive markers of response to Ra-223 are needed to help select pts who would benefit most from Ra-223 therapy. The ALSYMPCA study suggested a correlation between ALP decline and longer OS. Here, we evaluated whether ALP decline is associated with OS in the global real-world REASSURE study. Methods: Pts treated with Ra-223 were grouped by baseline ALP ≤147 U/L vs >147 U/L and any ALP decline vs no decline at week 12 from the first Ra-223 dose. The 147 U/L cut-off was selected based on the highest upper limit of normal for ALP from literature. Pts with a trend of decreasing ALP at closest value to week 12 between weeks 8 and 16 were included in the any decline group. Association of ALP decline with OS was assessed in the ≤147 U/L and >147 U/L groups separately. Median OS is provided with an unadjusted hazard ratio (HR) (95% confidence interval [CI]). Multivariate Cox models provided adjusted HRs (95% CI) for the association of ALP decline with OS. Some baseline covariates were not included in the models due to missing data. Results: 785 of 1465 pts had baseline ALP measurements, of whom 779 had week 12 ALP measurements: 443 had ≤147 U/L and 336 >147 U/L. In the ≤147 U/L group, median OS was 23.0 months (m) (95% CI 20.9–25.7) in pts with ALP decline (n=329) and 16.4 m (95% CI 14.1–20.4) in pts with no decline (n=114). In the >147 U/L group, median OS was 12.9 m (95% CI 11.7–14.3) in pts with ALP decline (n=295) and 8.1 m (95% CI 5.6–10.3) in pts with no decline (n=41). Comparison of unadjusted and adjusted HRs is shown in the Table. Conclusions: Pts with an ALP decline in first 12 weeks of Ra-223 treatment had longer OS. The effect of other baseline variables, including age, PSA, Hgb and prior treatments, provided adjustment but did not change this outcome. [Table: see text]
Outcome of patients with PSMA PET/CT screen failure by VISION criteria and treated with 177Lu-PSMA therapy: A multicenter retrospective analysis.
Authors: Hotta Masatoshi , Czernin Johannes , Gafita Andrei , Calais Jeremie 
Published: June 2022

5042 Background: The VISION trial showed that 177Lu-PSMA prolongs survival and improves the quality of life of patients with advanced mCRPC. It used PSMA-PET/CT to select patients for inclusion. The screen failure rate was “only” 12.6% (126/1003) and some have argued that the trial could have been positive even in an unselected population. It remains unknown whether the VISION-PET criteria were appropriate to stratify patients into likely responders versus non-responders to177Lu-PSMA. Here, we evaluated the outcome of patients who would have been excluded by the VISION-PET criteria and were nevertheless treated with 177Lu-PSMA. Methods: Patients treated with ≥1 cycle of 177Lu-PSMA between 11/2017 and 07/2021 (n = 74) who were registered in our institutional database and those enrolled in a multicenter dataset published previously (n = 230) (Gafita A, Lancet Oncol 2021) were retrospectively studied. One dual certified nuclear medicine and radiology reader reviewed baseline PSMA PET/CT studies and classified the patients as eligible (VISION-PET-E) or screen failure (VISION-PET-SF) based on the VISION-PET criteria: 1) absence of metastatic lesion(s) with uptake > liver background (i.e., low PSMA expression) or 2) presence of ≥ 1 metastatic lesion measurable by CT (≥ 1 cm for bone lesions with soft-tissue component (M1b) and solid/visceral organs lesions (M1c); ≥ 2.5 cm for lymph nodes lesions (N1-M1a)) with uptake ≤ liver background (i.e., PSMA-negative lesions). Outcome measures were PSA response rates (decline of ≥50% (PSA50RR), any decline (anyPSARR)), PSA-progression free-survival (PSA-PFS), and overall survival (OS). Results: 3/304 patients (1%) were excluded (lost to follow-up (n = 2), missing CT data (n = 1)). The median follow-up time was 22.5 (range: 2.1-62.3) months. 272/301 (90.4%) were VISION-PET-E, while 29/301 (9.6%) were VISION-PET-SF: 8/301 (2.7%) and 21/301 (7.0%) patients with low PSMA expression and PSMA-negative lesions, respectively. The VISION-PET-SF patients had worse PSA50RR (21% vs 50%; p = 0.005), anyPSARR (41% vs 71%; p = 0.003), median PSA PFS (2.1 months (95%CI: 1.1-3.3) vs. 4.1 (4.0-5.8); p = 0.023)), and tended to have a shorter OS (9.6 months (95%CI: 4.7-14.0) vs. 14.2 (12.6-15.9); p = 0.16) than the VISION-PET-E patients. Conclusions: VISION-PET-SF patients had worse outcomes than the VISION-PET-E patients. Our cohort only included patients who were eligible by each local site criteria. It did not include those 10-15% of patients who were excluded by local site assessment. Thus, 20-25% of the patients may be screen failures in unselected populations. Refinements in patient selection for 177Lu-PSMA are needed to optimize outcomes. Not characterizing target expression prior to PSMA-targeted treatment appears now non-ethical as a predictive whole-body imaging biomarker for response to PSMA-targeted therapies is available.
Tolerability of [177Lu]Lu-PSMA-617 by treatment exposure in patients with metastatic castration-resistant prostate cancer (mCRPC): A VISION study subgroup analysis.
Authors: Tagawa Scott T. , Armstrong Andrew J. , Krause Bernd J. , Herrmann Ken , Rahbar Kambiz , De Bono Johann S. , Adra Nabil , Desilvio Michelle , Messmann Richard , Holder Geoffrey , Chi Kim N. 
Published: June 2022

5047 Background: In the phase 3 VISION study, lutetium (177Lu) vipivotide tetraxetan ([177Lu]Lu-PSMA-617; 177Lu-PSMA-617) + protocol-permitted standard of care (SoC) improved clinical benefit and was generally well tolerated despite a higher rate of adverse events (AEs) than SoC alone. Here we assess AE incidence by exposure to 177Lu-PSMA-617. Methods: VISION was an international, open-label study of 177Lu-PSMA-617 in adults with PSMA-positive mCRPC previously treated with ≥ 1 androgen receptor pathway inhibitor and 1–2 taxane regimens. Patients received 177Lu-PSMA-617 (7.4 GBq every 6 weeks, ≤ 6 cycles) + SoC or SoC alone. rPFS and OS were primary endpoints; safety was a secondary endpoint. AE analysis by exposure to 177Lu-PSMA-617 was carried out in pre-specified subgroups. 177Lu-PSMA-617 cycle duration was generally ̃6 weeks and cycle 6 duration was until the earliest date of subsequent treatment, and date of last administration of randomized treatment (including SoC) + 30 days. The cycle of onset in which an AE first occurred in a patient at maximum grade was assessed. Results: The median duration of cycle of onset for cycles 1 to 5 was 6 weeks; for cycle 6, it was 26.6 weeks (Table). Of the 529 patients in the 177Lu-PSMA-617 group, 240 (45.4%) received ≤ 4 cycles and 289 (54.6%) received 5–6 cycles of treatment. In patients who received ≤ 4 or 5–6 cycles, 234 (97.5%) and 285 (98.6%) treatment-emergent AEs (TEAEs); 100 (41.7%) and 92 (31.8%) serious TEAEs; 205 (85.4%) and 246 (85.1%) treatment-related AEs; and 13 (5.4%) and 6 (2.1%) fatal TEAEs, respectively, were observed. Number of TEAEs and serious TEAEs by cycle of onset are shown in the Table. Conclusions: Over 50% of patients with mCRPC received 5–6 cycles of 177Lu-PSMA-617. For cycles 1–5, TEAEs occurred at every cycle, with similar frequency. More TEAEs were observed in cycle 6, reflecting its longer median duration than other cycles. Clinical trial information: NCT03511664. [Table: see text]
Bone biomarkers and overall survival (OS) in men with advanced hormone-sensitive prostate cancer (HSPC): Results from SWOG S1216, a phase III trial of ADT +/- orteronel.
Authors: Lara Primo "Lucky" N. , Mayerson Edward , Gertz Erik , Tangen Catherine , Goldkorn Amir , Van Loan Marta , Hussain Maha H. A. , Gupta Shilpa , Zhang Jingsong , Parikh Mamta , Twardowski Przemyslaw , Quinn David I. , Vogelzang Nicholas J. , Thompson Ian M , Agarwal Neeraj 
Published: June 2022

5071 Background: Circulating bone biomarkers (BB) are strongly prognostic for OS in castration-resistant PC (CRPC). We prospectively evaluated BB in men with HSPC in S1216, a trial that established new OS benchmarks. We sought to identify patient (pt) subsets with differential OS outcomes as defined by BB. Methods: Markers of bone resorption [CTx;PYD] & formation [CICP;BAP] were assessed. Pts were randomly divided into training (1/3) & validation (2/3) sets. In the training set, recursive partitioning of OS was used to identify the ideal dichotomous cutpoint for each BB & for a combination of biomarker split points to define prognostic groups. In the validation set, Cox PH models were used to assess impact of BB on OS, adjusted for pt & tumor characteristics. Adjusted odds ratios for 3-year OS based on BB & baseline clinical factors were developed using logistic regression to estimate receiver operating characteristic (ROC) curves. Results: Of 1,279 men, 949 had baseline BB. Median age–68y; median PSA-28 ng/dL; Gleason>7: 60%; Zubrod PS 0/1-97%. Values of BB at the median & at cutpoints maximized for OS were identified. For 3 of the BB, the cutpoint was at the ̃85th %ile; for PYD it was at the median. Recursive partitioning algorithms applied to the training set identified 4 groups with differential OS based on a dichotomous split of CTx in combination with additional CICP splits within each group. Hazard ratios (HR) for OS based on elevated BBs are shown. ROC analysis showed that only BAP & PYD had significantly higher AUC(0.73;0.74) compared to AUC of baseline clinical factors(0.71) w/ p=0.02 and 0.03 respectively. There was no evidence of BB x treatment interaction (all p>=0.2). Conclusions: In men initiating ADT for HSPC, elevated BB are strongly prognostic for worse OS. BB levels alone & in combination with pt/tumor characteristics identify unique subsets of men with high probability of being alive at 3 years from ADT initiation. These results validate the clinical value of BB in the HSPC state, extending BB utility beyond CRPC. Clinical trial information: NCT01809691. [Table: see text]
Prevalence of DNA damage repair (DDR) alterations in patients with metastatic hormone-sensitive prostate cancer (mHSPC) receiving enzalutamide (ENZA) or placebo (PBO) plus androgen deprivation therapy (ADT): ARCHES post hoc analysis.
Authors: Azad Arun , Iguchi Taro , Alekseev Boris , Shore Neal D. , Sugg Jennifer , Haas Gabriel P. , Wozniak Michele , O'Brien Thomas , Laird Douglas , Stenzl Arnulf , Armstrong Andrew J. 
Published: June 2022

5074 Background: DDR alterations are associated with poorer prognosis, including shorter overall survival (OS), in patients with mHSPC. In ARCHES (NCT02677896), patients with mHSPC treated with ENZA + ADT had a reduced risk of radiographic progression or death and improved OS versus PBO + ADT. This post hoc analysis assessed the prevalence of DDR alterations and associated baseline characteristics in patients with mHSPC in ARCHES. Methods: Patients with mHSPC (n=1150) were randomized 1:1 to ENZA (160 mg/day) + ADT or PBO + ADT. Germline DDR alteration testing was performed in blood using Ambry Genetics CustomNext-Cancer panel; 16 DDR-related genes were reported in the subset of patients who consented to participate in a pharmacogenomic study (n=664; Table). Descriptive analyses of baseline demographics and disease characteristics by DDR status were performed. Results: Of 664 patient samples tested, 652 were evaluable for analysis (ENZA + ADT, n=326; PBO + ADT, n=326). Baseline characteristics of these patients were similar to the ARCHES intent-to-treat population. The prevalence of DDR+ patients was lower than expected (n=34/652, 5.2%; Table). Of DDR+ patients, 13 (38.2%) had low-volume disease, compared with 228 (36.9%) of DDR− patients. High-volume disease was present in 21 (61.8%) DDR+ and 390 (63.1%) DDR− patients. Of DDR+ patients, 6 (17.6%) had localized disease at initial diagnosis (M0), compared with 145 (23.5%) DDR− patients. De novo metastatic disease at initial diagnosis (M1) was present in 28 (82.4%) DDR+ patients and 465 (75.2%) DDR− patients. Of DDR+ patients, 29 (85.3%) were from Europe, four (11.8%) were from North America, and one (2.9%) was from the Asia-Pacific region. Conclusions: This post hoc analysis found a lower prevalence of DDR alterations in patients with mHSPC in ARCHES, compared with the 7–12% previously reported in patients with metastatic castration-resistant prostate cancer (Lozano et al. Br J Cancer 2021; Pritchard et al. N Engl J Med 2016). We did not identify differences in baseline disease characteristics based on DDR status. Clinical trial information: NCT02677896. [Table: see text]