ASTRO Journals' Data Sharing Policy and Recommended Best Practices.

Transparency, openness, and reproducibility are important characteristics in scientific publishing. Although many researchers embrace these characteristics, data sharing has yet to become common practice. Nevertheless, data sharing is becoming an increasingly important topic among societies, publishers, researchers, patient advocates, and funders, especially as it pertains to data from clinical trials. In response, ASTRO developed a data policy and guide to best practices for authors submitting to its journals. ASTRO's data sharing policy is that authors should indicate, in data availability statements, if the data are being shared and if so, how the data may be accessed

Public reporting of outcomes in radiation oncology: the National Prostate Cancer Audit.

The public reporting of patient outcomes is crucial for quality improvement and informing patient choice. However, outcome reporting in radiotherapy, despite being a major component of cancer control, is extremely sparse globally. Public reporting has many challenges, including difficulties in defining meaningful measures of treatment quality, limitations in data infrastructure, and fragmented health insurance schemes. The National Prostate Cancer Audit (NPCA), done in the England and Wales National Health Service (NHS), shows that it is feasible to develop outcome indicators for radiotherapy treatment, including patient-reported outcomes. The NPCA provides a transparent mechanism for comparing the performance of all NHS providers, with results accessible to patients, providers, and policy makers. Using the NPCA as a case study, we discuss the development of a radiotherapy-outcomes reporting programme, its impact and future potential, and the challenges and opportunities to develop this approach across other tumour types and in different health systems

Patient‐reported outcomes after 3‐dimensional conformal, intensity‐modulated, or proton beam radiotherapy for localized prostate cancer

BACKGROUND: Recent studies have suggested differing toxicity patterns for patients with prostate cancer who receive treatment with 3‐dimensional conformal radiotherapy (3DCRT), intensity‐modulated radiotherapy (IMRT), or proton beam therapy (PBT). METHODS: The authors reviewed patient‐reported outcomes data collected prospectively using validated instruments that assessed bowel and urinary quality of life (QOL) for patients with localized prostate cancer who received 3DCRT (n = 123), IMRT (n = 153) or PBT (n = 95). Clinically meaningful differences in mean QOL scores were defined as those exceeding half the standard deviation of the baseline mean value. Changes from baseline were compared within groups at the first post‐treatment follow‐up (2‐3 months from the start of treatment) and at 12 months and 24 months. RESULTS: At the first post‐treatment follow‐up, patients who received 3DCRT and IMRT, but not those who received PBT, reported a clinically meaningful decrement in bowel QOL. At 12 months and 24 months, all 3 cohorts reported clinically meaningful decrements in bowel QOL. Patients who received IMRT reported clinically meaningful decrements in the domains of urinary irritation/obstruction and incontinence at the first post‐treatment follow‐up. At 12 months, patients who received PBT, but not those who received IMRT or 3DCRT, reported a clinically meaningful decrement in the urinary irritation/obstruction domain. At 24 months, none of the 3 cohorts reported clinically meaningful changes in urinary QOL. CONCLUSIONS: Patients who received 3DCRT, IMRT, or PBT reported distinct patterns of treatment‐related QOL. Although the timing of toxicity varied between the cohorts, patients reported similar modest QOL decrements in the bowel domain and minimal QOL decrements in the urinary domains at 24 months. Prospective randomized trials are needed to further examine these differences. Cancer 2013. © 2013 American Cancer Society. Prostate cancer patients who receive 3‐dimensional conformal radiotherapy, intensity‐modulated radiotherapy, or proton beam therapy report distinct patterns of treatment‐related quality of life. Although the timing of toxicity varies between cohorts, patients report similar modest quality‐of‐life decrements in the bowel domain and minimal QOL decrements in the urinary domains at 24 months.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/97476/1/27956_ftp.pd

Interfractional Variations in the Setup of Pelvic Bony Anatomy and Soft Tissue, and Their Implications on the Delivery of Proton Therapy for Localized Prostate Cancer

Purpose To quantify daily variations in the anatomy of patients undergoing radiation therapy for prostate carcinoma, to estimate their effect on dose distribution, and to evaluate the effectiveness of current standard planning and set-up approaches employed in proton therapy. Methods We used series of CT data, which included the pre-treatment scan, and between 21 and 43 in-room scans acquired on different treatment days, from 10 patients treated with intensity-modulated radiation therapy at Morristown Memorial Hospital. Variations in femur rotation angles, thickness of subcutaneous adipose tissue, and physical depth to the distal surface of the prostate for lateral beam arrangement were recorded. Proton dose distributions were planned with the standard approach. Daily variations in the location of the prescription iso-dose were evaluated. Results In all 10 datasets, substantial variation was observed in the lateral tissue thickness (standard deviation of 1.7–3.6 mm for individual patients, variations of over 5 mm from the planning CT observed in all series), and femur rotation angle (standard deviation between 1.3–4.8°, with the maximum excursion exceeding 10° in 6 out of 10 datasets). Shifts in the position of treated volume (98% iso-dose) were correlated with the variations in the lateral tissue thickness. Conclusions Analysis suggests that, combined with image-guided set-up verification, the range compensator expansion technique prevents loss of dose to target due to femur rotation and soft tissue deformation, in the majority of cases. Anatomic changes coupled with the uncertainties of particle penetration in tissue restrict possibilities for margin reduction in proton therapy of prostate cancer

Dosimetric impacts of endorectal balloon in CyberKnife stereotactic body radiation therapy (SBRT) for early‐stage prostate cancer

Abstract Purpose In SBRT for prostate cancer, higher fractional dose to the rectum is a major toxicity concern due to using smaller PTV margin and hypofractionation. We investigate the dosimetric impact on rectum using endorectal balloon (ERB) in prostate SBRT. Materials and Methods Twenty prostate cancer patients were included in a retrospective study, ten with ERB and 10 without ERB. Optimized SBRT plans were generated on CyberKnife MultiPlan for 5 × 7.25 Gy to PTV under RTOG‐0938 protocol for early‐stage prostate cancer. For the rectum and the anterior half rectum, mean dose and percentage of volumes receiving 50%, 80%, 90%, and 100% prescription dose were compared. Results: Using ERB, mean dose to the rectum was 62 cGy (P = 0.001) lower per fraction, and 50 cGy (P = 0.024) lower per fraction for the anterior half rectum. The average V50%, V80%, V90%, and V100% were lower by 9.9% (P = 0.001), 5.3% (P = 0.0002), 3.4% (P = 0.0002), and 1.2% (P = 0.005) for the rectum, and lower by 10.4% (P = 0.009), 8.3% (P = 0.0004), 5.4% (P = 0.0003), and 2.1% (P = 0.003) for the anterior half rectum. Conclusions: Significant reductions of dose to the rectum using ERB were observed. This may lead to improvement of the rectal toxicity profiles in prostate SBRT

Prostate-Specific Antigen Screening and 15-year Prostate Cancer Mortality:A Secondary Analysis of the CAP Randomized Clinical Trial

Key PointsQuestion  In men aged 50 to 69 years, does a single invitation for a prostate-specific antigen (PSA) screening test reduce prostate cancer mortality at 15-year follow-up compared with no invitation for testing?Findings  In this secondary analysis of a randomized clinical trial of 415 357 men aged 50 to 69 years randomized to a single invitation for PSA screening (n = 195 912) or a control group without PSA screening (n = 219 445) and followed up for a median of 15 years, risk of death from prostate cancer was lower in the group invited to screening (0.69% vs 0.78%; mean difference, 0.09%) compared with the control group.Meaning  Compared with no invitation for routine PSA testing, a single invitation for a PSA screening test reduced prostate cancer mortality at a median follow-up of 15 years, but the absolute mortality benefit was small.AbstractIMPORTANCE The Cluster randomized trial of PSA testing for Prostate cancer (CAP) reported no effect of prostate specific antigen (PSA) screening on prostate cancer mortality at median 10-year follow-up (primary outcome), but the long-term effects of PSA screening on prostate cancer mortality remain unclear.OBJECTIVE To evaluate the effect of a single invitation for PSA screening on the pre-specified secondary outcome of prostate cancer-specific mortality at a median of 15 years’ follow-up, compared to a control group not invited for screening. DESIGN, SETTING, PARTICIPANTS Cluster randomized trial of men aged 50-69 identified from 573 primary-care practices in England and Wales. Primary-care practices were randomized between 09/25/2001 and 08/24/2007 and men were enrolled between 01/08/2002 and 01/20/2009. Follow-up was completed on 03/31/2021. INTERVENTION A single invitation for a PSA screening test with subsequent diagnostic tests if PSA≥3.0ng/ml, compared to standard practice (control). MAIN OUTCOMES AND MEASURES The primary outcome was reported previously. Of eight prespecified secondary outcomes, results of four were reported previously. The four remaining pre-specified secondary outcomes at 15-year follow-up were prostate cancer-specific mortality, all-cause mortality, and prostate cancer stage and Gleason grade at diagnosis.RESULTS Of 415,357 randomized men (mean [SD] age: 59.0 [5.6] years), 98% were analyzed in these analyses. Overall, 12,013 and 12,958 men with prostate cancers were diagnosed in the intervention and control groups (15-year cumulative risks 7.1% and 6.9% respectively). At a median 15-year follow-up, 1,199 (0.69%) men in the intervention group and 1,451 (0.78%) men in the control group died of prostate cancer (rate ratio [RR] 0.92 [95% CI 0.85, 0.99]; p=0.03). Compared to the control group, the PSA screening intervention increased detection of low-grade (Gleason score [GS]≤6; 2.2% versus 1.6%;p&lt;0.001) and localized (T1/T2; 3.6% versus 3.1%;p&lt;0.001) disease, but not intermediate (GS=7), high-grade (GS≥8), locally-advanced (T3) or distally-advanced (T4/N1/M1) tumors. There were 45,084 all-cause deaths (23.2%) in the intervention group and 50,336 deaths (23.3%) in the control group respectively (RR 0.97 [95% CI 0.94, 1.01]; p=0.11). Eight deaths in the intervention and seven deaths in the control group were related to a diagnostic biopsy or prostate cancer treatment.CONCLUSIONS AND RELEVANCE A single invitation for PSA screening, compared to standard practice without routine screening, reduced the secondary outcome of prostate cancer deaths at a median follow-up of 15-years. However, the absolute reduction in deaths was small.<br/

Contemporary accuracy of death certificates for coding prostate cancer as a cause of death : Is reliance on death certification good enough? A comparison with blinded review by an independent cause of death evaluation committee

BACKGROUND: Accurate cause of death assignment is crucial for prostate cancer epidemiology and trials reporting prostate cancer-specific mortality outcomes. METHODS: We compared death certificate information with independent cause of death evaluation by an expert committee within a prostate cancer trial (2002-2015). RESULTS: Of 1236 deaths assessed, expert committee evaluation attributed 523 (42%) to prostate cancer, agreeing with death certificate cause of death in 1134 cases (92%, 95% CI: 90%, 93%). The sensitivity of death certificates in identifying prostate cancer deaths as classified by the committee was 91% (95% CI: 89%, 94%); specificity was 92% (95% CI: 90%, 94%). Sensitivity and specificity were lower where death occurred within 1 year of diagnosis, and where there was another primary cancer diagnosis. CONCLUSIONS: UK death certificates accurately identify cause of death in men with prostate cancer, supporting their use in routine statistics. Possible differential misattribution by trial arm supports independent evaluation in randomised trials

Impact of an Expanded Definition of Family History on Outcomes of Active Surveillance for Prostate Cancer

PURPOSE: Despite family history being an established risk factor for prostate cancer, the role of a broader definition of family history inclusive of not just prostate cancer but other genetically related malignancies has not been investigated in the active surveillance population. Here, we evaluate the impact of an expanded definition of family history on active surveillance outcomes. MATERIALS AND METHODS: Patients undergoing active surveillance for prostate cancer at Massachusetts General Hospital from 1997-2019 with detailed data available on family cancer history were identified. Primary outcome was biopsy progression-free survival, and secondary outcomes were treatment-free survival, adverse pathological features at prostatectomy, and biochemical recurrence after treatment. Statistical analyses were conducted using the Kaplan-Meier method and Cox regression. RESULTS: Among 855 evaluable patients, 300 (35.1%) patients had any family history of prostate cancer, and 95 (11.1%) had a family history of related malignancies suggestive of a hereditary cancer syndrome. Family history of prostate cancer alone was not associated with biopsy progression, whereas family history suggestive of a hereditary cancer syndrome was associated with a significantly increased risk of biopsy progression (HR 1.43, 95%CI 1.01-2.02), independent of other known clinicopathological risk factors in multivariable analysis. Similarly, family history suggestive of a hereditary cancer syndrome was associated with significantly lower treatment-free survival (HR 1.58, 95%CI 1.14-2.18) in multivariable analysis. No significant association was found between family history and adverse features on surgical pathology or biochemical recurrence. CONCLUSIONS: An expanded family history suggestive of a hereditary cancer syndrome is an independent predictor of biopsy progression during active surveillance. Men with such a family history may still be offered active surveillance but should be counseled regarding the higher risk of disease progression