bluuebunny/crossref_metadata_2025 huggingface dataset:
Impact of physicians’ awareness of prostate-specific antigen doubling time (PSADT) on treatment (Tx) decisions in high-risk (HR) biochemically recurrent (BCR) prostate cancer (PC).
Authors: Morgans Alicia K. , Touya Maelys , El-Chaar Nader N. , Elsouda Dina , Ramaswamy Krishnan , Adejumo Kelechi L. , Gentile Danielle , Feinberg Bruce A. , Asgarisabet Parisa , Pathak Prathamesh , Freedland Stephen J.
Published: February 2025

354

Background:
PSADT is one of the strongest predictors of outcomes in patients (pts) with BCR PC and a criterion for HR BCR definition. As such, it is crucial to determine whether physicians are aware of pts’ PSADT and how this influences Tx in routine practice. We compared Tx patterns in pts with HR BCR whose PSADT was known (kPSADT) or unknown (uPSADT) by the physician.
Methods:
This physician-abstracted chart review used data of pts with HR BCR from the Cardinal Health Oncology Provider Extended Network (2018–2020) in the US. HR BCR definition: PSADT ≤9 months (mo) with PSA at or above the threshold per the EMBARK trial. Follow-up was from the index date (date on which HR BCR definition was met) until disease progression, last follow-up, or death through 2022. Physicians reported PSADT in case report forms (CRFs) using doubling time from labs, clinical judgement, or an online calculator (kPSADT). If not provided in the CRF, PSADT was calculated retrospectively based on PSA values up to the index date that the physician had entered in the CRF (uPSADT). We analyzed time to treatment after index via the Kaplan–Meier method.
Results:
Among 284 pts with HR BCR, median time from initial PC diagnosis to the end of follow-up was 39.1 mo; most pts had kPSADT). There were differences between in age, time from localized PC diagnosis to BCR, Gleason score, and PSA at initial diagnosis and at BCR (Table). A higher proportion of pts with uPSADT had a fast PSADT (≤3 mo) (61% vs 20%,
P
< 0.001). A higher proportion of pts with kPSADT (64%) vs uPSADT (17%) received Tx within 60 days after index, with a shorter median time to Tx (1.0 vs 6.7 mo; HR: 3.4, 95% CI: 2.6–4.4,
P
< 0.0001).
Conclusions:
Most physicians did not know their pts’ PSADT. Even though pts with HR BCR PC who had kPSADT were older and had slower PSADT, they were over three times more likely to receive Tx vs pts with uPSADT. The results suggest that many pts with HR BCR PC may be missed in clinical practice, which limits these pts’ opportunity to receive guideline-concordant Tx to delay progression.

Characteristics of index
kPSADTn = 104
uPSADTn = 180

P
value

Age (years), mean (SD)
70.0 (7.6)
65.6 (7.0)
<0.001

Primary definitive PC Tx, n (%)

Radiotherapy
28 (27)
51 (28)

Prostatectomy
76 (73)
129 (72)

Time from localized PC diagnosis to BCR ≤2 years, n (%)
97 (93)
143 (79)
0.002

Gleason score ≥8, n (%)
76 (73)
81 (45)
<0.001

PSA before initial localized PC diagnosis (ng/mL), median (IQR)
9.0 (6.7)
7.9 (8.6)
0.019

PSA at BCR (ng/mL), median (IQR)
3.4 (9.0)
2.6 (2.8)
<0.001
Impact of the 2012 and 2018 USPSTF statements on prostate cancer screening and metastatic rates in Kaiser Permanente Northern California.
Authors: Presti Joseph , Horton Brandon , Alexeeff Stacey , Prausnitz Stephanie , Avins Andrew
Published: February 2025

359

Background:
To assess how the United States Preventive Services Task Force (USPSTF) Prostate Cancer Screening Statements of 2012 (Grade D - “recommends against”) and 2018 (Grade C - “selectively offering...based on professional judgment and patient preferences”) influenced race-specific rates of PSA screening and metastatic cancer at presentation among screen-eligible men in Kaiser Permanente Northern California.
Methods:
This is a retrospective study from 2006 to 2022, in screen-eligible (ages 50-69), Kaiser Permanente Northern California members. We compared the race-specific rates of PSA screening and metastatic cancer at presentation before and after the changes in the USPSTF Statements.
Results:
In 2006 there were 324,950 screen-eligible men (11% Black, 17% Asian, 73% White). In 2022 there were 434,705 screen-eligible men (11% Black, 27% Asian, 63% White). Race-specific, annual screening and metastatic rates are shown (Table). Following the 2012 USPSTF statement, all races experienced similar declines in screening and an increase in metastatic rates which was greatest among Black men. Following the 2018 statement, all races experienced similar increases in screening (with the exception of the time around the pandemic in 2020); yet as of 2022, the rate of metastatic cancer has continued to increase.
Conclusions:
The 2012 USPSTF Statement (Grade D) was associated with a decline in screening and an increase in metastatic rates among all races, yet was greatest among Black men, a high-risk group. Following the 2018 USPSTF Statement (Grade C), screening rates have increased yet metastatic rates continue to rise and remains greatest among Black men.

Biennial race-specific screening and metastatic rates.

2006
2008
2010
2012
2014
2016
2018
2020
2022

Screening Rates(per 100,000 person-yrs)

Asian
477
511
512
453
406
370
380
262
432

Black
441
452
468
398
364
328
338
255
381

White
438
461
455
398
354
315
329
242
384

Metastatic Rates(per 100,000 person-yrs)

Asian
0.06
0.22
0.08
0.06
0.12
0.20
0.25
0.16
0.34

Black
0.44
0.34
0.33
0.31
0.66
0.76
0.85
0.72
1.18

White
0.26
0.23
0.19
0.17
0.30
0.31
0.42
0.48
0.73
Real-world U.S. county-level analysis of erectile dysfunction diagnosis following radiation therapy for localized prostate cancer: The impact of rectal spacer utilization.
Authors: Hankins Ryan , Sato Ryoko , Mehta Parthiv , Bhattacharyya Samir , Ezekekwu Emmanuel , Collins Sean P.
Published: February 2025

365

Background:
Rectal spacers have been shown to reduce side effects of prostate radiotherapy (RT) in prostate cancer (PCa) patients in clinical studies. While rectal spacing may help preserve sexual function after RT, this association has not been explored in large-scale real-world data. This study evaluated the association between rectal spacer use and the prevalence of erectile dysfunction diagnosis among PCa patients receiving prostate RT at the U.S. county level.
Methods:
This study utilized Medicare 5% and 100% Standard Analytic Files to analyze county-level data. The population consisted of adult PCa patients receiving RT (IMRT, brachytherapy, SBRT, or proton therapy) between 2015 and 2022. The primary outcome was the county-level proportion of patients diagnosed with erectile dysfunction in any year between 2016 and 2023. The primary explanatory variable was the proportion of patients treated with RT using rectal spacer 1 to 5 years before erectile dysfunction diagnosis. Zero-inflated Poisson regression models assessed the association between rectal spacer use and erectile dysfunction diagnosis at county level, controlling for county-level PCa patients characteristics (average age and racial composition) and general population characteristics (median age, racial composition, and median household income). State-level fixed accounted for regional variation. Data for the general population were obtained from the Agency for Healthcare Research and Quality Social Determinants of Health Database 2020.
Results:
The study included 247,250 PCa patients receiving prostate RT during the study period across 3,132 U.S. counties. The average annual prevalence of erectile dysfunction diagnosis among PCa patients receiving RT at the county level was 1.3%. The proportion of patients receiving rectal spacers increased from 2.9% to 18.9% over the study period. After adjusting for confounders, counties with higher rectal spacer use 4-5 years prior had a significantly lower prevalence of erectile dysfunction diagnosis. A 10-percentage point increase in rectal spacer usage at the county level was associated with a 7.7% reduction in erectile dysfunction diagnosis after 4 years (p<0.001) and an 8.4% reduction after 5 years (p=0.006).
Conclusions:
In this first assessment of a real-world dataset, the county-level analysis suggests that increased use of rectal spacing among PCa patients receiving prostate RT is associated with a significantly lower prevalence of erectile dysfunction, with a time lag of 4 to 5 years. This finding supports the long-term benefit of rectal spacing in preserving sexual function in PCa patients undergoing prostate RT. Future research should evaluate the etiology of the longer than expected time lag between utilization and benefit.
Real-world discontinuation and efficacy data of abiraterone acetate/prednisone (AAP) plus androgen deprivation therapy and radiotherapy in localized prostate cancer.
Authors: Di Costanzo Fabrizio , Jiang Xue Yan , Frew John A. , Pedley Ian , Shakespeare Emma , Lagonera Mariajulia , Haris Noor Md , Bashir Saira , Plummer Ruth , Greystoke Alastair , Oing Christoph , Formisano Luigi , Rescigno Pasquale , Chandler Robert
Published: February 2025

367

Background:
Data from STAMPEDE trial confirmed Overall survival benefit for patients with high-risk localized or locally advanced prostate cancer treated with Radiotherapy (RT) plus 24-month Abiraterone/prednisone (AAP) and ADT. Nevertheless, a 17% discontinuation rate in the experimental arm of the trial was reported. Here we present a cohort of patients treated with this regimen at two Institutions.
Methods:
We conducted a retrospective analysis of patients with localized or locally advanced prostate cancer who underwent treatment with AAP+ADT+RT with at least 18 months of follow-up. Primary endpoint was the discontinuation rate of AAP in the ITT population. Secondary endpoints included PSA decline rate, PSA nadir <0.02 ng/mL and safety. Clinical data were collected from patients’ electronic records. GraphPad Prism software was used for chart design, data comparison and statistical analysis.
Results:
Overall, 104 patients completed RT (60 Gy in 20#) and met inclusion criteria for this analysis. Of them, 61 (58.7%) patients had N0 disease, while 43 (41.3%) had N1 disease. AAP was discontinued prior the pre-planned two years in 29/104 (27.9%) patients. Among those who discontinued, median duration of AAP was 13.5 mo [3.2-23.5], while median duration of ADT was not reached [6.1-35.9]. Reasons for AAP discontinuation included hepatotoxicity (n=8), heart concerns and oedema (n=7 and 2, respectively), brain fog (n=2), hypokalaemia (n=2), quality of life deterioration (n=5), other (n=3). In total, 73/104 patients (70.2%) reached a PSA nadir <0.02 ng/mL at the 18-month analysis. No significant difference in achieving a PSA < 0.02 ng/mL was seen between those stopping AAP early (20/29 - 69%) and those who didn't (53/75 - 70.7%).
Conclusions:
Our analysis revealed a notably high rate of early discontinuation of AAP in the real-world setting in patients treated for their localized prostate cancer when compared to what observed in the STAMPEDE trial. Nonetheless, early discontinuation did not negatively impact on short-term treatment efficacy as a possible surrogate for long-term treatment benefit. Future studies on larger populations with longer follow-up are warranted to confirm these results.
Real-world treatment patterns and outcomes of novel androgen receptor axis-targeted agents in non-metastatic castration-resistant prostate cancer: A multi-institutional retrospective study.
Authors: Fujita Naoki , Yoneyama Fumiya , Kawashima Yohei , Tanaka Ryuma , Oishi Takuya , Miura Hikari , Okita Kazutaka , Ohyama Chikara , Hatakeyama Shingo
Published: February 2025

368

Background:
Recently, three phase III trials have demonstrated that novel androgen receptor axis-targeted agents (ARATs) significantly improved metastasis-free survival (MFS) and overall survival (OS) compared to placebo in patients with non-metastatic castration-resistant prostate cancer (nmCRPC). However, the treatment patterns and outcomes of novel ARATs in real-world settings remain unclear.
Methods:
This multi-institutional retrospective study included 245 patients with nmCRPC treated between September 2003 and April 2024. Trends in the use of novel ARATs were evaluated. Patients were divided into two groups: those who were treated with any novel ARATs, including apalutamide, enzalutamide, darolutamide, and abiraterone acetate, during any line of nmCRPC treatment (novel ARATs group) and those who were not (control group). Multivariable Cox proportional hazards regression analyses were performed to evaluate the effects of novel ARATs on MFS and OS. Adverse events (AEs) associated with novel ARATs were evaluated using the Common Terminology Criteria for Adverse Events version 5.0.
Results:
The median age and follow-up period after nmCRPC diagnosis were 77 years and 45 months, respectively. Of the 245 patients, 175 (71%) were treated with novel ARATs after nmCRPC diagnosis. Novel ARATs use in first line and any line was gradually increased from 2014 to 2023 (0% to 85% and 38% to 92%, respectively). The MFS and OS in the novel ARATs group were significantly longer than those in the control group (
P
< 0.001 and
P
= 0.001, respectively). In multivariable analyses, a prostate-specific antigen doubling time (PSADT) and novel ARATs were independently and significantly associated with MFS and OS (Table). The rate of grade 3 AEs and discontinuation due to AEs were 1.1% and 6.0%, respectively.
Conclusions:
The use of novel ARATs for the treatment of nmCRPC increased over time. Novel ARATs use was safe and associated with improved oncological outcomes in a real-world setting.

Multivariable analyses for MFS and OS.

MFS
Factor

P
value

Hazard ratio
95% CI

Age
Continuous
0.003
0.956
0.928–0.984

Time of nmCRPC diagnosis
Before 2014
0.706
0.917
0.584–1.439

PSADT
<2.5 months
<0.001
2.040
1.339–3.107

Novel ARATs
Positive

<0.001

0.364

0.238–0.557

OS
Factor

P
value

Hazard ratio
95% CI

Age
Continuous
0.418
1.014
0.980–1.049

Time of nmCRPC diagnosis
Before 2014
0.626
0.883
0.537–1.454

PSADT
<2.5 months
<0.001
2.138
1.360–3.360

Novel ARATs
Positive

0.001

0.479

0.306–0.748
PET imaging for metastatic castration sensitive prostate cancer (mCSPC) for patients with PSA response after systemic therapy: A multicentric ambispective analysis.
Authors: Beaufils Mathilde , Meynard Lucie , Bernard-Tessier Alice , Brenot-Rossi Isabelle , Guerin Mathilde , Tauty Alban , Seguin Lorene , Salem Naji , Pignot Geraldine , Vicier Cecile , Walz Jochen , Roubaud Guilhem , Elouen Boughalem , Gravis Gwenaelle
Published: February 2025

37

Background:
PET imaging is not recommended for surveillance of mCSPC but it is used by some physicians. Little is known about surveillance for metastatic prostate cancer using PET imaging. The aim of this study was to assess the correlation between PSA response and PET imaging for mCSPC.
Methods:
An ambispective, multicentric, observational study, recorded PET imaging for patient’s treated with a minimum of 6 months of systemic therapy with androgen deprivation therapy (ADT) +/- androgen receptor pathway inhibitor (ARPI) +/- docetaxel for mCSPC with PSA < 0.2 ng/ml, normal CT scan and non progressive disease in bone scan. All of them had baseline evaluation with standard imaging.
Results:
Between August 2022 and September 2024, 57 patients (pts) with mCSPC were included, in 4 centres in France. Baseline characteristics at the time of metastatic disease were: median age of 65 years (range: 45-84), ISUP ≥4 for 63%, median PSA 22.1 ng/ml (1.6-5000ng/ml) with T≥3 in 53%. The majority of pts had low volume disease 56%, with synchronous metastatic disease for 67% and ≥ 4 bone metastases in 44%. Only 5 pts had visceral metastases. Pts were treated, by ADT + ARPI in 81%, ADT + docetaxel in 7% and triplet in 12% of cases. Patients had prostate radiotherapy (RxT) in 39% and RxT to metastatic bone lesion in 19%. The 8 months PSA was <0.2 ng/ml in 89% of pts. PET imaging was choline in 86%, PSMA in 14%. Median time between treatment initiation and PET imaging was 17 months and delay between PSA < 0.2 and PET imaging was 12 months (range: 0-32). A complete response was observed in 46 patients (81%). Non-complete responders (CR) were more frequently high volume disease (66%) and synchronous metastasis (100%), treated by ADT + ARPI alone (77%) or ADT + docetaxel (11%). Non CR were: 1 neuroendocrine progression, 1 lung cancer and 9 partial responders (2/9 progressed later).
Conclusions:
In patients with mCSPC, treated by ADT with ARPI and or docetaxel and with PSA < 0.2 ng/ml, a complete response is observed in 81 % when using PET imaging. The information given by PET imaging could be and additional surrogate measure to PSA response for intensification or de intensification the systemic and local treatment for mCSPC.
Incidence of EMBARK and EAU high-risk biochemical recurrence and prostate cancer mortality: A real-life population-based study.
Authors: Falagario Ugo Giovanni , Pellegrino Francesco , Carrieri Giuseppe , Lantz Anna , Akre Olof , Wiklund Peter
Published: February 2025

372

Background:
The EMBARK trial proved the efficacy of enzalutamide plus leuprolide in patients with prostate cancer (PCa) who have had high-risk biochemical recurrence (BCR). Different criteria are currently used to define high-risk BCR. The aim of this study was to evaluate the incidence of several definitions of High-risk BCR after radical prostatectomy (RP) or radiotherapy (RT) and their association with PCa specific mortality (PCSM).
Methods:
Population-based study including 17,753 men undergoing RP (n=12,010) or RT (n=5743) with curative intent (cT1-3, cM0) and PSA follow-up in Stockholm between 2003 and 2021. Follow-up for all patients was until death, emigration, or end of the study period (December 31, 2021). Primary outcomes were the cumulative incidence of any BCR (RP: PSA≥ 0.2; RT: PSA≥ nadir+2) and high-risk BCR (according to EAU and Embark criteria) estimated using the Kaplan Mayer method and PCSM accounting for competing risk.
Results:
The 10-year cumulative incidences of any BCR, EAU, and Embark high-risk BCR were 25% (95% CI 24, 26), 10% (9, 11), 4% (3, 4) after RP and 20% (19, 22), 10% (9, 11) and 10% (9, 11) after RT. Median time from RP to high-risk BCR was 12.6 (5.8, 25.7) months for EAU criteria and 11.8 (5.1, 22.3) months for Embark criteria. Similarly median time from RT to high-risk BCR was 21.2 (11.3, 45.9) months for EAU criteria and 23.4 (14.3, 38.3) months for Embark criteria.After RP, the 10-year Cumulative incidences of PCSM were 11% (95% CI: 9, 13), 17% (14, 21) and 30% (24, 37) for any BCR, EAU and Embark high-risk BCR, respectively. After RT, the 10-year PCSM cumulative incidences were 39% (35, 44), 50% (45, 56) and 49% (42, 55), respectively.
Conclusions:
Incidence of High-Risk BCR vary according to the definition used and primary treatment. High risk BCR usually happen early after treatment and most patients with any PSA elevation will never experience High-risk BCR during the follow-up. Embark criteria currently represent the more stringent criteria with a very high risk of PCSM.

Pattern of presentations of BCR, and high-risk BCR according to EAU and EMBARK criteria after radical prostatectomy or radiotherapy.

Primary treatment
Radical Prostatectomy
Radiotherapy

PSA> 0.2
N=2501

EAU High Risk BCR
N=1119

EMBARK High Risk BCR
N=386

PSA>Nadir + 2
N=836

EAU High Risk BCR
N=427

EMBARK High Risk BCR
N=456

Time frame, n (%)

0-1 year
660 (26.4%)
535 (47.8%)
199 (51.6%)
117 (14.0%)
117 (27.4%)
96 (21.1%)

1-3 years
757 (30.3%)
392 (35.0%)
139 (36.0%)
297 (35.5%)
171 (40.0%)
229 (50.2%)

3-5 years
463 (18.5%)
111 (9.9%)
29 (7.5%)
198 (23.7%)
79 (18.5%)
109 (23.9%)

5-7 years
286 (11.4%)
48 (4.3%)
10 (2.6%)
85 (10.2%)
23 (5.4%)
16 (3.5%)

>7 years
335 (13.4%)
33 (2.9%)
9 (2.3%)
139 (16.6%)
37 (8.7%)
6 (1.3%)

Time to BCR, n (%)
29.7 (11.3, 59.6)
12.6 (5.8, 25.7)
11.8 (5.1, 22.3)
36.6 (18.6, 62.4)
21.2 (11.3, 45.9)
23.4 (14.3, 38.3)
Racial and ethnic disparities in urinary continence recovery post-prostatectomy.
Authors: Drysch Austin , Driscoll Conor , Murphy Adam B , Kundu Shilajit D. , Victorson David
Published: February 2025

376

Background:
Urinary incontinence is a common complication following prostatectomy, with continence recovery rates varying widely across the literature. While 12-month continence rates are consistently above 90%, disparities in short- and intermediate-term recovery rates exist. This study investigates the differences in overall urinary continence outcomes among Black, non-Black Hispanic, and non-Black non-Hispanic men within 12 months post-surgery.
Methods:
Data were collected from two sources: (1) men recruited in clinic from the Northwestern University Department of Urology as part of the URO-QOL study, an observational study of Quality Of Life (QOL), and (2) cross-sectional, retrospective data from an online health panel maintained by OP4G (Opinions 4 Good, http://op4g.com/). Eligible participants had clinically localized prostate cancer, were 18 years or older, and were able to read and speak English. Urinary continence outcomes were assessed within 12 months post-surgery using the American Urological Association Symptom Score (AUASS), Expanded Prostate Cancer Index Composite-26 (EPIC-26), and Functional Assessment of Cancer Therapy-Bladder (FACT-Bl). One-way ANOVA, as well as Chi-squared tests, were performed to assess differences in functional outcomes across racial and ethnic groups.
Results:
There were 417 patients total, with 57 (14%) Black men, 87 (21%) non-Black Hispanic men, and 273 (65%) non-Black non-Hispanic men.One-way ANOVA demonstrated significant differences in overall AUA Symptom Score (p=0.0166) and EPIC-26 Urinary Symptom Score (p=0.00276), but not FACT-Bl Scores (p=0.253), between Black, non-Black Hispanic, and non-Black non-Hispanic men, with Black men demonstrating highest symptom burden across all three surveys (Table).
Conclusions:
Racial and ethnic disparities in urinary continence recovery following radical prostatectomy are evident, with Black men in particular experiencing worse outcomes compared to Hispanic and non-Black non-Hispanic men. While overall functional recovery improves within 12 months post-surgery, these disparities suggest a need for further investigation into underlying factors influencing these outcomes. Ultimately, targeted pre- and post-operative interventions such as pelvic floor muscle training may help mitigate the racial and ethnic disparities highlighted in this study.

Univariate ANOVA analysis of summed scores of post-treatment urinary symptoms surveys.

Overall
Black
Non-Black Hispanic
Non-Black Non-Hispanic
P-value

AUASS

Sum (mean)
21.40
23.32
22.95
20.48
0.0166*

Category (mean)
2.556
2.737
2.628
2.494
0.0137*

EPIC-26

Sum Urinary Symptom Responses (mean)
19.96
22.78
20.92
19.07
0.00179*

Overall Urinary Symptom Score^ (mean)
50.584
42.644
48.109
53.053
0.00276*

FACT- Bl

Sum (mean)
8.856
9.302
9.076
8.678
0.253

*p<0.05 denotes statistical significance.

^Lower EPIC-26 score represents higher symptom burden.
The impact of pelvic radiotherapy on hematological outcomes in pediatric genitourinary rhabdomyosarcoma.
Authors: Malshy Kamil , Cheng Zijin , Hunt Trevor C , Campbell Timothy , Steidl Matthew , Fairbourn Jason , Li Ashley , Kucherov Victor , Bandari Jathin
Published: February 2025

379

Background:
Hematological toxicities are common with radiation therapy (RT), particularly pelvic RT, which affects nearly 50% of total body hematopoiesis. This study evaluates the impact of pelvic RT on hematological toxicities in pediatric patients with pelvic genitourinary rhabdomyosarcoma (GU-RMS).
Methods:
Following permission, a secondary analysis was conducted on 488 pediatric subjects with intermediate-risk RMS from the ARST0531 (NCT00354835) trial. This trial compared Vincristine, Dactinomycin, and Cyclophosphamide (VAC) to VAC alternating with Vincristine and Irinotecan (VI). Both arms received RT starting in week 4. Of these, 65 patients had pelvic GU-RMS (bladder/prostate = 60 [92.3%]; female-organ = 2 [3.1%]; paratesticular = 3 [4.6%]) and received pelvic RT, while 423 received non-pelvic RT. Multivariable logistic regression models assessed hematological toxicities (anemia, leukopenia, neutropenia, thrombocytopenia, lymphopenia) during weeks 1–43, adjusting for age, race, tumor size, and chemotherapy. Primary outcomes included any hematological toxicity, and secondary outcomes focused on febrile neutropenia (FN), infectious complications (IC), and the timing of toxicity at T1 (weeks 1–15), T2 (weeks 16–30), and T3 (weeks 31–43).
Results:
Subjects with GU-RMS receiving pelvic RT did not have a significantly higher risk of cytopenias compared to non-GU RMS patients. Neutropenia affected 79.4% of patients, with no significant difference between GU (73.8%) and non-GU (80.4%) (OR 0.64, p=0.16). Thrombocytopenia was significantly more common in GU-RMS patients during the first 15 weeks (OR 2.79, p=0.01). FN and IC were comparable across groups.
Conclusions:
Hematological toxicities were similar in pediatric GU and non-GU RMS patients. Pelvic RT was linked to an early rise in thrombocytopenia, though the difference diminished over time. Understanding these toxicities is key to improving management of pediatric RMS patients.

Patient characteristics and hematological toxicities outcomes: pelvic GU vs. non-GU primary.

Parameter
Overall Cohort, N (%)N = 488
GU, N (%)N= 65 (14.51)
Non-GU, N (%)N = 383 (85.49)
p-value

< 10 y.o.
306 (68.30)
56 (86.15)
250 (65.27)
0.001

Male
241 (53.79)
48 (73.85)
193 (50.39)
<0.001

White Race
319 (71.21)
48 (73.85)
271 (70.76)
0.487

Cytopenia

OR (95% CI,
p
)

Anemia
159 (35.5)
24 (36.9)
135 (35.2)
0.96(0.54-1.70, 0.89)

Thrombocytopenia
131(29.2)
22 (33.8)
109 (28.4)
1.49 (0.81-2.73, 0.20)

Leukopenia
196 (43.75)
26 (40)
170 (44.4)
0.73 (0.42-1.27, 0.27)

Neutropenia
356 (79.4)
48 (73.8)
308 (80.4)
0.64 (0.34-1.19, 0.16)

Lymphopenia
105 (23.4)
15 (23.1)
90 (23.5)
0.85 (0.45-1.61, 0.61)

GU – Genitourinary; OR – Odds Ratios.
An open-label phase 1, window-of-opportunity study of ultrasound-guided long acting periprostatic neuraxial block with ethanol in patients with high-risk prostate cancer.
Authors: Zahalka Ali , Haines III George , Margulis Vitaly , Tewari Ashutosh K.
Published: February 2025

391

Background:
Patients (pts) with high-risk prostate cancer (PCa) have an elevated risk of disease recurrence/progression after definitive therapy. These pts also exhibit increased levels of adrenergic nerve density on PCa histology. Pre-clinical evidence from murine models of PCa suggest that PCaNeurolysis of periprostatic adrenergic nerves inhibits cancer progression and metastasis by inhibiting angiogenesis, altering cancer metabolism, and inhibiting cell migration (PMC5783182). Pure Ethanol (>99%) injection for neurolysis is FDA-approved in chronic cancer pain and may have a survival benefit in late-stage cancers (PMC1242819). Ultrasound-guided (US) short-acting periprostatic neuraxial block with lidocaine is commonplace in urologic practice. Thus, PCaNeurolysis with ethanol may have both a protective effect in high risk PCa and be feasibly implemented.
Methods:
Pts with NCCN high risk PCa who were interested and eligible for surgery, and who did not have any prior PCa treatments received in-office US guided PCaNeurolysis with either 3mL or 5mL of pure ethanol 4 to 6 weeks prior to radical prostatectomy (surgery was not delayed for trial participation). Dose escalation was determined by keyboard design with 6 pts per group (dose limiting toxicity [DLT] period = 6 weeks; DLT ³ Grade 3 events).
Results:
Dose escalation: 12 pts, median age 68, were treated at 2 dose levels: 3/5mL (n=6/6) with no DLTs in either group, suggesting 5mL was maximal tolerated dose to use in future studies. Additionally, no off-target effects including no decrease in erectile function (Sexual Health Inventory for Men score), no increase in urinary symptoms (International Prostate Symptom Score), and no added difficulty (eg. Destruction of tissue planes) during prostatectomy were observed in any pts. 7 pts underwent prostatectomy (43% cT3a) and were included in secondary analysis: median decrease in adrenergic density on final pathology (35%), ≥pT3a (0%), 18month biochemical recurrence (14%).
Conclusions:
PCaNeurolysis with ethanol was well tolerated, and 5mL was the maximum tolerated dose to use in future studies. Histologically significant decrease in adrenergic nerve density was observed suggesting the intervention acts upon its intended target, and the intervention may have antitumor activity (43% pre-injection cT3a, but 0% ≥pT3a on final pathology after injection). These Phase 1 results encourage continued investigation of PCaNeurolysis in high risk PCa pts.
Defining subgroups of patients with intermediate risk prostate cancer for whom active surveillance is safe.
Authors: Del Castillo Ruben , Vesprini Danny , Liu Stanley K , Leong Hon , Beera Mona , Sadiq Zeeba , Zhang Liying , Mamedov Alexandre , Kulasingham-Poon Meghan , Klotz Laurence , Loblaw Andrew
Published: February 2025

393

Background:
A number of guideline groups recommend active surveillance (AS) for patients with low risk prostate cancer as well as selected patients with intermediate-risk prostate cancer (IRPC) – these groups are not well defined. Our group has previously shown that some patients with IRPC have high rates of progression to advanced disease. The goal of this study was to determine a subset of patients with IRPC where AS is safe.
Methods:
This single-institution, phase II study enrolled men with low-risk and selected IRPC patients since 1995. Patients were followed with PSA every 3-6 months, DRE every 6 months with repeat systematic biopsies at 1 year and every 3 years. Since 2013, MRI staging was done every 2 years with targeted and systematic biopsies done for new or growing lesions. Patients were followed until death or withdrawn consent. Time to treatment, metastasis-free survival (MFS), cause-specific survival (CSS) and overall survival were calculated from date of registration biopsy.
Results:
1409 men were analyzed with a median follow-up of 11.0 years (range 1.2 – 26.4 years). Median age and PSA at registration biopsy were 67 years and 5.03 ng/ml. 86.4%, 11.8% and 1.7% had GG1, GG2 and GG3 disease. 72.9%, 5.8%, 7.3% and 13.6% had low, GG1 favourable IRPC (FIR), GG2 FIR and unfavourable risk ds (UIR). 996 men had at least one repeat biopsy, 768 reclassified, 604 underwent treatment, 166 had biochemical failure, 64 developed metastases and 41 died of prostate cancer. 10 year MFS was 97.4%. Absolute percentage pattern 4/5 (APP4) at baseline had a sensitivity of 36%, specificity of 86% and AUC of 64% with an optimal cutpoint of >0.30 for predicting MFS. Multivariable analysis (MVA) revealed APP4 (HR 2.86) at baseline and at repeat biopsy (vs baseline) of high risk vs UIR (HR 5.61) and high risk vs GG2 FIR (HR 10.4) were independent predictors of MFS. 10 year CSS was 98.5%. MVA revealed APP4 (>0.7, AUC 67%; HR 3.13) and high risk vs UIR (HR 34.4) were independent predictors of CSS.
Conclusions:
Patients with GG1 prostate cancer and those with GG2 FIR and APP4 < 0.30 appear to have very low risk of metastases and prostate cancer death and are suitable for active surveillance.
Chimeric RNA landscape in the Chinese population and the role of
SFT2D2-TBX19
in prostate cancer progression.
Authors: Wang Qiong
Published: February 2025

406

Background:
Specific gene fusions and their fusion products (chimeric transcripts and proteins) have served as ideal diagnostic markers and therapeutic targets for cancer. However, few systematic studies for chimeric transcriptome have been conducted in prostate cancer (PCa), and none in the Chinese populations.
Methods:
We analyzed raw RNA-seq data from PCa patients in the Chinese Prostate Cancer Genome Epigenome Atlas (CPGEA) to predict chimeric RNAs using the Eriscript. Fluorescence-activated cell sorting (FACS) was employed to isolate tumor cells, cancer-associated fibroblasts (CAFs), tumor-associated macrophages (TAMs), and T cells from fresh clinical specimens. Cellular functional assays, western blotting, FISH, electron microscopy, RNA pull-down, and immunofluorescence were employed to elucidate the underlying mechanisms by which the chimeric SFT2D2-TBX19 regulates prostate cancer progression.
Results:
Over 100,000 chimeric RNAs have been predicted in CPGEA. After several rounds of screening, we identified 301 of them with differential expression between cancerous and adjacent normal tissues, and 101 out of them were validated in clinical samples. About 20% showed prognosis correlation, indicating their potential biomarker values. Further experiments found differential expression of those chimeras among cancer epithelial cells, CAFs, TAMs, and T cells. We further examined the effect of these chimeric RNAs, and found examples of chimeric RNAs directly regulates the growth and motility of tumor cells, and regulate communications between tumor cells and their microenvironment, which jointly facilitate tumor progression. An important chimeric RNA,
SFT2D2-TBX19
, was identified as encoding the TBX19-202 protein. Both TBX19-202 and its parental TBX19, which share homologous amino acid sequences, enhance prostate cancer cell proliferation, migration and invasion. Additionally,
SFT2D2-TBX19
also can work as a lncRNA which could interact with the ATP synthase F1 subunit ATP5F1A, increasing ATP5F1A phosphorylation, which stabilizes the interaction between ATP5F1A and ATP5F1B. The region spanning 1801-2400bp of
SFT2D2-TBX19
and the intermediate structural domain of ATP5F1A are crucial functional areas. This stabilization of ATP5F1A and ATP5F1B enhances mitochondrial ATP synthase activity and ATP production, thus maintaining prostate cancer cell proliferation.
Conclusions:
These findings established the atlas of chimeric transcriptome in PCa from the Chinese populations, and provided a large list of validated chimeric RNAs that have the potentials of becoming novel biomarkers and/or treatment targets. Our research provides comprehensive evidence that the
SFT2D2-TBX19
promotes prostate cancer progression by encoding the TBX19-202 protein and stabilizing mitochondrial ATP synthase through ATP5F1A phosphorylation.
The role of conventional imaging and piflufolastat F18 in newly diagnosed and recurrent prostate cancer patients: Preliminary observations from the PYLARIFY Registry.
Authors: Shore Neal D. , O'Donnell Lorraine , Wilson Basil , Dave Shashank Subhash , Kashyap Arpit , Lazarou Nicholas
Published: February 2025

41

Background:
Next generation imaging modalities for the diagnosis and characterization of prostate cancer have seen increased utilization in the past several years. PSMA-PET imaging has seen particular promise as a more accurate modality compared to conventional (CT, skeletal scintigraphy and PET) imaging. Use of PSMA imaging can significantly improve how prostate cancer is staged and thus enhance the clinicians’ confidence in therapeutic decision making.
Methods:
The PYLARIFY Registry (NCT 05712473), conducted under SoNaR, a Specialty Networks Registry, is a US-based multi-center prospective 5 year observational study following patients receiving standard of care piflufolastat F18 imaging as part of their prostate cancer management. The registry includes newly diagnosed patients who have not yet initiated any treatment (Cohort 1) and patients with biochemical recurrence (Cohort 2). Demographics, all baseline imaging procedures and the frequency of each type of imaging for the first 100 enrolled patients were analyzed. We also explored time-to-PSMA for newly diagnosed patients who received conventional imaging as part of their staging assessment. The clinician confidence ratings that the piflufolastat F18 imaging had on treatment decision making were also evaluated.
Results:
The first 100 patients had a mean age of 71.0 (SD 9.1) and 80% had a Gleason Grade group of 2 or higher. At least 1 conventional imaging procedure prior to the piflufolastat F18 PET scan was performed on 10% of patients in Cohort 1 and 77% in Cohort 2. For Cohort 1 patients, piflufolastat F18 scans were preceded by a total of 4 imaging procedures, with an average of 1 conventional imaging procedure per patient prior to their piflufolastat F18 scan. Cohort 2 patients had a total of 95 imaging procedures with an average of 1.58 conventional imaging procedures per patient prior to their piflufolastat F18 scan. The 3 most utilized conventional imaging modalities in both cohorts of patients that received conventional imaging prior to piflufolastat F18 scans were CT (80%), and skeletal scintigraphy (72%) and PET (26%). The median difference in diagnostic journey length between Cohort 1 newly diagnosed patients having conventional imaging and those having only piflufolastat F18 was 28 additional days. Across both cohorts, clinicians rated improvement in treatment planning confidence following 96% of piflufolastat F18 scans.
Conclusions:
Piflufolastat F18 provides a high degree of confidence for prostate cancer patient management. A growing number of patients are being managed with piflufolastat F18 scans only. Many patients however still undergo lengthy and resource-intensive conventional imaging procedures prior to their piflufolastat F18 scan.
Characterizing the activity of inflammasome genes and their association with oncological outcomes in prostate cancer.
Authors: Ghoreifi Alireza , Alshalalfa Mohammed , Davicioni Elai , Hao Yangyang , Spratt Daniel Eidelberg , Karnes R. Jeffrey , Purves J. Todd , Hughes Jr. Francis M. , Moul Judd W. , Abern Michael R
Published: February 2025

410

Background:
Inflammasomes are multiprotein complexes that regulate inflammation-associated signaling pathways. Although inflammation plays a crucial role in cancer cell proliferation, the specific role of inflammasomes in prostate cancer (PCa) remains underexplored. This study aims to elucidate the expression of inflammasome-related genes in PCa and assess their association with clinical outcomes.
Methods:
De-identified transcriptome data from a cohort of 52,266 radical prostatectomy (RP) samples tested (2016-2024) with the Decipher prostate genomic classifier (Veracyte, San Diego, CA) were retrieved from the GRID registry (NCT02609269). Expression analysis focused on 33 genes involved in inflammatory pathways. Outcomes analysis was conducted on a retrospective cohort of 855 patients treated with RP (META855), using Cox regression analysis, adjusting for baseline pathological characteristics.
Results:
Analysis of baseline gene expression in the GRID RP cohort revealed that most genes exhibit low baseline expression, whereas HSP90AB1, APP, TXN, and TXNIP demonstrate strong expression signals. Higher expression of most genes was associated with higher rate of Gleason grade group 4 or 5 in the GRID RP cohort. On survival analysis of the META855 cohort, higher expression (top 25%) of AIM2 and HSP90AB1 were associated with worse metastasis-free survival (p<0.05 for both). Conversely, both high and low expression levels of NLRP3 were associated with better metastasis-free survival outcomes following RP compared to average expression (p<0.05). On multivariable Cox regression analysis, adjusting for grade group, seminal vesicle involvement, lymph node involvement, and margin status, higher expression of AIM1 (HR 1.75) and HSP90AB1 (HR 1.60) were significantly associated with shorter time to metastasis following RP (p<0.05 for both).
Conclusions:
There is a molecular heterogeneity within pro-inflammatory genes among patients with PCa.Our findings showed thathigher expression of HSP90AB1 is linked to poorer oncological outcomes, whereas both high and low expression levels of NLRP3 are associated with better outcomes following RP.Further refinement is required to build a robust signature, along with external validation of these findings in other cohorts.
Decipher genomic classifier (DGC) of early prostate cancer (EPC), and underlying transcriptomic profile (TP): American (Am) versus non-American (NA).
Authors: Keizman Daniel , Davicioni Elai , Peer Avivit , Sarid David , Rouvinov Keren , Sella Avishay , Dresler Hadas , Manaster Yoav
Published: February 2025

414

Background:
Data on DGC in EPC, come predominantly from US patients (pts), revealing significant reclassification of NCCN risk Despite its global use, data among NA is scant. We aimed to analyze DGC results and TP among NA versus (vs) Am with EPC
Methods:
From the DGC database (Decipher Biosciences Inc), we identified and analyzed the results (risk and TP) of Israeli (Is) vs matched Am pts with EPC. Matching was according to common NCCN clinicopathologic features (T and N stage, Gleason grade, number of adverse pathologic features).
Results:
Among Is pts, 692 (median age, ma, 69) had a biopsy (bx) DGC, and 115 (ma 67) a post prostatectomy (PP) DGC. Their median DGC in bx was 0.47, and PP 0.78. DGC risk was 45% low, 24% intermediate, 31% high, in bx, and 13% low, 16% intermediate, 71% high, PP. Bx DGC led to reclassification of risk in 33% of pts with clinical NCCN low-favorable intermediate risk, and 48% of pts with clinical NCCN unfavorable intermediate-high risk. Among matched Am, 103,108 (ma 68) had a bx DGC, and 40,906 (ma 65) a PP DGC. Am median DGC was 0.43 in bx, and 0.65 PP. Am DGC risk was 52% low, 20% intermediate, 28% high, in bx, and 28% low, 17% intermediate, 55% high, PP. While NCCN risk grouping was similar between Is vs matched Am (p=1.0), median DGC risk was significantly higher among Is (p<0.001), and the distribution of DGC risk groups significantly different (p=0.004 for bx, p<0.001 PP). A correlative TP analysis revealed greater overall differences of Isi vs matched Am. Significant (p<0.001) differences in bx DGC, included AR status (intact vs deficient), prostate subtype classifier (PSC, luminal differentiated, luminal proliferating, basal immune, basal neuroendocrine), PAM50 (Luminal A, Luminal B, Basal), RSI (1), Cell cycle progression (2), activated CD8, T regulatory cells, angiogenesis (Uhlik), Myeloid derived suppressor cells, Interferon response alpha hallmark, and immune 190. Significant (p<0.001) differences in PP DGC, included AR activity, p53 mutation, PSC, PAM50, SC/NE (adenocarcinoma, neuroendocrine carcinoma (3), RSI, activated CD4 and CD8, T regulatory cells, angiogenesis (Uhlik), tertiary lymphoid structure, PDL2 signature, Myeloid derived suppressor cells, and Interferon response alpha hallmark.
Conclusions:
In early prostate cancer, as previously reported among American pts, DGC may be an important tool for accurate patients risk assessment, leading to NCCN risk reclassification in a significant proportion, Furthermore, the present study preliminary results suggest that geographic variation DGC may exist, and correlate with differences in transcriptomic profile. 1. Torres-Roca 2009. 2. Cuzick 2011. 3. Beltran 2016.
Assessment of the proficiency of ChatGPT-4o in an image-based robot-assisted radical prostatectomy scenario.
Authors: Li Jiakun , Zhao Jing , Wang Zeqi , Tong Le , Shen Bairong , Wei Qiang
Published: February 2025

423

Background:
Surgery is a process that heavily relies on complex visual information. Many AI-based surgical teaching and assistance applications have emerged. However, the application of the newly released ChatGPT-4o in surgical contexts remains unexplored. This study aims to investigate the ability of ChatGPT-4o in analyzing and recognizing anatomical structures, surgical procedures, and operational precautions based on image information in a surgical context. Utilizing screenshots from robot-assisted radical prostatectomy videos sourced from the internet.
Methods:
We developed a test comprising 77 images and 65 questions, with a total score of 100 points. The test includes sections on anatomical structures, surgical procedures, and operational precautions. We sequentially input the questions into the ChatGPT-4o model and employed strategies to enhance its performance during the test. A passing score was set at 60 points or above, and an excellent score at 80 points or above.
Results:
ChatGPT-4o achieved a score of 68, surpassing the passing threshold. The accuracy for non-image questions was higher than for image-based questions (85.71% vs. 58.46%, χ² = 7.78, p = 0.005), and questions with fewer images had a higher accuracy than those with multiple images (71.11% vs. 30.00%, p < 0.001). Furthermore, we found ChatGPT-4o performed differently in recognizing different structures, with the highest accuracy for questions involving muscle and fascia (100%) and the lowest for those involving nerve and vessel structures (33.33%).
Conclusions:
ChatGPT demonstrated commendable abilities in image recognition and problem analysis in surgical contexts. We hope that the results of this study will contribute to future applications of ChatGPT in AI-assisted surgical teaching and assistance.
RadOnc-GPT (gpt-4o) versus human data extraction for prostate cancer clinical research.
Authors: Namazi Mohammad Javad , Borras Osorio Mariana , Holmes Jason M , Routman David M. , Ebner Daniel , Wang Peilong , Liu Wei , Waddle Mark Raymond
Published: February 2025

425

Background:
Prostate cancer (PC) ranks among the most prevalent cancers in men, with incidence rising due to factors like aging populations and enhanced screening techniques. Effective data extraction from clinical records is crucial for advancing research and improving patient care; however, traditional manual methods can be time-consuming and susceptible to mistakes. This study seeks to evaluate RadOnc-GPT against human annotation for extracting essential clinical information from prostate cancer clinical records.
Methods:
RadOnc-GPT is a retrieval augmented generation (RAG)-based chatbot with access to a variety of patient data including treatment details, radiology reports, and clinical notes. RadOnc-GPT uses Open AI’s gpt-4o model. Patients who received curative intent radiotherapy as initial treatment for PC in our institution between 2014 and 2023 were randomly selected for evaluation. Relevant Clinical factors were extracted by a human expert annotator on our on-site RedCap database. The extraction of the same variables was performed using RadOnc-GPT. A comparison between the ground truth (human annotation) and RadOnc-GPT, to evaluate the performance of the AI system, was carried out including accuracy, recall and F1 score.
Results:
A total of 382 PC patients were included in the cohort for data extraction. The clinical variables extracted were the treatment intent, NCCN risk category, T and N stage, Gleason score, radiation volume, and Androgen Deprivation therapy (ADT) use. The overall performance of RadOnc-GPT was excellent, with the highest accuracy achieved for treatment intent (99.7%), Gleason score (98.4%), and Treatment Volume (90.1-99.5%).
Conclusions:
RadOnc-GPT performed excellent at extracting relevant clinical details from the electronic medical record and radiation oncology information systems with dramatic reduction in time and cost compared with manual review. LLMs could be highly useful for large-scale data extraction in PC research, offering a promising solution for automating the accurate data extraction process.

Correct (n)
Total (n)
Accuracy
Recall
F1 score

RT with curative intent
381
382
99.7
99.9
99.9

Prostate Cancer Risk Category
345
382
90.3
90.4
95.1

Primary tumor staging (T) at diagnosis
368
382
96.3
96.3
97.9

Regional nodal status (N) at diagnosis
352
382
92.1
92.2
95.9

Gleason Score Primary Secondary Total
376372376
382382382
98.497.498.4
98.597.498.5
99.298.799.2

Treated Areas Prostate Pelvic Nodes Para-Aortic Nodes Distant Site
380344378372
382382382382
99.590.19997.4
99.490.199.197.4
99.79599.598.7

ADT Use with RT
365
382
95.5
95.7
97.8