Protocol of a randomised, controlled trial comparing immediate curative therapy with conservative treatment in men aged ≥75 years with non-metastatic high-risk prostate cancer (SPCG 19/GRand-P).

BACKGROUND: Older men (aged ≥75 years) with high risk, non-metastatic prostate cancer (PCa) are increasingly treated with curative therapy (surgery or radiotherapy). However, it is unclear if curative therapy prolongs life and improves health-related quality of life (HRQoL) in this age group compared to conservative therapy, which has evolved considerably during the last decade. STUDY DESIGN: The Scandinavian Prostate Cancer Group (SPCG) 19/Norwegian Get-Randomized Research Group-Prostate (GRand-P) is a randomised, two-armed, controlled, multicentre, phase III trial carried out at study centres in Norway, Denmark, Finland, and Sweden. ENDPOINTS: The primary endpoints are overall survival and HRQoL (burden of disease scale, European Organisation for the Research and Treatment of Cancer [EORTC] Elderly Cancer patients). Secondary endpoints are PCa-specific survival, metastasis-free survival, role-functioning scale (EORTC quality of life questionnaire 30-item core), urinary irritative/obstructive scale (26-item Expanded Prostate Cancer Index Composite [EPIC-26]), bowel scale (EPIC-26), intervention-free survival, PCa morbidity, use of secondary and tertiary systemic therapies, mean quality-adjusted life-years (QALYs), and mean total healthcare costs. PATIENTS AND METHODS: A total of 980 men (aged ≥75 years) with non-metastatic, high-risk PCa will initially be screened with Geriatric 8 (G8) health status screening tool and Mini-COG© brief cognitive test. Participants identified by G8 as 'fit' or 'frail' will be randomised (ratio 1:1) to either immediate curative therapy (radiotherapy or prostatectomy) or conservative therapy (endocrine therapy or observation). Participants who are unable or unwilling to participate in randomisation will be enrolled in a separate observation group. Randomised patients will be followed for 10 years. TRIAL REGISTRATION: Ethics approval has been granted in Norway (457593), Denmark (H-22051998), Finland (R23043) and Sweden (Dnr 2023-05296-01). The trial is registered on Clinicaltrials.org (NCT05448547).

The association between age and long-term quality of life after curative treatment for prostate cancer: a cross-sectional study.

OBJECTIVE: We aimed to investigate the associations between age at radical prostate cancer treatment and long-term global quality of life (QoL), physical function (PF), and treatment-related side effects. MATERIAL AND METHODS: This single-center, cross-sectional study included men treated for localized prostate cancer with robotic-assisted radical prostatectomy (RARP) or external beam radiotherapy (EBRT) in 2014-2018. Global QoL and PF were assessed by the European Organisation of Research and Treatment in Cancer Quality of life Questionnaire-C30 (QLQ-C30), side effects by the Expanded Prostate Cancer Index Composite (EPIC-26). Adjusted linear regression models were estimated to assess associations between age (continuous variable) at treatment and outcomes. QLQ-C30 scores were compared to normative data after dividing the cohort in two groups, <70 years and ≥70 years at treatment. RESULTS: Of 654 men included, 516 (79%) had undergone RARP, and 138 (21%) had undergone EBRT combined with androgen deprivation therapy for 93%. Mean time since treatment was 57 months. Median age at treatment was 68 (min-max 44-84) years. We found no statistically significant independent association between age at treatment and global QoL, PF or side effects, except for sexual function (regression coefficient [RC] -0.77; p < 0.001) and hormonal/vitality (RC 0.30; p = 0.006) function. Mean QLQ-C30 scores were slightly poorer than age-adjusted normative scores, for men <70 years (n = 411) as well as for men ≥70 years (n = 243) at treatment, but the differences were not beyond clinical significance. CONCLUSIONS: In this cohort of prostate cancer survivors, age at treatment had little impact on long-term QoL and function. Due to the cross-sectional design, short term impact or variation over time cannot be ruled out.

Predictors of upgrading from low-grade cancer at prostatectomy in men with biparametric magnetic resonance imaging.

Introduction: Prostate-specific antigen (PSA) density has previously been identified as a predictor of histological upgrading at radical prostatectomy, but how information from pre-treatment biparametric magnetic resonance imaging (bpMRI) contributes needs further clarification. The objective of this register-based study was to identify predictors of upgrading at prostatectomy in men with Grade group (GG) 1 and pre-treatment bpMRI. Material and methods: This single-center study included men with GG 1 cancer on prediagnostic biopsy, who underwent bpMRI and robotic-assisted radical prostatectomy (RARP) between March 2014 and September 2019. We estimated logistic regression models to explore predictors for upgrading. The explored potential predictors were age, PSA density, tumor stage and Prostate Imaging Reporting and Data System (PI-RADS) score (dichotomised 1-3 versus 4-5). Results: Upgrading was observed in 56% (73/130) of the men. PSA density was the only significant predictor for upgrading (unadjusted OR = 1.7, 95% CI 1.2; 2.4 adjusted OR = 1.7, 95% CI 1.2; 2.5). The probability of upgrading was lower for men with a PIRADS 1-3 than for PIRADS 4-5, but the difference was not statistically significant (adjusted OR 0.4, 95% CI 0.2; 1.1, p = 0.082). Among men with PI-RADS 1-3, the probability increased with increasing PSA density (p = 0.036). With PI-RADS 4-5 the probability of upgrading was high over the entire PSA density range. Conclusions: PSA density is a clinically important factor to predict upgrading from GG1 when bpMRI shows PI-RADS 1-3. In men with PI-RADS 4-5 on bpMRI, the probability of an undetected GG 2-5 cancer is high regardless of the PSA density.

Experience Measures after Radical Prostatectomy: A Register-Based Study Evaluating the Association between Patient-Reported Symptoms and Quality of Information.

Patient-reported data are important for quality assurance and improvement. Our main aim was to investigate the association between patient-reported symptoms among patients undergoing radical prostatectomy and their perceived quality of information before treatment. In this single-centre study, 235 men treated with robotic-assisted radical prostatectomy (RARP) between August 2017 and June 2019, responded to a follow-up questionnaire 20−42 months after surgery. A logistic regression analysis was performed to assess the association between patient-reported symptoms, measured with Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP), and the perceived quality of information. Adverse effects were defined as a higher EPIC score at follow-up than at baseline. The majority (77%) rated the general information as good. Higher EPIC-CP at follow-up was significantly associated with lower perceived quality of information, also after adjustment for age and level of education (bivariate model OR 1.12, 95% CI 1.07; 1.16, p < 0.001 and multiple model OR 1.12 95% CI 1.08; 1.17, p < 0.001). The share who rated information as good was almost identical among those who reported more symptoms after treatment and those who reported less symptoms (78.3% and 79.2%). Consequently, adverse effects could not explain the results. Our findings suggest a need for improvement of preoperative communication.

Construct Validity of the Questionnaire Quality From the Patients Perspective Adapted for Surgical Prostate Cancer Patients.

Patient-reported experience measures (PREMs) are important to capture the patients' voice. No such measure is routinely used for evaluation after robotic-assisted radical prostatectomy for prostate cancer. The aim of this study was to adapt the short version of the PREM questionnaire quality from the patients' perspective (QPP), and assess the construct validity of this version. Quality from the patients' perspective assesses 4 dimensions of quality of care. Involving discussion with user representatives, the QPP short version was adapted by adding 7 context-specific questions based on items from the Expanded Prostate Cancer Index Composite for Clinical Practice. This short version was answered on smartphone or tablet by 265 patients. We used exploratory factor analysis to assess dimensionality. For comparison with previous publications of the QPP, the analysis was repeated after mean imputation of missing values. The factor analysis identified 7 factors among the 30 analyzed items included in the analysis, explaining 64.9% of the variance. After imputation of missing, 2 factors explained 48.6% of the variance. None of these analysis captured the 4 dimensions of the QPP.

TECLA-an innovative technical approach for prostate cancer registries.

Objective: To present a code-driven, electronic database for patients TrEated with robotic-assisted radiCaL prostAtectomy (TECLA), developed at Innlandet Hospital (IH), Trust, Norway, for research, local quality control and to deliver data to the National Cancer Registry of Norway (CRN). Clinical data are directly extracted from the structured documentation in the electronic medical record (EMR).Materials and methods: The urological department at IH treats about 200 patients with robotic-assisted radical prostatectomy (RARP) annually. All consenting patients registered with the procedure code for RARP are included in TECLA. Clinical data are obtained automatically from the EMR, by structured forms. Patient-reported outcome and experience measures (PROMs and PREMs) are filled in by the patients on an iPad or a smartphone.Results: The basic construct of TECLA is presented. From August 2017 to June 2018, 200 men were treated with RARP, of which 182 (91%) provided consent for inclusion in the register. Of these, 97% completed the PROM survey before treatment and 91% at 3 months follow-up. PREMs were completed by 78%. All clinical variables for the hospital stay and for the 6-week follow-up were more than 95% complete.Conclusion: This entirely electronic surgical quality register is easy to use, both for patients and clinicians, and has a high capture rate. The data collection is linked to the clinicians' workflow, without double data entry, so entering data does not add any extra work. The register design can be used by other hospitals for various surgical procedures.