Prostate Cancer Index Composite Scores Research Articles

Mirabegron Reduces Urinary Frequency and Improves Overactive Bladder Symptoms at 3 Months After 125I-brachytherapy for Prostate Cancer: An Open-Labeled, Randomized, Non–Placebo-Controlled Study

ObjectiveTo evaluate the additional effects of mirabegron to alpha-1 adrenergic antagonist on lower urinary tract symptoms of patients who underwent 125I-brachytherapy for prostate cancer. Patients and MethodsPatients who underwent 125I-brachytherapy for prostate cancer (cT1-cT3aN0M0) in a single institute between September 2016 and October 2018 were enrolled in the randomized, non-placebo, open-labeled, paralleled study. Patients were randomly distributed (1:1) to combination group (tamsulosin (0.2 mg/day) plus mirabegron (50 mg/day)) or tamsulosin-alone group after 125I -brachytherapy by envelope method. The primary endpoint was the change from baseline in mean voided volume per micturition 3 months after 125I brachytherapy. The secondary endpoints included the changes from baseline of International Prostate Symptom Score, Overactive Bladder Symptom Score, and Expanded Prostate Cancer Index Composite scores and 24 hours urinary frequency after 3 months after 125I brachytherapy. ResultsThe mean changes in volume voided per micturition in the combination (n = 108) and tamsulosin-alone (n = 110) groups were −62.5 (standard deviation, ±53.8) and −68.0 (standard deviation, ±52.7), respectively (P = .17). The change in Overactive Bladder Symptom Score in combination group (P = .02) was more moderate than in tamsulosin-alone group; and 24 hour urinary frequency in combination group was lower (P = .03) than in tamsulosin-alone group. Retention rates within 3 months after 125I-brachytherapy in the mirabegron and tamsulosin-alone groups were 7.3% (9/122) and 6.0% (7/118), respectively (P = .80). ConclusionTamsulosin and mirabegron combination therapy after 125I-brachytherapy did not improve voided volume per micturition compared to tamsulosin-only treatment. However, it could improve frequent urination and overactive bladder symptoms.

Oncologic and patient-reported outcomes after robot-assisted radical prostatectomy in men aged ≥75 years

ObjectiveThe present study aimed to evaluate oncologic outcomes, patient-reported outcomes (PROs), and frailty in older adult patients aged ≥75 years who underwent robot-assisted radical prostatectomy (RARP). Materials and methodsThis retrospective study reviewed the medical records of 752 patients who underwent RARP from July 2011 to May 2020. The PROs were evaluated by Expanded Prostate Cancer Index Composite questionnaire at baseline and 1 year after RARP. Patients were divided into 3 groups according to age at RARP: <70, 70–74, and ≥75 years. Oncologic outcomes and PROs were compared between the ≥75 and 70–74 years groups and between the ≥75 and <70 years groups. ResultsMedian follow up was 47 months. Of the 752 patients, 469, 216, and 74 were classified into the <70, 70–74, and ≥75 years groups, respectively. No significant differences were observed in the biochemical recurrence-free survival, cancer-specific survival, and overall survival among the groups. No significant differences were observed in the PROs and pad-free rates at baseline and 1 year after RARP among the groups. The full satisfaction (Expanded Prostate Cancer Index Composite score = 100) at 12 months after RARP was significantly higher in the ≥75 years group (27%) than in the <70 years group (15%, P = 0.045). ConclusionThe oncologic outcomes and PROs in select patients with prostate cancer aged ≥75 years were feasible and acceptable with RARP.

Patient-reported outcomes after open radical prostatectomy, laparoscopic radical prostatectomy and permanent prostate brachytherapy.

To assess patient-reported outcomes after open radical prostatectomy, laparoscopic radical prostatectomy and permanent prostate brachytherapy. patient-reported outcomes were evaluated using Expanded Prostate Cancer Index Composite scores at baseline and 1, 3, 6, 12 and 36months after treatment, respectively, using differences from baseline scores. Urinary function was the same in the three groups at baseline, but worse after surgery than after permanent prostate brachytherapy until 12months, and similar after open radical prostatectomy and permanent prostate brachytherapy and better than after laparoscopic radical prostatectomy at 36months. Urinary bother was significantly worse at 1month after surgery, but better after open radical prostatectomy than after permanent prostate brachytherapy and laparoscopic radical prostatectomy at 3months, after which symptoms improved gradually in all groups. Obstructive/irritative symptoms were worse after permanent prostate brachytherapy than after open radical prostatectomy at 36months, and worse after laparoscopic radical prostatectomy until 6months. Urinary incontinence was worse after surgery, particularly after 1 month. This symptom returned to the baseline level at 12months after open radical prostatectomy, but recovery after laparoscopic radical prostatectomy was slower. Bowel function after permanent prostate brachytherapy was significantly worse than after surgery at 1 month and this continued until 6months. Bowel bother was slightly worse at 3 and 6months after permanent prostate brachytherapy compared to these time points after surgery. Urinary function and bother were worst after laparoscopic radical prostatectomy, especially in the early postoperative phase, whereas urinary obstructive/irritative symptom, bowel function and bother were worse after permanent prostate brachytherapy. These findings are useful and informative for the treatment of patients with prostate cancer.

Four-Year Outcomes From a Prospective Phase II Clinical Trial of Moderately Hypofractionated Proton Therapy for Localized Prostate Cancer

Moderately hypofractionated radiation therapy represents an effective treatmentfor localized prostate cancer (PC). Although large randomized trials have reported the efficacy of photon-based hypofractionated therapy, hypofractionated proton therapy (HFPT) has not been extensively studied. This study was performed to determine the clinical and patient-reported outcomes for patients with PC treated with HFPT. Between 2010 and 2017, 184 men were enrolled on a trial of 70 Gy in 28 fractions of HFPT for low- to intermediate-risk PC. Acute and late toxicity was evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Patient-reported outcomes were measured by International Prostate Symptom Score, International Index of Erectile Function Questionnaire, and Expanded Prostate Cancer Index Composite scores. Median follow-up was 49.2 months. Enrolled patients had low-risk (n = 18), favorable intermediate-risk (n = 78), and unfavorable intermediate-risk (n = 88) PC. Four-year rates of biochemical-clinical failure-free survival were 93.5% (95% confidence interval, 89%-98%), 94.4% (89%-100%), 92.5% (86%-100%), and 93.8% (88%-100%) in the overall group and the low-risk, favorable intermediate-risk, and unfavorable intermediate-risk cohorts, respectively (log-rank P > .4). The incidence of acute grade 2 or higher gastrointestinal (GI) and urologic toxicities were 3.8% and 12.5%, respectively. The 4-year incidence of late grade 2 or higher urologic and GI toxicity was 7.6% (4%-13%) and 13.6% (9%-20%), respectively. One late grade 3 GI toxicity was reported. All late toxicities were transient. Patient-reported International Prostate Symptom, International Index of Erectile Function, and Expanded Prostate Cancer Index Composite scores had no significant long-term changes after completion of HFPT (Supplementary Table 1, available at https://doi.org/10.1016/j.ijrobp.2019.05.069). HFPT is associated with low rates of toxicity and does not appear to negatively affect 4-year patient reported urinary and bowel health. Further comparative analyses are warranted to better understand differences between proton and photon HFRT.

Evaluating the potential benefit of reduced planning target volume margins for low and intermediate risk patients with prostate cancer using real-time electromagnetic tracking

PurposeThe aim of this study is to quantify and describe the feasibility, clinical outcomes, and patient-reported outcomes of reduced planning target volume (PTV) margins for prostate cancer treatment using real-time, continuous, intrafraction monitoring with implanted radiation frequency transponder beacons. Methods and materialsFor this prospective, nonrandomized trial, the Calypso localization system was used for intrafraction target localization in 31 patients with a PTV margin reduced to 2 mm in all directions. A total of 1333 fractions were analyzed with respect to movement of the prostate, pauses and interruptions, and dosimetric data. Pre- and posttreatment quality-of-life scores were tracked at baseline, during treatment, and up to 24 months after treatment. ResultsThe mean time of daily treatment was 10 minutes, with 96.1% of all treatments falling within a 20-minute treatment window standard. On average, beacon motion exceeded 3 mm during active treatment only 1.76% of the time. The average length of treatment interruption was 34.2 seconds, with an average of 1 interruption every 3.39 fractions. The displacement or excursion of the prostate was the greatest in the superior or inferior dimension (0.11 mm and 0.09 mm, respectively) and anterior or posterior dimension (0.07 mm and 0.13 mm, respectively), followed by the left or right dimension (0.05 mm and 0.06 mm, respectively). At 6 months, patients demonstrated a smaller change in Expanded Prostate Cancer Index Composite scores than the ProtecT comparator group (decreased short-term morbidity). However, in the Bowel and Urinary domains at 12 and 24 months, there was no significant difference. ConclusionsOur data confirm and support that the use of Calypso tracking with intensity modulated radiation therapy reliably provides minimal disruption to daily treatments and overall time of treatment, with the PTV only moving outside of a 3-mm margin < 2% of the time. The use of a 3-mm PTV margin provides adequate dosimetric coverage while minimizing genitourinary and gastrointestinal toxicity.

Dosimetric parameters predict short-term quality-of-life outcomes for patients receiving stereotactic body radiation therapy for prostate cancer

PurposeStereotactic body radiation therapy (SBRT) is a treatment option for patients with localized prostate cancer, with reported clinical and health-related quality-of-life (QOL) outcomes comparable to standard fractionation radiation therapy. The goal of this study was to evaluate correlations between short-term QOL outcomes and dosimetric parameters to guide future prostate SBRT planning. Methods and materialsFrom 2010 to 2013, QOL data were prospectively collected from 75 patients enrolled in a prostate SBRT clinical trial. A comparison was made between Expanded Prostate Cancer Index Composite scores for patients with the top 25th percentile versus the bottom 75th percentile of the following dose-volume histogram parameters: planning target volume V100; bladder V50 and V100; and rectum V50, V80, V90, and V100. A linear mixed-effect model was used to estimate the difference between the 2 strata for each parameter. ResultsMedian follow-up was 12 months. Patients with planning target volume V100 volumes >120 cm3 had the worst reduction in urinary QOL. Urinary QOL was also decreased significantly in patients with bladder V100 volumes >5.5 cm3. Bowel QOL was decreased significantly in patients with rectal V90 and V100 volumes >4.2 and >1.5 cm3, respectively. ConclusionsPatients with large prostate size or large volumes of rectum and bladder that receive ≥90% of the prescribed radiation dose are more susceptible to short-term QOL decrements after prostate SBRT. These volumes should be minimized to maximize recovery to baseline QOL after prostate SBRT.

Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years. Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence. Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes.

Impact of pre‐implant lower urinary tract symptoms on postoperative urinary morbidity after permanent prostate brachytherapy

To assess the impact of baseline lower urinary tract symptoms on postoperative urinary morbidity in patients being treated for prostate cancer with 125-I permanent prostate brachytherapy. A total of 104 prostate cancer patients were enrolled in this study. Their urinary morbidity was followed up using the International Prostate Symptom Score and Expanded Prostate Cancer Index Composite for 12 months or more after permanent prostate brachytherapy. Patients were classified into two groups based on their baseline International Prostate Symptom Score: the low International Prostate Symptom Score group (score ≤ 7) and the high International Prostate Symptom Score group (score ≥ 8). Urinary morbidity was estimated in each group based on the results of the International Prostate Symptom Score and Expanded Prostate Cancer Index Composite measured before permanent prostate brachytherapy, and at 1, 3, 6, 9 and 12 months after the end of all radiation therapy. The overall mean total International Prostate Symptom Score, International Prostate Symptom Score quality of life score, and urinary-related scores for Expanded Prostate Cancer Index Composite were significantly worse at 1 month after the end of treatment, but they improved gradually after the treatment and recovered to the baseline level within 12 months. Even in the high-International Prostate Symptom Score group, the International Prostate Symptom Score and International Prostate Symptom Score Quality of Life score were significantly worse at 1-3 months after permanent prostate brachytherapy, and then recovered to the baseline level without prolongation. Although the urination-related Expanded Prostate Cancer Index Composite score in the high-International Prostate Symptom Score group was significantly worse at 1 month after permanent prostate brachytherapy in comparison with that in the low-International Prostate Symptom Score group, it recovered to the baseline level without prolongation. The present findings suggest that the presence of lower urinary tract symptoms before implantation does not prolong urinary morbidity after permanent prostate brachytherapy.

Acute Lower Urinary Tract Symptoms After Prostate Brachytherapy With Cesium-131

To evaluate the severity and interval to resolution of the acute lower urinary tract symptoms in men undergoing prostate brachytherapy (PB) with cesium-131 ((131)Cs). A longitudinal, prospective study of patients who had undergone PB with (131)Cs at our institution and had a minimum of 6 months of follow-up was performed. Urinary symptoms were assessed using the Expanded Prostate Cancer Index Composite. Patients were asked to complete a survey preoperatively and at 2 weeks and 1, 3, and 6 months postoperatively. The first 152 patients who underwent PB with (131)Cs at our institution were included in the present study. The mean Expanded Prostate Cancer Index Composite urinary summary score decreased significantly from baseline (86.4) at 2 weeks (59.2) and 1 month (62.2) after PB. These scores returned to the clinical baseline by 3 months (79.6) and to the statistical baseline by 6 months (84.0) after PB. The urinary subscales (function, bother, incontinence, irritative/obstructive) followed the same course in returning to the clinical and statistical baseline values. Similar patterns were seen when patients were stratified by PB as monotherapy. For patients undergoing combination therapy, the mean Expanded Prostate Cancer Index Composite scores returned to the clinical and statistical baseline values by 3 months after their procedure. In patients undergoing PB with (131)Cs, the postprocedure lower urinary tract symptoms generally returned to the clinical baseline by 3 months and the statistical baseline value by 6 months after PB.

Clinical Interpretation of the Expanded Prostate Cancer Index Composite-Short Form Sexual Summary Score

The Expanded Prostate Cancer Index Composite is a validated health related quality of life instrument that is commonly administered after prostate cancer treatment. We classified Expanded Prostate Cancer Index Composite-Short Form sexual summary scores into clinically meaningful groups. A development cohort of 561 patients undergoing radical prostatectomy was used to define sexual summary groups by correlation with their responses on the Sexual Health Inventory for Men. A separate validation cohort of 430 patients was used to compare Expanded Prostate Cancer Index Composite-Long Form sexual bother scores among these sexual summary groups. A sexual summary group score of 0 to 33, 34 to 45, 46 to 60, 61 to 75 and greater than 75 correlated with Sexual Health Inventory for Men groups of severe--1 to 7, moderate--8 to 11, mild/moderate--12 to 16, mild--17 to 21 and no erectile dysfunction--22 to 25, respectively. In the validation group mean sexual bother scores in each of the 5 sexual summary groups were significantly different from each other after controlling for patient age, stage, hormone treatment, marital status and nerve sparing (p <0.0001). Expanded Prostate Cancer Index Composite-Short Form sexual summary scores can be categorized into 5 groups for which excellent correlation is found with similar validated groups based on the Sexual Health Inventory for Men. Also, sexual bother scores are significantly different among the groups, showing that they represent discrete, clinically relevant cutoffs. This will help patients and physicians interpret Expanded Prostate Cancer Index Composite scores and help define potency for comparison among various prostate cancer treatments.

Expanded Prostate Cancer Index Composite Versus Incontinence Symptom Index and Sexual Health Inventory for Men to Measure Functional Outcomes After Prostatectomy

Evaluating quality of life outcomes following prostate cancer treatment is important because different treatments provide similar survival outcomes. A wide variety of quality of life surveys are used with an unknown correlation between domain specific and broad domain instruments. We compared the urinary and sexual outcome measures of the Expanded Prostate Cancer Index Composite, a broad domain instrument, to those of the Incontinence Symptom Index and the Sexual Health Inventory for Men, which are domain specific instruments. A total of 640 patients undergoing radical prostatectomy at our institution completed a combination of the Expanded Prostate Cancer Index Composite, Incontinence Symptom Index and Sexual Health Inventory for Men questionnaires. Matching functional domains were compared and correlation coefficients were calculated. Subgroup analysis was performed to compare specific information pertinent to recovery from prostatectomy. Correlations between measures of incontinence were 0.26 to 0.84, while indicators of sexual function were 0.70 to 0.84. Subgroup analysis comparing measures of irritative symptoms demonstrated weaker correlations. Analysis in patients reporting no sexual activity also showed a significantly lower correlation of scores than that in patients reporting sexual activity. Expanded Prostate Cancer Index Composite scores generally demonstrate strong correlations with corresponding Incontinence Symptom Index and Sexual Health Inventory for Men scores, indicating similar measurements of information. Divergent correlations between irritative scores as well as scores in men who are not sexually active may indicate that the Expanded Prostate Cancer Index Composite has more descriptive validity in this population. Wider use of a single broad domain instrument such as the Expanded Prostate Cancer Index Composite to assess outcomes after prostate cancer treatment may improve clinical efficiency and allow comparative quality of life research across treatment types in the future.

Analysis Linking UCLA PCI With Expanded Prostate Cancer Index Composite: An Evaluation of Health Related Quality of Life in Japanese Men With Localized Prostate Cancer

We evaluated the correspondence between UCLA PCI and the Extended Prostate Cancer Index Composite for Japanese patients with localized prostate cancer. A total of 385 patients treated with retropubic radical prostatectomy, external beam radiation, hormonal therapy or select watchful waiting from 2002 to 2006 were enrolled. For this study we used equipercentile linking, a technique that identifies scores on the 2 measures that have the same percentile rank. Urinary and sexual functions showed a strong correlation (r = 0.85 and 0.93, respectively, p <0.0001). In contrast, the correlation for bowel function was relatively weak (r = 0.47, p <0.0001). The correlations of each Extended Prostate Cancer Index Composite bother domain with UCLA PCI were 0.6 (p <0.0001). The linking between each scale of the Extended Prostate Cancer Index Composite and UCLA PCI domains showed that an Extended Prostate Cancer Index Composite urinary function score of 73 was equivalent to a UCLA PCI score of 60. With regard to urinary bother an Extended Prostate Cancer Index Composite score of 69 to 84 was equivalent to a UCLA PCI score of 75. A sexual function score of 18 on UCLA PCI corresponded to an Extended Prostate Cancer Index Composite score of 12 and a sexual bother score of 50 on UCLA PCI corresponded to an Extended Prostate Cancer Index Composite score of 56 to 88. The urinary and sexual domains of UCLA PCI and the Extended Prostate Cancer Index Composite showed strong correlations. In contrast, the correlation for the bowel domain was relatively weak. The results of the linking analysis between UCLA PCI and the Extended Prostate Cancer Index Composite may have implications useful for their interpretation.

Measuring patients’ expectations regarding health-related quality-of-life outcomes associated with prostate cancer surgery or radiotherapy

Objectives Establishing realistic health-related quality-of-life (HRQOL) expectations before the choice of cancer treatment is made is an important goal of patient counseling. We prospectively studied the pretreatment expectations of prostate cancer-specific HRQOL with an adapted Expanded Prostate Cancer Index Composite instrument. Methods Baseline pretreatment Expanded Prostate Cancer Index Composite scores, pretreatment expectation scores, and 1-year posttreatment scores were prospectively collected for 50 patients undergoing radical prostatectomy or external beam radiotherapy. The pretreatment expectations and observed HRQOL scores at 1 year after treatment were compared for the urinary incontinence, urinary irritation, bowel, sexual, and hormonal domains. Results The expectation scores did not differ from the HRQOL scores at 1 year for urinary irritation, bowel function, and the hormonal domain. However, the sexual domain expectations were 22.5% greater than observed sexual domain scores 1 year after treatment ( P <0.0001, 99% confidence interval 11 to 34) for both surgery and radiotherapy subjects. Anxiety, depression, education level, and income did not correlate with the expectations for HRQOL outcomes. A modest correlation was found between optimism and greater expectations for the sexual domain (Pearson correlation coefficient 0.38, P <0.001). Conclusions Measuring HRQOL expectations before treatment may elucidate discrepancies between patient expectations and observed outcomes. This pilot study found that patients’ expectations regarding urinary and bowel outcomes more closely reflected their eventual observed outcome than did their expectations regarding sexual outcome.

847 POSTER Difference in rectal dosimetry between pre-plan and post-implant analysis in transperineal interstitial brachytherapy for prostate cancer

Stereotactic body radiation therapy (SBRT) is a treatment option for patients with localized prostate cancer, with reported clinical and health-related quality-of-life (QOL) outcomes comparable to standard fractionation radiation therapy. The goal of this study was to evaluate correlations between short-term QOL outcomes and dosimetric parameters to guide future prostate SBRT planning.From 2010 to 2013, QOL data were prospectively collected from 75 patients enrolled in a prostate SBRT clinical trial. A comparison was made between Expanded Prostate Cancer Index Composite scores for patients with the top 25th percentile versus the bottom 75th percentile of the following dose-volume histogram parameters: planning target volume V100; bladder V50 and V100; and rectum V50, V80, V90, and V100. A linear mixed-effect model was used to estimate the difference between the 2 strata for each parameter.Median follow-up was 12 months. Patients with planning target volume V100 volumes > 120 cm3 had the worst reduction in urinary QOL. Urinary QOL was also decreased significantly in patients with bladder V100 volumes > 5.5 cm3. Bowel QOL was decreased significantly in patients with rectal V90 and V100 volumes > 4.2 and > 1.5 cm3, respectively.Patients with large prostate size or large volumes of rectum and bladder that receive ≥ 90% of the prescribed radiation dose are more susceptible to short-term QOL decrements after prostate SBRT. These volumes should be minimized to maximize recovery to baseline QOL after prostate SBRT.