OC-0212: Patient-reported functional outcomes after hypofractionated radiation for prostate cancer

2020 ◽  
Vol 152 ◽  
pp. S106-S107
Author(s):  
J. NossiteR ◽  
A. Sujenthiran ◽  
T. Cowling ◽  
M. Parry ◽  
S. Charman ◽  
...  
BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e028132 ◽  
Author(s):  
Eoin Dinneen ◽  
Aiman Haider ◽  
Clare Allen ◽  
Alex Freeman ◽  
Tim Briggs ◽  
...  

IntroductionRobot-assisted laparoscopic prostatectomy (RALP) offers potential cure for localised prostate cancer but is associated with considerable toxicity. Potency and urinary continence are improved when the neurovascular bundles (NVBs) are spared during a nerve spare (NS) RALP. There is reluctance, however, to perform NS RALP when there are concerns that the cancer extends beyond the capsule of the prostate into the NVB, as NS RALP in this instance increases the risk of a positive surgical margin (PSM). The NeuroSAFE technique involves intraoperative fresh-frozen section analysis of the posterolateral aspect of the prostate margin to assess whether cancer extends beyond the capsule. There is evidence from large observational studies that functional outcomes can be improved and PSM rates reduced when the NeuroSAFE technique is used during RALP. To date, however, there has been no randomised controlled trial (RCT) to substantiate this finding. The NeuroSAFE PROOF feasibility study is designed to assess whether it is feasible to randomise men to NeuroSAFE RALP versus a control arm of ‘standard of practice’ RALP.MethodsNeuroSAFE PROOF feasibility study will be a multicentre, single-blinded RCT with patients randomised 1:1 to either NeuroSAFE RALP (intervention) or standard RALP (control). Treatment allocation will occur after trial entry and consent. The primary outcome will be assessed as the successful accrual of 50 men at three sites over 15 months. Secondary outcomes will be used to aid subsequent power calculations for the definitive full-scale RCT and will include rates of NS; PSM; biochemical recurrence; adjuvant treatments; and patient-reported functional outcomes on potency, continence and quality of life.Ethics and disseminationNeuroSAFE PROOF has ethical approval (Regional Ethics Committee reference 17/LO/1978). NeuroSAFE PROOF is supported by National Institute for Healthcare Research Research for Patient Benefit funding (NIHR reference PB-PG-1216-20013). Findings will be made available through peer-reviewed publications.Trial registration numberNCT03317990.


2019 ◽  
Vol 201 (Supplement 4) ◽  
Author(s):  
Daniel D. Joyce* ◽  
Aaron A. Laviana ◽  
Zighuo Zhao ◽  
Karen E. Hoffman ◽  
Li-Ching Huang ◽  
...  

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18531-e18531
Author(s):  
Kendrick Koo ◽  
Nathan Papa ◽  
Melanie Evans ◽  
Michael Jefford ◽  
Maarten J. IJzerman ◽  
...  

e18531 Background: Prostate cancer patients generally have good survival outcomes, but some survivors have poor functional outcomes with persisting symptoms and poor quality of life (QoL). Socio-economic status (SES), access to specialist care and place of residence (including rural, remote areas) are associated with poor survival. These variables may also impact survivorship outcomes, including QoL. This study aimed to identify and visualise geographical disparities in QoL outcomes for prostate cancer survivors. Methods: We extracted complete data for 7690 patients, including patient-reported EPIC-26 QoL questionnaire results (12 months post-treatment), from the Prostate Cancer Outcomes Registry–Victoria (PCOR-VIC), a population-based clinical quality outcomes registry. Patient-matched geographic coordinates were obtained through the Victorian Cancer Registry. Scores from each of the 5 EPIC-26 functional domains were visualised using geospatial maps and correlated to the Index of Relative Socio-economic Advantage and Disadvantage (IRSAD) and geographical remoteness. A composite score condensing all 5 domains into a single number (range 5 – 20) was created for succinct visualisation of functional outcomes. We analysed hotspots using the Getis-Ord Gi* statistic. Results: Scores in all 5 functional domains were positively correlated to IRSAD, which remained an independent predictor of low functional score when controlling for age, disease stage, treatment modality and geographical remoteness (p < 0.001 for all). Geographical remoteness predicted low functional score in all domains (p < 0.05) except Urinary Irritative but was not statistically significant when adjusted for IRSAD. The constructed composite score was significantly correlated to IRSAD and remoteness in a univariate model (p < 0.001). In a multivariate model, remoteness was not an independent predictor of outcome, but the composite score rose by 0.13 for each IRSAD decile (p < 0.001), with patients in the bottom decile of IRSAD more likely to have composite scores below median ( < 14) than those in the top decile (OR 1.8 CI 1.4-2.2 p < 0.001). The composite score allowed visualisation of functional outcomes in a single figure and identification of geographic hotspots with poor outcome. Conclusions: Systematic collection of long-term patient-reported outcomes is feasible. Geographical disparities in QoL outcome following prostate cancer treatment correlated with SES and remoteness, and we note the relative importance of SES over remoteness. A single composite score for EPIC-26 showed face-validity. Our results will allow targeted efforts to further understand the drivers of these findings and improve equity in survivorship outcomes for prostate cancer survivors. The methods developed in this study can be extended and re-deployed to evaluate outcomes in other jurisdictions and cancer types.


2020 ◽  
Vol 38 (7) ◽  
pp. 744-752 ◽  
Author(s):  
Julie Nossiter ◽  
Arunan Sujenthiran ◽  
Thomas E. Cowling ◽  
Matthew G. Parry ◽  
Susan C. Charman ◽  
...  

PURPOSE The aim of the current study was to determine patient-reported functional outcomes in men with prostate cancer (PCa) undergoing moderately hypofractionated (H-RT) or conventionally fractionated radiation therapy (C-RT) in a national cohort study. PATIENDS AND METHODS All men diagnosed with PCa between April 2014 and September 2016 in the English National Health Service undergoing C-RT or H-RT were identified in the National Prostate Cancer Audit and mailed a questionnaire at least 18 months after diagnosis. We estimated differences in patient-reported urinary, bowel, sexual, and hormonal function—Expanded Prostate Cancer Index Composite short-form 26 domain scores on a 0 to 100 scale—and health-related quality of life—EQ-5D-5L on a 0 to 1 scale—using linear regression with adjustment for patient, tumor, and treatment-related factors in addition to GI and genitourinary baseline function, with higher scores representing better outcomes. RESULTS Of the 17,058 men in the cohort, 77% responded: 8,432 men received C-RT (64.2%) and 4,699 H-RT (35.8%). Men in the H-RT group were older (age ≥ 70 years: 67.5% v 60.9%), fewer men had locally advanced disease (56.5% v 71.3%), were less likely to receive androgen-deprivation therapy (79.5% v 87.8%), and slightly more men had pretreatment genitourinary procedures (24.2% v 21.2%). H-RT was associated with small increases in adjusted mean Expanded Prostate Cancer Index Composite short-form 26 sexual (3.3 points; 95% CI, 2.1 to 4.5; P < .001) and hormonal function scores (3.2 points; 95% CI, 1.8 to 4.6; P < .001). These differences failed to meet established thresholds for a clinically meaningful change. There were no statistically significant differences in urinary or bowel function and quality of life. CONCLUSION This is the first national cohort study comparing functional outcomes after H-RT and C-RT reported by patients. These real-world results further support the use of H-RT as the standard for radiation therapy in men with nonmetastatic PCa.


BMC Cancer ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
David W. Donnelly ◽  
Linda C. Vis ◽  
Therese Kearney ◽  
Linda Sharp ◽  
Damien Bennett ◽  
...  

Abstract Background Quality of life among prostate cancer survivors varies by socio-demographic factors and treatment type received; however, less in known about differences in functional outcomes by method of presentation. We investigate differences in reported urinary, bowel, sexual and hormone-related problems between symptomatic and PSA-detected prostate cancer survivors. Methods A UK wide cross-sectional postal survey of prostate cancer survivors conducted 18-42 months post-diagnosis. Questions were included on presentation method and treatment. Functional outcome was determined using the EPIC-26 questionnaire. Reported outcomes were compared for symptomatic and PSA-detected survivors using ANOVA and multivariable log-linear regression. Results Thirty-five thousand eight hundred twenty-three men responded (response rate: 60.8%). Of these, 31.3% reported presenting via PSA test and 59.7% symptomatically. In multivariable analysis, symptomatic men reported more difficulty with urinary incontinence (Adjusted mean ratio (AMR): 0.96, 95% CI: 0.96-0.97), urinary irritation (AMR: 0.95, 95% CI: 0.95-0.96), bowel function (AMR: 0.97, 95% CI: 0.97-0.98), sexual function (AMR: 0.90, 95% CI: 0.88-0.92), and vitality/hormonal function (AMR: 0.96, 95% CI: 0.96-0.96) than PSA-detected men. Differences were consistent across respondents of differing age, stage, Gleason score and treatment type. Conclusion Prostate cancer survivors presenting symptomatically report poorer functional outcomes than PSA-detected survivors. Differences were not explained by socio-demographic or clinical factors. Clinicians should be aware that men presenting with symptoms are more likely to report functional difficulties after prostate cancer treatment and may need additional aftercare if these difficulties persist. Method of presentation should be considered as a covariate in patient-reported outcome studies of prostate cancer.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12071-12071
Author(s):  
Geraldine Pignot ◽  
Marion Picini ◽  
Patricia Marino ◽  
Naji Salem ◽  
Stanislas Rybikowski ◽  
...  

12071 Background: Patient-reported outcomes measures (PROMs) allow optimal evaluation of side effects of treatments and their impact on quality of life. In localized prostate cancer, these PROMs are an interesting tool for comparing the impact of different treatments. The objective of our study was to evaluate the feasibility of a PROMs assessment using a digital application and to analyze the functional outcomes at 1, 3 and 6 months for urinary continence and sexuality. Methods: Since May 2019, patients treated for localized prostate cancer in our center, regardless of the treatment choice, have been offered inclusion in a digital prospective program. PROMs questionnaires (EPIC-26, Q50 PR25, EQ- 5D and PRO-CTCAE) were sent via a dedicated digital application, before treatment (T0), at 1 month (M1), 3 months (M3), 6 months (M6) and 1 year. Program adherence was assessed by the proportion of patients who logged in to the app and the proportion of patients who responded to questionnaires. The first results, at T0, M1, M3 and M6, were analyzed for urinary continence and erectile function, and compared according to age, baseline characteristics and treatment strategy. Results: Between May 2019 and December 2020, 324 patients were included in the program. Thirty patients (9.3%) did not log into the app and 29 (8.9%) logged in but did not respond to the PROMs questionnaires sent out. The adherence rate was not related to age or treatment strategy. In the end, 265 patients (81.8%) answered the PROMs questionnaires, including 185 patients treated by surgery, 11 by brachytherapy, 15 by radiotherapy, 24 by radio-hormonotherapy and 30 under active surveillance. Before treatment (T0), 15.8% (42/265) of patients reported having urine leakage (at least once a week) and 41.5% (110/265) having poor or no erections. At M1, M3, and M6, the incontinence rate was 50.8%, 37.8% and 28.7% respectively, and the erectile dysfunction rate was 73.3%, 74.1% and 70.1% respectively. Sexual recovery was strongly associated with baseline erectile function (T0); patients with good sexual function at diagnosis had an erectile dysfunction rate of 53.8% at 1 month (versus 89.9% for patients with pre-existing sexual dysfunction, p < 0.001), and 51.1% at 3 months (versus 84.0%, p < 0.001). Age was not associated with continence or sexuality recovery. Patients treated with surgery had significantly poorer functional outcomes in terms of continence (p < 0.001) and sexuality (p < 0.001) compared to other strategies. Conclusions: The implementation of PROMs using a digital application achieves an adherence rate of over 80%. The incontinence rate decreases rapidly over the 6 months following treatment, while erectile dysfunction rate remains stable over time. Early side effects are more common after surgery, requiring appropriate supportive strategies.


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