tbuckley/cabot-search huggingface dataset:
Patient satisfaction with geriatric and functional assessments and referral to frailty-related interventions among older adults presenting to the University of Colorado Urologic Oncology Multidisciplinary Clinic.
Authors: Mohamoud Ahmed, Aditya Mantha, Stephanie Lakritz, Franchesca Konig, Elizabeth R. Kessler
Journal: Journal of Clinical Oncology (2025)

TPS273 Background: Geriatric assessments (GA) are valuable tools for determining the functional age of patients and represent the standard of care in evaluating vulnerabilities in older adults with cancer. In oncological treatment, these assessments can help refer patients to appropriate ancillary resources, such as physical therapists, registered dietitians, and social workers, while also assisting in selecting chemotherapy regimens, surgical interventions, and radiation therapy plans. GA and GA-guided management have been shown to positively impact treatment completion and reduce chemotherapy-related toxicity in two recent randomized clinical trials. However, there is minimal data assessing patient satisfaction with the interventions provided through this assessment. This study aims to evaluate patient experiences and acceptance of GA and fragility-based referrals recommended by GA, while also identifying patient-reported barriers to accessing these referred resources. Understanding patient acceptability towards geriatric and functional assessments, along with the determinants and barriers to referral completion, can provide additional information to improve oncologic care for older patients. Methods: This is a single-center feasibility study enrolling patients aged 65 and older who are diagnosed with genitourinary cancer and present to the University of Colorado Urologic Oncology multi-disciplinary conference (MDC). The primary endpoint is the patient-reported acceptability of incorporating geriatric and functional assessments. The secondary endpoint is patient-reported determinants and barriers to completing appropriate referrals based on findings from the GA. Patients will undergo a Practical Geriatric Assessment (PGA) and a Stopping Elderly Accidents, Deaths, and Injuries (STEADi) assessment. Based on their functional score, patients will be referred to Cancer Rehabilitation Medicine, physical therapy, occupational therapy, or the BfitBwell exercise program. Additionally, if the patient’s weight has decreased by more than 3 kilograms in the 3 months prior to their visit, they will be referred for nutritional support. Patients will also be referred to social services if they report significant concerns regarding their ability to manage daily living activities or if they lack adequate social support. Patient acceptability will be collected using validated acceptability of intervention surveys. Semi-structured qualitative interviews will be conducted 8 weeks after the patient’s MDC visit, focusing on patient-reported determinants and barriers to completing fragility-related referrals.
Prostate Cancer Real World Evidence Registry (PROCARE): Recurrent and metastatic prostate cancer.
Authors: Boris A. Hadaschik, Gunhild Von Amsberg, Ken Herrmann, Axel Stuart Merseburger, Peter J. Goebell, Erik Belleville, Peter A. Fasching, Lothar Haeberle, Andrea Roessler, Marc-Oliver Grimm
Journal: Journal of Clinical Oncology (2025)

TPS274 Background: Prostate cancer remains the most common malignancy among men and the fifth leading cause of cancer-related mortality globally. Over the past 15 years, advances in imaging techniques and therapeutic options have significantly transformed the management of recurrent, advanced, and metastatic prostate cancer. However, treatment efficacy and toxicity are highly influenced by prior therapy sequences, highlighting the need for a deeper understanding of the optimal treatment sequence. The prospective real-world evidence registry, PROCARE, addresses this gap by documenting treatment patterns, imaging exams, oncologic outcomes, and safety profiles in routine clinical practice. Methods: This study focuses on four distinct patient cohorts: biochemical recurrence after local treatment with curative intent (e.g. radical prostatectomy, radiotherapy of the prostate or combination thereof), non-metastatic castration-resistant prostate cancer (nmCRPC), metastatic hormone-sensitive prostate cancer (mHSPC), and metastatic castration-resistant prostate cancer (mCRPC). PROCARE is a comprehensive long-term follow-up registry designed to document treatment patterns and outcomes in patients receiving systemic treatment. The study aims to enroll 5,000 patients across 50 sites in Germany. Recruitment is being conducted independently for each cohort, beginning with the mHSPC and mCRPC cohorts. First patient in was in January 2024. Patients will remain in the registry from the time of enrollment until death, withdrawal of consent, or study cohort closure. Throughout the study, additional blood samples will be collected at baseline and with each treatment change, respectively, and at first routine follow-up visit thereafter for exploratory research purposes, such as assessing circulating tumor DNA and RNA, as well as genome-wide single nucleotide polymorphisms (SNPs). This approach will enable a deeper understanding of treatment distribution, sequencing, efficacy, and safety in the real-world setting, contributing valuable insights into the evolving therapeutic landscape. Furthermore, analyses from liquid biopsies might provide important insights potentially guiding future therapeutic strategies for recurrent and metastatic prostate cancer. Clinical trial information: DRKS00033411 .
OCOG-RATIONAL: A phase II randomized trial of optimal recurrence-directed therapy (RDT) without or with androgen-deprivation therapy (ADT) in radio-recurrent oligo-metastatic castrate sensitive prostate cancer (romCSPC).
Authors: Theodoros Tsakiridis, Andre Gouveia, Aruz Mesci, Peter Vavassis, Alejandro Berlin, Scott C. Morgan, Nathan Perlis, Tamim Niazi, John Thoms, Sebastien J Hotte, Jim Wright
Journal: Journal of Clinical Oncology (2025)

TPS305 Background: This is a Canadian, multi-center study that investigates whether addition of ADT to RDT improves oncological outcomes in early romCSPC. The primary outcome is a 36-month composite Progression-free survival (cPFS). Secondary outcomes include metastasis-free survival, time to salvage therapy, time to castrate-resistant PC, OS, Quality of Life and toxicity. Methods: Population: Patients with biochemical recurrence after definitive or adjuvant/salvage radiotherapy for localized prostate cancer (PC) with oligo-metastatic disease (≤5 sites) without or with local recurrence. All patients will be staged with conventional imaging (CT/BS), mpMRI, PSMA-PET and biopsy of the prostate if in situ. Randomization: Patients are randomized 1:1 to RDT versus RDT+ADT for 12 months and stratified for, i) presence of local recurrence (Y/N), ii) volume of metastatic disease [0 (local recurrence alone) versus 1-3 versus 4-5 metastases]. iii) treatment centre, and iv) metastasis detected on conventional imaging (Y/N). Interventions: RDT options include Stereotactic Body Radiotherapy (SBRT), hypo-fractionated radiotherapy (HFRT), brachytherapy and surgical resection. Concurrent and adjuvant ADT involves four 3-month leuprolide acetate injections. Statistics: A clinically meaningful improvement for the use of ADT is defined as an improvement in the 30-month cPFS of ≥20% (from 50% to 70%). With an expected accrual period of 3 years, an additional 1 year of follow-up, a 1-sided log-rank test with α=0.05 would have over 80% power to distinguish between the two group with 73 patients in each arm. This number is inflated by 10% for stratification factors and patients lost-to-follow-up, for a total of 162 patients. Coordination: The study is coordinated by the Ontario Clinical Oncology Group (OCOG) and is expected to open in 10-12 institutions across Canada. This trial will provide evidence on the impact of ADT in romCSPC managed with optimal recurrence directed therapy. Findings will support phase III trial design to help define the optimal management of romCSPC in the future. Clinical trial information: NCT06654336 .
Inclusion of patients with reduced performance status (ECOG 2 or higher) in FDA registrational trials for urothelial cancer.
Authors: Panah Parab, Ronit Juthani, Kala Seetharaman
Journal: Journal of Clinical Oncology (2025)

680 Background: The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is a tool used to describe a cancer patient’s functional status and recruit participants into clinical trials. Clinical trials recruit patients with a good performance status (ECOG 0 or 1) which is not concordant with the real-world population. ASCO-Friends of Cancer Research in a joint statement has recommended the inclusion of patients with reduced PS in clinical trials. We evaluated the inclusion of patients with ECOG 2 or greater in urothelial cancer clinical trials leading to FDA approvals between 2014 and 2024. Methods: The US Food and Drug Administration (FDA) website was searched for all the drugs or drug combinations approved for the treatment of urothelial cancer in the last 10 years. We used identifiers like the drug name, trial name, and registration number to retrieve data on participant ECOG scores from public databases. The data was then tabulated and trends were analyzed. Results: The US FDA approved 16 drugs and combinations for the treatment of urothelial cancer from 2014-2024. The trials for these drugs enrolled a total of 5621 participants, of which only 107 (1.9%) belonged to ECOG PS 2 or more. ECOG data was not available for OLYMPUS trial. Only one of the trials included 3 participants with ECOG 3. Five trials did not have any participants belonging to ECOG 2 or higher. Most of the trials had percentage enrollment of ECOG 2 &lt;10% except EV-201. Conclusions: Participants with ECOG 2 and greater have minimal enrolment in registrational clinical trials of urothelial cancer. This limits the options available for treatment of urothelial cancer in patients with reduced PS. Greater inclusion of poor PS patients is needed in future trials for greater health equity. Clinical trial Year Reduced PS% (ECOG 2 or higher) QUILT-3.0320 2024 3.5% BLC3001 2024 9.4% EV-302/KN-A39 2023 2.9% nadofaragene firadenovec-vncg 2022 2.5% CHECKMATE-274 2021 2.3% EV-201 2019 12.4% JNJ-42756493 2019 7.1% KEYNOTE-045 2017 1.1% CHECKMATE-901, EV-301, TROPHY, JAVELIN Bladder 100, KEYNOTE-057, durvalumab, atezolizumab 2016-2024 &lt;1%
LuCarbo: A phase 1a/1b trial of <sup>177</sup> Lu-PSMA-617 (LuPSMA) with carboplatin in advanced prostate cancer.
Authors: Praful Ravi, Wanling Xie, Morgan Paul, Erin Healy, Amanda Lilienfeld, Nicole LaBrecque, Andrew Wolanski, Jolivette Ritzer, Michael Thomas Serzan, Alok Tewari, Heather Jacene
Journal: Journal of Clinical Oncology (2025)

TPS304 Background: LuPSMA is a proven life-prolonging therapy in men with metastatic castrate-resistant prostate cancer (mCRPC) who have previously received a taxane and an androgen receptor pathway inhibitor (ARPI). Despite patient selection by PSMA-PET/CT, responses are only seen in 50% of patients with PSMA-avid disease and are generally not durable. The mechanism of LuPSMA relies on delivery of beta emissions upon target engagement, thereby leading to DNA damage. Carboplatin is an inexpensive and widely available agent used as a radiosensitizer in other solid tumors and often combined with a taxane in CRPC. Given the need to improve outcomes with LuPSMA and the mechanisms of action of both agents, there is a rationale to evaluate the combination of LuPSMA with carboplatin in mCRPC. Methods: This is a single-center phase 1a/1b trial of LuPSMA and carboplatin. Patients with mCRPC who have previously received ≥1 taxane and ≥1 ARPI and have PSMA-avid disease on baseline PSMA-PET/CT are eligible. LuPSMA is given at the standard dose of 7.4GBq every 6 weeks, and carboplatin is dosed every 3 weeks, with 6 weeks constituting 1 cycle. In phase 1a, a 3+3 design is used with 3 planned dose levels of carboplatin (DL1 – AUC2; DL2 – AUC3: DL3 – AUC4); the dose-limiting toxicity (DLT) period is during cycle 1, and the recommended phase 2 dose (RP2D) will be the highest administered dose level with ≤1 DLTs out of 6 treated patients. In phase 1b, 19 patients will be enrolled at the RP2D (for a total of 25 patients treated at RP2D), and these patients will additionally undergo baseline and on-therapy research biopsies and an on-therapy PSMA-PET/CT after 2 cycles. The primary objective is to evaluate the safety of the combination and establish the RP2D; secondary objectives include overall response rate (PSA50 – reduction in PSA by ≥50% - and objective response rate, per RECIST 1.1), radiographic progression-free survival (per RECIST 1.1/PCWG3) and overall survival. Exploratory objectives include evaluation of genomic, transcriptomic, proteomic, and imaging biomarkers of response and resistance. With a sample size of 25 patients treated at RP2D, the combination will be deemed effective if 15 or more PSA50 responses are seen; the probability of concluding that the combination is effective is ≤0.1 if its true PSA50 rate is ≤45% and ≥0.9 if the true PSA50 rate is ≥70%. The study was activated in May 2024, and a total of 6 patients have been enrolled to date. Clinical trial information: NCT06303713 .
The effect of circadian rhythm–based medication timing adjustments on the efficacy and safety of novel hormonal therapy.
Authors: Junliang Zhao, Diwei Zhao, Yuanwei Li, Xinyang Cai, Zhenyu Yang, Fangjian Zhou, Yonghong Li, Jun Wang
Journal: Journal of Clinical Oncology (2025)

TPS277 Background: Neoadjuvant hormonal therapy (NHT) serves as the primary treatment approach for metastatic hormone-sensitive prostate cancer (mHSPC) by either inhibiting androgen synthesis or blocking androgen receptor binding, thereby suppressing tumor growth. Despite its effectiveness, patients with mHSPC inevitably develop resistance to NHT over time, advancing to metastatic castration-resistant prostate cancer (mCRPC), which is associated with a poor prognosis. Androgen synthesis and secretion exhibit a prominent circadian rhythm, with accelerated synthesis in the early morning, peaking around 8:00 AM, followed by a decline to nadir by approximately 8:00 PM. Administrating NHT agents during nighttime may enhance therapeutic efficacy by preemptively inhibiting androgen synthesis and receptor binding before the peak secretion period. Consequently, we have designed a prospective study to evaluate and compare the efficacy and safety of daytime versus nighttime administration of NHT agents in patients with mHSPC. Methods: This prospective, open-label, phase II study will enroll 70 patients with mHSPC. Key eligibility criteria include histologically or pathologically confirmed prostate cancer, classified as mHSPC, without prior NHT or chemotherapy. Patients currently receiving other systemic antitumor therapies, those who have undergone organ transplantation within the past 3 months, or been diagnosed with autoimmune disease will be excluded. Eligible patients will be randomized in a 1:1 ratio to receive NHT agents either between 7:00 and 9:00 AM or between 10:00 and 12:00 PM. Treatment is continued until disease progression. The primary objective is to evaluate the effect of nighttime administration of NHT agents by assessing PSA response rate (PSA-RR), defined as the proportion of patients achieving &gt; 90% reduction in PSA from baseline after 3 months of NHT. Secondary endpoints include circulating tumor cell (CTC) clearance rate, clinical benefit rate, objective response rate (ORR), duration of response (DoR), time to objective response, radiographic progression-free survival (rPFS), overall survival (OS), and treatment-emergent adverse events (TEAEs). Differences in response rates between the 2 groups will be analyzed using the Chi-square test. Survival endpoints will be estimated using the Kaplan-Meier method, with between-group comparisons conducted by the log-rank test. Currently, 14 of a planned total of 70 participants have been enrolled. Clinical trial information: NCT06505278 .
Trends in inpatient outcomes of bladder cancer: 2008-2021.
Authors: Ayobami Gbenga Olafimihan, Inimfon Nsikak Jackson, Olanipekun Lanny Ntukidem, Oboseh John Ogedegbe, Hafeez Shaka
Journal: Journal of Clinical Oncology (2025)

674 Background: Bladder cancer is a common malignancy of the urinary tract that is associated with about 16,840 estimated deaths in 2024. With the recent advances in bladder cancer treatment, it is unknown whether the trends in hospitalization outcomes have changed over time. We evaluated the trends in hospitalization outcomes among patients with a diagnosis of bladder cancer. Methods: This is a retrospective longitudinal trends study using the Nationwide Inpatient Sample (NIS) database (2008-2021). We identified hospitalizations with bladder cancer using ICD-9 and ICD-10 codes. Multivariate logistic and linear regression models were used to examine the trends in mortality outcomes stratified by demographic subgroups (age, gender and race). Results: There were over a million (1,123,567) hospitalizations with bladder cancer between 2008 and 2019. 73.5% were males; The mean age of the patients was 73.5 years. There was an overall increase in mortality amidst admissions with bladder cancer, from 4.5% in 2008 to 4.9% in 2021 (adjusted odds ratio [aOR]: 1.01; P-trend = 0.010). In the age subgroup, elderly patients (≥65 years) had an increase in mortality (aOR: 1.007; P-trend = 0.028). The young adults (18 - 44 years) and middle-aged adults (45 - 64 years) had no significant change in mortality rate (P-trend = 0.31 and P-trend = 0.131 respectively). For gender subgroup analysis, worse mortality outcomes were seen for males (aOR:1.01; P-trend=0.001); females had similar mortality over the period (P-trend=0.53). Racial subgroup analysis showed increased mortality outcomes for non-Hispanic White patients (aOR:1.01; P-trend=0.03). Black (P-trend=0.77) and Hispanic (P-trend=0.46) patients had no significant change in mortality outcomes. Conclusions: There was an overall increase in hospital mortality outcomes for bladder cancer patients from 2008-2021. While treatment advances continue to show improvement in survival outcomes, efforts are needed to ensure that hospitalized patients with bladder cancer have improved mortality outcomes. Inpatient mortality trends of bladder cancer stratified by demographic subgroups. Adjusted Odds Ratio P-Trend 95% Confidence Interval Overall Mortality 1.01 0.010 1.002-1.014 Young adults (18 - 44 years) 1.03 0.31 0.971-1.099 Middle-aged adults (45 - 64 years) 1.01 0.131 0.997-1.024 Elderly patients (≥65 years) 1.01 0.028 1.001-1.014 Male 1.01 0.001 1.005-1.019 Female 1.0 0.53 0.986-1.007 Non-Hispanic White 1.01 0.03 1.001-1.015 Black 1.00 0.77 0.979-1.016 Hispanic 0.99 0.46 0.968-1.015
Final overall survival and new ctDNA analysis in MET-driven advanced papillary renal cancer (CALYPSO).
Authors: Francesca Jackson-Spence, James Larkin, Poulam Patel, Begoña P. Valderrama, Alejo Rodriguez-Vida, Maria Jose Mendez-Vidal, Merrida Childress, Wenshu Li, Patrick Boyle, Amaya Gasco, Aleksandra Markovets, Ryan James Hartmaier, Charlotte Ackerman, Bernadett Emma Szabados, Garima Priyadarshini, Fahmida Jamal, Thomas Powles, Cristina Suárez
Journal: Journal of Clinical Oncology (2025)

444 Background: Phase II data from the CALYPSO study (NCT02819596) has shown activity for durvalumab (PD-L1 inhibitor) plus savolitinib (MET inhibitor) (D+S) in MET-driven advanced papillary renal cancer (aPRC), resulting in the ongoing randomised phase III study, SAMETA (NCT03091192). Here we present the final efficacy and new ctDNA analysis. Methods: The aPRC cohort was a single arm study of D+S in both untreated and previously treated disease. Efficacy endpoints include response rates (RR) as per RECIST 1.1, progression-free survival (PFS) and overall survival (OS). PD-L1, TMB and MET status were analysed. Safety was assessed via CTC criteria. FoundationOne CDx was used to profile tissue in 41 patients. Plasma was collected for ctDNA analysis (FoundationOne Tracker analysis; n=21) at baseline (pre-treatment) and sequential time points on treatment. MET mutations were also tracked using F1 Tracker following identification by the F1CDx assay. Results: At 41 months follow-up, the RR in the Intention to Treat (ITT) aPRC population (n=41) was 34% (95% CI, 20-51) and 59% (95% CI, 33-82) in MET-driven patients (n=17). The median PFS was 8.4 months (95% CI, 3.0-13.9) in the ITT population and 16.7 months (95% CI, 5.1-31.4) in MET-driven patients. The median OS was 18.3 months (95% CI, 7.3-30.6) in the ITT population and 27.4 months (95% CI, 9.3-51.6) in MET-driven patients. The hazard ratio (HR) for PFS and OS in MET-driven vs non-MET-driven in PRC cohort was 0.36 (p=0.02) and 0.76 (p=0.43), respectively. 66% of patients were PD-L1+, and 32% were both MET-driven/PD-L1+. The PD-L1 biomarker did not enrich for responders. 27% patients had tissue TMB &gt;median (2.52mut/Mb). TMB was not associated with outcome. 10/16 (63%) were ctDNA positive at baseline, which was associated with a shorter median OS of 7.3 vs 36.4 months (HR 3.91, p=0.02). The mean reduction in Variant Allele Frequency (VAF) was 43% with therapy. For patients with pre- and on-treatment ctDNA, those with CR/PR had ctDNA VAF reduction while those with SD/PD had ctDNA VAF increase (p=0.05). ctDNA clearance was associated with improved PFS (p=0.04). Only 2 patients had MET mutations tracked. ctDNA positivity did not correlate with MET alterations, PD-L1 status or the presence of visceral metastases. Conclusions: D+S continue to show impressive efficacy in MET driven tumors, supporting the ongoing SAMETA trial. ctDNA monitoring on therapy holds promise as a prognostic and potentially predictive tool in this setting. Clinical trial information: NCT02819596 .