European urology oncology最新文献

Background and objective: Partners of prostate cancer (PCa) patients may play an important role in the care process. Therefore, Europa Uomo initiated the Europa Uomo Prostate cancer Partners in Europe Research (EU-ProPER) study to study the partner's perspective. The study aims to assess the quality of life of partners of PCa patients, and the impact of a PCa diagnosis and its subsequent treatment on the partner.

Methods: Based on information of the PCa-partner program of the annual Dutch PCa Foundation meetings and expert input, a partner survey was developed. The survey includes themes on communication, relationship, social functioning, and general health (12-item Short Form Health Survey v2) of the partner, and the impact of urinary incontinence (UI) and sexual dysfunction (SD). The EU-ProPER survey was pretested in 16 partners and was available online in 17 languages.

Key findings and limitations: Between October 9 and Dec 31, 2023, 1135 partners completed the survey. The median age at completion was 68 yr (interquartile range [IQR] 62-73); it was 61 yr (IQR 55-67) at the time of diagnosis. Of the partners, 89% can openly talk about PCa to their partner and 73% feels that communication has not gotten worsen since the PCa diagnosis. Communication about UI and SD is more private. Regarding communication with health care professionals, PCa patients and partners are more often informed about UI (66%) than about intimacy/SD (20-24%). Most partners feel, however, that information about sexuality should be provided upfront to both the PCa patient and the partner (87%).

Conclusions and clinical implications: Europa Uomo has engaged an unprecedented number of partners of PCa patients. Communication is an important topic in which intimate topics such as UI and SD are more private. Communication with health care professionals about intimacy/sexuality is currently suboptimal and needs to be improved.

Background and objective: The surgical plan in robotic-assisted radical prostatectomy (RARP) aims to achieve optimal perioperative, oncological, and functional outcomes by recommending the extent of resection and use of function sparing techniques. However, there is a lack in high-level evidence on the optimal process to define the plan preoperatively. We therefore undertook a consensus exercise to develop the best practice statement to supplement evidence-based guidelines.

Methods: A consensus exercise was undertaken using a modified RAND/University of California Los Angeles approach. Consensus was a priori defined as ≥75% agreement/disagreement. A total of 101 statements were developed by the steering group based on a previously published systematic review and were reviewed in three rounds by 14 panellists.

Key findings and limitations: Overall, 73 statements reached consensus and 34 reached consensus across six domains. The process concluded that a preoperative surgical plan is essential prior to undertaking any RARP and will facilitate the optimal execution of surgery, as it provides the best available information to the surgeon to refine the technique and potentially improve oncological, functional, and perioperative outcomes.

Conclusions and clinical implications: The consensus statements draw out the best practices in the surgical planning process and can assist surgeons in standardising their approach. Gaps (areas of nonconsensus) have also been identified that can direct future work.

Background and objective: The European Randomized Study of Screening for Prostate Cancer (ERSPC) has shown that prostate-specific antigen (PSA)-based screening reduces prostate cancer (PCa)-specific mortality (PCSM). However, the mediating role of a stage shift and curative treatment in the causal pathway from screening to reduced PCSM has not been elucidated.

Methods: In the ERSPC trial, men were randomly allocated to either a screening arm, with regular PSA measurements, or a control arm. During 16-yr follow-up, 8046 men from Finland, 3701 from the Netherlands, and 1382 from Sweden were diagnosed with PCa and were aged 55-69 yr at the time of randomization. A directed acyclic graph was used to define the impact of screening on the PCa-specific restricted mean survival time (RMST) after randomization, mediated by risk group and treatment at diagnosis.

Key findings and limitations: The absolute increase in RMST over 16 yr for men in the screening arm versus the control arm was 0.13 yr (95% confidence interval [CI] 0.05-0.22) in Finland, 0.48 yr (95% CI 0.24-0.62) in the Netherlands, and 0.44 yr (95% CI 0.22-0.68) in Sweden. This effect was mainly attributable to risk group at diagnosis, and not through treatment at the time of diagnosis. A limitation of the study is that we only included the three largest ERSPC centers.

Conclusions and clinical implication: The reduced PCSM achieved by early PCa detection via PSA-based screening is caused by more favorable prognostic features and subsequent improved treatment outcomes. Our findings confirm that the observed results are a causal effect of screening.

Background and objective: Management of oligometastatic renal cell carcinoma (omRCC) remains undefined, especially in favorable- and intermediate-risk patients, in whom treatment de-escalation may reduce toxicity and preserve quality of life. This study aims to evaluate sequential stereotactic ablative radiotherapy (SAbR) as first-line therapy in systemic therapy-naïve patients with omRCC.

Methods: A prospective, single-arm, phase 2b trial enrolled systemic therapy-naïve renal cell carcinoma (RCC) patients with three or fewer extracranial metastases, all treated with SAbR to all sites. The primary endpoint was to measure the percentage of patients with time to systemic therapy (TTST) >1 yr. Modified progression-free survival (mPFS) was defined as the earliest time of developing one of the following predefined criteria for local therapy escalation: more than three new metastases, more than six total metastases, local failure at an SAbR-treated site, brain metastases, or lesions not amenable to SAbR. The secondary endpoints included mPFS, progression-free survival on subsequent therapy, overall survival (OS), cancer-specific survival (CSS), local control, toxicity, and health-related quality of life (HRQoL).

Key findings and limitations: Twenty-three patients received SAbR to 69 lesions. The median follow-up was 45 mo. TTST >1 yr was achieved in 91% of patients; the median TTST was 55.6 mo. The median mPFS was 40 mo. Local control was 100%. The 3-yr OS and CSS rates were 68.7% and 87.0%, respectively. One patient developed grade 3 colitis possibly related to SAbR, progressing to grade 5 following immunotherapy. HRQoL remained stable. Single-arm design limits causal inference and generalizability.

Conclusions and clinical implications: Sequential SAbR achieved durable disease control and was not associated with significant changes in patient-reported quality of life, supporting a survivorship-centered, de-escalation strategy that avoids early systemic therapy in selected omRCC patients.

Background and objective: The role of ultrahypofractionated (UH) whole-pelvis radiotherapy (WPRT) as an alternative to conventionally fractionated (CF) WPRT is not well defined.

Methods: HOPE is a phase 2, multi-institutional, unblinded, randomized clinical trial designed to compare toxicity and patient-reported outcomes between UH-WPRT and CF-WPRT using the Expanded Prostate Cancer Index Composite (EPIC-50) questionnaire at 1 yr after treatment. Eighty patients with unfavorable intermediate-risk, high-risk, or very high-risk disease for whom high-dose-rate prostate brachytherapy was planned were randomly assigned 1:1 to either CF-WPRT or UH-WPRT.

Key findings and limitations: Baseline clinical characteristics were similar for the CF-WPRT (39 patients) and UH-WPRT (41 patients) arms. All patients received treatment according to their randomization allocation. Median follow-up was 3.34 yr. At 1 yr after radiotherapy, the mean (± standard deviation) EPIC bowel function score was noninferior between the CF-WPRT and UH-WPRT arms (88.4 ± 12.1 vs 90.6 ± 11.1; p = 0.0016 for noninferiority). Similarly, the mean EPIC bowel total score (86.7 ± 14.2 vs 89.0 ± 12.3; p = 0.24) and bother score (85.0 ± 18.0 vs 87.4 ± 16.3; p = 0.28) did not significantly differ between the arms. No significant differences in EPIC urinary subdomains at 1 yr were observed between the arms. No late (>6 wk) grade 3-5 genitourinary or gastrointestinal toxicities were reported in the CF-WPRT arm, while one patient in the UH-WPRT arm experienced grade 3 genitourinary toxicity. The data are not yet mature enough for evaluation of oncological endpoints.

Conclusions and clinical implications: Results from the HOPE trial demonstrate that UH-WPRT is as well tolerated as CF-WPRT when combined with a high-dose-rate brachytherapy boost to the prostate.

Background and objective: Androgen-deprivation therapy survival benefits after radical prostatectomy (RP) in nonmetastatic high-risk prostate cancer (PCa) patients with an undetectable prostate-specific antigen (PSA) level are unclear. The AFU-GETUG-20 study assessed the benefit of leuprorelin immediately after RP in this population.

Methods: This open-label, randomized, phase 3 trial is conducted at 37 French centers. Participants undergoing RP for nonmetastatic PCa were aged ≥18 yr, with a postoperative Gleason score of ≥7 and PSA <0.1 ng/ml. Participants were randomly assigned (1:1) to the observation or leuprorelin (45 mg subcutaneous Q6M, 24 mo) arm. The primary endpoint was metastasis-free survival in the intent-to-treat population (n = 322). The secondary objectives PSA and testosterone level evolution, PCa-specific survival, overall survival, safety, and quality of life.

Key findings and limitations: From 2011 to 2017, 325 patients were randomized to the observation (n = 163) or leuprorelin (n = 162) arm. The 10-yr risk of metastasis occurrence was similar between arms (hazard ratio [HR] 0.63 [95% confidence interval {CI} 0.30-1.30]; p = 0.204) with no differences in PSA rise-free survival (HR 0.74 [95% CI 0.47-1.16]; p = 0.187), overall survival (HR 1.24 [95% CI 0.56-2.76]; p = 0.596), or PCa-specific survival (HR 0.57 [95% CI 0.10-3.17]; p = 0.512). Leuprorelin-treated patients had lower testosterone level after surgery (p < 0.001), shorter time to global health degradation (p = 0.0019), fatigue (p < 0.001), pain (p < 0.001), and additional adverse events, mainly hot flashes (83.6% vs 6.2%), pain (57.2% vs. 17.1%), fatigue (45.4% vs 16.3%), and psychiatric disorders (25.0% vs 2.3%). Insufficient enrollment affected the trial power but permitted pertinent comparison.

Conclusions and clinical implications: Leuprorelin treatment immediately after RP in high-risk nonmetastatic PCa patients with an undetectable PSA level does not improve survival, but increases adverse events, leading to poorer quality of life compared with observation.