Prostate Cancer Index Composite Bowel Research Articles

Quality of life of muscle-invasive bladder cancer patients after brachytherapy-based treatment: A cross-sectional study.

To determine the quality of life (QoL) of patients with muscle-invasive bladder cancer (MIBC) who underwent bladder-sparing treatment with high-dose-rate brachytherapy, and compare their QoL with an age-matched general Dutch population. We conducted a single-center, prospective, descriptive cross-sectional study. MIBC patients who underwent brachytherapy-based bladder sparing treatment in Arnhem, The Netherlands from January 2016 to June 2021, were requested to complete the following questionnaires: European Organization for Research and Treatment of Cancer (EORTC) generic (QLQ-C30), bladder cancer-specific (QLQ-BLM30), and expanded prostate cancer index composite bowel (EPIC-50). Mean scores were calculated and compared with general Dutch population. The mean global health status/QoL score of the treated patients was 80.6. High scores were noted in the functional scales, including physical (86.8), role (85.6), emotional (88.6), cognitive (88.3), and social functioning (88.9), while the main reported complains were related to fatigue (21.9) and urinary symptoms (25.1). Compared to the general Dutch population, significant differences were visible in global health status/QoL (80.6 vs. 75.7), pain (9.0 vs. 17.8), insomnia (23.3 vs. 15.2), and constipation (13.3 vs. 6.8). However, in no case did the mean score differ by more than ten points, which was considered clinically relevant. With a mean global health status/QoL score of 80.6, the patients after brachytherapy-based bladder sparing treatment have a good QoL. We found no clinically relevant difference in QoL comparing with an age-matched general Dutch population. The outcome strengthens the idea that this treatment option should be discussed with all patients eligible for brachytherapy-based treatment.

Postoperative or Salvage Proton Radiotherapy for Prostate Cancer After Radical Prostatectomy.

PurposePostprostatectomy radiation improves disease control, but limited data exist regarding outcomes, toxicities, and patient-reported quality of life with proton therapy.Method and MaterialsThe first 102 patients who were enrolled on an outcome tracking protocol between 2006 and 2017 and treated with double-scattered proton therapy after prostatectomy were retrospectively reviewed. Eleven (11%) received adjuvant radiation, while 91 (89%) received salvage radiation. Seventy-four received double-scattered proton therapy to the prostate bed only. Twenty-eight received a double-scattered proton therapy prostate-bed boost after prostate-bed and pelvic-node treatment. Eleven adjuvant patients received a median dose of 66.6 GyRBE (range, 66.0-70.2). Ninety-one salvage patients received a median dose of 70.2 GyRBE (range, 66.0-78.0). Forty-five patients received androgen deprivation therapy for a median 9 months (range, 1-30). Toxicities were scored using Common Terminology Criteria for Adverse Events v4.0 criteria, and patient-reported quality-of-life data were reviewed.ResultsThe median follow-up was 5.5 years (range, 0.8-11.4 years). Five-year biochemical relapse-free and distant metastases-free survival rates were 72% and 91% for adjuvant patients, 57% and 97% for salvage patients, and 57% and 97% overall. Acute and late grade 3 or higher genitourinary toxicity rates were 1% and 7%. No patients had grade 3 or higher gastrointestinal toxicity. Acute and late grade 2 gastrointestinal toxicities were 5% and 2%. The mean values and SDs of the International Prostate Symptom Score, International Index of Erectile Function, and Expanded Prostate Cancer Index Composite bowel function and bother were 7.5 (SD = 5.9), 10.2 (SD = 8.3), 92.8 (SD = 11.1), and 91.2 (SD = 6.4), respectively, at baseline, and 12.1 (SD = 9.1), 10.1 (SD = 6.7), 87.3 (SD = 18), and 86.7 (SD = 13.8) at the 5-year follow-up.ConclusionHigh-dose postprostatectomy proton therapy provides effective long-term biochemical control and freedom from metastasis, with low acute and long-term gastrointestinal and genitourinary toxicity.

Five-year Outcomes for Moderately Accelerated Hypofractionated Proton Therapy for Prostate Cancer

To report 5-year outcomes of a prospective trial of image-guided moderately accelerated hypofractionated proton therapy (AHPT) for prostate cancer. This is a retrospective review of the outcomes of the first 586 consecutive prostate cancer patients who were enrolled on an IRB-approved outcome tracking trial between 2008 and 2015, and treated with double-scattered moderately AHPT. There were 275 low-risk (LR) and 311 intermediate-risk (IR) patients, including 161 favorable intermediate-risk (FIR) and 150 unfavorable-risk (UIR) patients. LR patients were treated with 2.5 GyRBE per fraction to a median of 70.0 GyRBE (range, 64.4 to 72.5 GyRBE) and IR patients to a median of 72.5 GyRBE (range 67.5 to 72.5 GyRBE). Nineteen patients (13 with UIR disease) received androgen deprivation therapy (ADT) for a median of 6 months (range, 2 to 15 months). No patient had SpaceOAR placement. Toxicities were graded prospectively according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, and prospectively or retrospectively for versions 4.0 and 5.0. Patient-reported quality of life data were reviewed. Median follow-up was 6.6 years (range, 0.6 to 11.4). The 5-year rates of freedom from biochemical and clinical disease progression (FFBCP) were 96.9%, 98.4%, and 95.6% in the overall group, and LR and IR subsets, respectively. The five-year rates of FFBCP were 98.7% and 92.0% for the FIR and UIR subsets. ADT was not associated with improvement in FFBCP for patients with UIR disease on univariate analysis (p = 0.2827). Actuarial 5-year rates of late radiation-related CTCAE versions 3.0, 4.0, and 5.0 grade 2 gastrointestinal (GI) toxicities, with medical intervention defined as inclusive of any prescription medication, were 9.4%, 10.1% and 10.1%. The corresponding grade 3 GI toxicities were 1.0%, 1.0%, and 1.0%, and grade 3 genitourinary (GU) toxicities were 1.4%, 0.9% and 0.9% respectively. Grade 3 GI toxicity was significantly related to Absolute Rectal Volume receiving 70 GyRBE (Rec V70) (p = 0.0218). The optimal cut point for Rec V70 was 6.9 cc with a 5-year risk of grade 3 GI toxicity with <6.9cc of 0% (95% CI: n/a) and with >6.9 of 3.1% (95% CI: 1.4%-6.7%). There were no grade 4 or higher GI or GU toxicities. The mean and standard deviation of the International Prostate Symptom Score, and Expanded Prostate Cancer Index Composite bowel function and bother were 6 (SD = 5), 97 (SD = 7), and 94 (SD = 6), respectively at baseline, and 6 (SD = 6), 92 (SD = 13) and 92 (SD = 9) at the 5-year follow-up. Image-guided moderately AHPT 5-year outcomes show high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes in this cohort of patients. These results are comparable to the 5-year results of our prospective trials of conventionally fractionated proton therapy for patients with LR and IR prostate cancer.

Rectal Hydrogel Spacer Improves Late Gastrointestinal Toxicity Compared to Rectal Balloon Immobilization After Proton Beam Radiation Therapy for Localized Prostate Cancer: A Retrospective Observational Study

Our purpose was to compare dosimetric parameters and late gastrointestinal outcomes between patients treated with proton beam therapy (PBT) for localized prostate cancer with rectal balloon immobilization versus a hydrogel rectal spacer. Patients with localized, clinical stage T1-4 prostate adenocarcinoma were treated at a single institution using conventionally fractionated, dose-escalated PBT from 2013 to 2018. Patient-reported gastrointestinal toxicity was prospectively collected, and the incidence of rectal bleeding was retrospectively reviewed from patient records. One hundred ninety-two patients were treated with rectal balloon immobilization, and 75 were treated with a rectal spacer. Rectal hydrogel spacer significantly improved rectal dosimetry while maintaining excellent target coverage. The 2-year actuarial rate of grade 2+ late rectal bleeding was 19% and 3% in the rectal balloon and hydrogel spacer groups, respectively (P = .003). In univariable analysis, the probability of grade 2+ rectal bleeding was significantly correlated with increasing rectal dose. In multivariable analysis, only receipt of spacer hydrogel (hazard ratio, 0.145; P = .010) and anticoagulation use (hazard ratio, 5.019; P < .001) were significantly associated with grade 2+ bleeding. At 2-year follow-up, patient-reported Expanded Prostate Cancer Index Composite bowel quality of life composite scores were less diminished in the hydrogel spacer group (absolute mean difference, 5.5; P = .030). Use of rectal hydrogel spacer for prostate PBT is associated with a significantly lower incidence of clinically relevant, late rectal bleeding and lower decrement in long-term, patient-reported bowel quality of life compared with rectal balloon immobilization. Our results suggest that hydrogel spacer may improve rectal sparing compared with rectal balloon immobilization during PBT for prostate cancer.

Microbial Diversity and Composition Is Associated with Patient-Reported Toxicity during Chemoradiation Therapy for Cervical Cancer

Patients receiving pelvic radiation for cervical cancer experience high rates of acute gastrointestinal (GI) toxicity. The association of changes in the gut microbiome with bowel toxicity from radiation is not well characterized. Thirty-five patients undergoing definitive chemoradiation therapy (CRT) underwent longitudinal sampling (baseline and weeks 1, 3, and 5) of the gut microbiome and prospective assessment of patient-reported GI toxicity. DNA was isolated from stool obtained at rectal examination and analyzed with 16S rRNA sequencing. GI toxicity was assessed with the Expanded Prostate Cancer Index Composite instrument to evaluate frequency, urgency, and discomfort associated with bowel function. Shannon diversity index was used to characterize alpha (within sample) diversity. Weighted UniFrac principle coordinates analysis was used to compare beta (between sample) diversity between samples using permutational multivariate analysis of variance. Linear discriminant analysis effect size highlighted microbial features that best distinguish categorized patient samples. Gut microbiome diversity continuously decreased over the course of CRT, with the largest decrease at week 5. Expanded Prostate Cancer Index Composite bowel function scores also declined over the course of treatment, reflecting increased symptom burden. At all individual time points, higher diversity of the gut microbiome was linearly correlated with better patient-reported GI function, but baseline diversity was not predictive of eventual outcome. Patients with high toxicity demonstrated different compositional changes during CRT in addition to compositional differences in Clostridia species. Over time, increased radiation toxicity is associated with decreased gut microbiome diversity. Baseline diversity is not predictive of end-of-treatment bowel toxicity, but composition may identify patients at risk for developing high toxicity.

Proceedings to the 6th Annual Conference of the Particle Therapy Cooperative Group North America (PTCOG-NA): 14-16 October 2019, Hosted by Miami Cancer Institute, part of Baptist Health South Florida, Miami, FL, USA.

Proceedings to the 6th Annual Conference of the Particle Therapy Cooperative Group North America (PTCOG-NA): 14-16 October 2019, Hosted by Miami Cancer Institute, part of Baptist Health South Florida, Miami, FL, USA.

Phase 1 Trial of SBRT to the Prostate Fossa After Prostatectomy

The primary objective was to evaluate the maximum tolerated dose (within 10weeks after treatment) associated with increasing hypofractionation to the prostate fossa (PF). We hypothesized that escalating the dose per fraction (fx) to the PF would have acceptable toxicity. Tested dose levels (DLs) were 3.6Gy×15 fx (DL1); 4.7Gy×10 fx (DL2); and 7.1Gy×5 fx (DL3). Escalation followed a 6+6 rules-based design with 12 patients required at the maximum tolerated dose. Dose-limiting toxicity was defined as grade (G) ≥3, gastrointestinal (GI) or genitourinary (GU) toxicity by National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03). Patients completed quality-of-life questionnaires. Twenty-four patients with indications for adjuvant or salvage radiation therapy (RT) enrolled (6 at DL1 and 2; 12 at DL3). All patients had at least 6months of follow-up (median follow-up, 14.1months). Four patients received concurrent androgen deprivation therapy. No G≥3 GI or GU toxicity was seen at any DL; 2of 6 patients in the DL1 group, 3 of 6 in DL2, and 7 of 12 in DL3 experienced G2 GI toxicity during RT. Except in 1 patient, all acute G2 GI toxicity resolved by 10weeks. Three of 12 patients reported an increase to G1 and G2 GU toxicity in the 2weeks after RT in groups DL1 and DL2 and 1 of 12 patients in DL3. At week 2 after RT, decline in the 26-item Expanded Prostate Cancer Index Composite bowel domain met criteria for a minimally important difference in 71% of patients. At week 10, 1 of 6, 2 of 6, and 7 of 11 patients at DLs 1, 2, and 3, respectively, still met minimally important difference criteria. International Prostate Symptom Scores worsened 2weeks after treatment but improved by 6 to 10weeks. Dose escalation up to 7.1Gy×5 fx to the PF was completed without acute G≥3 toxicity. There was transient G2 rectal toxicity at all DLs during and immediately after RT. We must perform long-term follow-up and assessment of late toxicity of SBRT to the PF.

Initial report of the genitourinary and gastrointestinal toxicity of post-prostatectomy proton therapy for prostate cancer patients undergoing adjuvant or salvage radiotherapy

Purpose: To report acute and late genitourinary (GU) and gastrointestinal (GI) toxicities associated with post-prostatectomy proton therapy (PT).Methods: The first 100 consecutive patients from 2010 to 2016 were retrospectively assessed. Baseline characteristics, prospectively graded CTCAE v4.0 toxicities, and patient-reported outcomes were reported. Late outcomes were reported for 79 patients with 3 months minimum follow up. Toxicity-free survival Kaplan-Meier curves were estimated. Logistic regression assessed associations between toxicities and clinical and treatment characteristics (p < .05 significance).Results: Median age, months after surgery, and months of follow-up were respectively 64 years (range 42–77), 25 (5–216), and 25 (0–47). PT received was 70.2 Gy (RBE) (89%), salvage (93%), prostate bed only (80%), pencil beam scanning (86%), with IMRT (31%), and with androgen deprivation (34%). Acute and late maximum toxicities, respectively were: GU grade 0 (14%; 18%), 1 (71%; 62%), 2 (15%; 20%), ≥3 (0), and GI: grade 0 (66%; 73%), 1 (34%; 27%), ≥2 (0). Toxicity-free survival at 24 months was GU grade 2 (83%) and GI grade 1 (74%). Mean (±std dev) baseline International Prostate Symptom Score (IPSS), International Index of Erectile Function, and Expanded Prostate Cancer Index Composite bowel function and bother were 6.6 ± 6.1, 10.5 ± 7.3, 90.9 ± 10.8, 93.3 ± 11.2, respectively, and largely unchanged at 2 years: 6.3 ± 3.6, 11.1 ± 6.3, 92.8 ± 5.8, and 90.9 ± 10.3. On multivariate analysis, baseline IPSS (p = .009) associated with GU grade 2 acute toxicity. Bladderless-CTV median dose, V30, and V40 associated with GU grade 2 acute toxicity and maximum dose with late (Ps <0.05). For GI, on multivariate analysis, baseline bowel function (p = .033) associated with acute grade 1 toxicity. Rectal minimum and median dose, V10, and V20, and anterior rectal wall median dose and V10 through V65 associated with acute grade 1 GI toxicity (Ps < .05).Conclusions: Post-prostatectomy PT for prostate cancer is feasible with a favorable GU and GI toxicity profile acutely and through early follow up.

Quality of Life in Long-term Survivors of Muscle-Invasive Bladder Cancer

Health-related quality of life (QOL) has not been well-studied in survivors of muscle-invasive bladder cancer (MIBC). The present study compared long-term QOL in MIBC patients treated with radical cystectomy (RC) versus bladder-sparing trimodality therapy (TMT). This cross-sectional bi-institutional study identified 226 patients with nonmetastatic cT2-cT4 MIBC, diagnosed in 1990 to 2011, who were eligible for RC and were disease free for ≥2years. Six validated QOL instruments were administered: EuroQOL EQ-5D, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire and EORTC MIBC module, Expanded Prostate Cancer Index Composite bowel scale, Cancer Treatment and Perception Scale, and Impact of Cancer, version 2. Multivariable analyses of the mean QOL scores were conducted using propensity score matching. The response rate was 77% (n=173). The median follow-up period was 5.6years. Of the 173 patients, 64 received TMT and 109, RC. The median interval from diagnosis to questionnaire completion was 9years after TMT and 7years after RC (P=.009). No significant differences were found in age, gender, comorbidities, tobacco history, performance status, or tumor stage. On multivariable analysis, patients who received TMT had better general QOL by 9.7 points of 100 compared with those who had received RC (P=.001) and higher physical, role, social, emotional, and cognitive functioning by 6.6 to 9.9 points (P≤.04). TMT was associated with better bowel function by 4.5 points (P=.02) and fewer bowel symptoms by 2.7 to 7.1 points (P≤.05). The urinary symptom scores were similar. TMT was associated with better sexual function by 8.7 to 32.1 points (P≤.02) and body image by 14.8 points (P<.001). The patients who underwent TMT reported greater informed decision-making scores by 13.6 points (P=.01) and less concern about the negative effect of cancer by 6.8 points (P=.006). The study limitations included missing baseline QOL data and different follow-up times. Both TMT and RC result in good long-term QOL outcomes in MIBC survivors, supporting TMT as a good alternative to RC for selected patients. Whether TMT leads to superior QOL requires prospective validation.

A Prospective Pilot Study of Single 19 Gy Fraction High-Dose-Rate Brachytherapy for Favorable-Risk Adenocarcinoma of the Prostate

Objective: To evaluate the acute genitourinary (GU) and gastrointestinal (GI) toxicities, health-related quality of life (HRQOL) factors, biochemical control rates, and technical feasibility of high-dose-rate (HDR) brachytherapy as monotherapy for prostate cancer delivered in a single fraction. Methods: A single-institution, prospective pilot study evaluating 6 patients with low- and intermediate-risk prostate cancer treated in 2013. Patients received a single 19 Gy fraction as HDR monotherapy. Patients were assessed according to the Common Terminology Criteria for Adverse Events version 4.0, the International Index of Erectile Function (IIEF-5), the International Prostate Symptom Score (IPSS), the Expanded Prostate Cancer Index Composite–Bowel Assessment (EPIC-Bowel), a Quality of Life (QOL) Assessment, and an institutionally designed quality of care (QOC) questionnaire. Biochemical failure was defined as a prostate-specific antigen (PSA) nadir plus 2 ng/ml. Results: Patients tolerated the implant well and were all discharged home the same day by approximately 4 pm. Median follow-up was 9 months. No grade 3, 4 or 5 toxicities were observed. Two of the 6 patients (33%) experienced grade 2 GU toxicity. One patient (17%) experienced grade 2 GI toxicity. HRQOL bowel and urinary assessments revealed a majority of complaints at 3 months, which returned to baseline at 6 months. Conclusion: HDR brachytherapy as monotherapy for favorable-risk prostate cancer using one implant delivered in a single 19 Gy dose has acceptable acute toxicities and HRQOL reports similar to alternative treatment options.

Impact of late anorectal dysfunction on quality of life after pelvic radiotherapy

Anorectal dysfunction is common after pelvic radiotherapy. This study aims to explore the relationship of subjective and objective anorectal function with quality of life (QoL) and their relative impact in patients irradiated for prostate cancer. Patients underwent anal manometry, rectal barostat measurement, and completed validated questionnaires, at least 1 year after prostate radiotherapy (range 1-7 years). QoL was measured by the Fecal Incontinence Quality of Life scale (FIQL) and the Expanded Prostate Cancer Index Composite Bowel domain (EPICB)-bother subscale. Severity of symptoms was rated by the EPICB function subscale. Anorectal function was evaluated in 85 men. Sixty-three percent suffered from one or more anorectal symptoms. Correlations of individual symptoms ranged from r = 0.23 to r = 0.53 with FIQL domains and from r = 0.36 to r = 0.73 with EPICB bother scores. They were strongest for fecal incontinence and urgency. Correlations of anal sphincter pressures, rectal capacity, and sensory thresholds ranged from r = 0.00 to r = 0.42 with FIQL domains and from r = 0.15 to r = 0.31 with EPICB bother scores. Anal resting pressure correlated most strongly. Standardized regression coefficients for QoL outcomes were largest for incontinence, urgency, and anal resting pressure. Regression models with subjective parameters explained a larger amount (range 26-92 %) of variation in QoL outcome than objective parameters (range 10-22 %). Fecal incontinence and rectal urgency are the symptoms with the largest influence on QoL. Impaired anal resting pressure is the objective function parameter with the largest influence. Therefore, sparing the structures responsible for an adequate fecal continence is important in radiotherapy planning.

Tu1058 Late Anorectal Complaints After Pelvic Radiotherapy: Which Symptom Has the Largest Impact on Quality of Life?

BACKGROUND: Late anorectal toxicity is a frequent adverse event of pelvic radiotherapy. It comprises different symptoms such as fecal incontinence, rectal blood loss and urgency. To optimize treatment modalities it is important to know which symptoms have the largest impact on quality of life (QoL). Especially urgency and fecal incontinence are expected to have a profound impact. Our goal was to determine the relative impact of individual anorectal symptoms on QoL in patients irradiated for prostate cancer. METHODS: Patients who underwent evaluation of their anorectal function after prostate irradiation, were asked to complete two validated questionnaires to measure their QoL and the prevalence and severity of anorectal complaints at least one year after radiotherapy. QoL was measured by the Fecal Incontinence Quality of Life scale (FIQL) and the Expanded Prostate Cancer Index Composite Bowel domain (EPICB) bother subscale. The prevalence and severity of anorectal complaints was measured by the EPICB function subscale. RESULTS: Eighty-five men (mean age 72 yrs; range 53 84 yrs), completed the questionnaires (mean time after radiotherapy 2 yrs; range 1-7 yrs). Loose or liquid stools was reported by 48%, rectal urgency by 31%, bloody stool by 22%, frequent defecation by 22%, fecal incontinence by 18%, painful defecation by 18% and abdominal cramps by 12% of the patients. Mean spearman rank correlation coefficients of FIQL domains and EPICB bother scores with individual symptoms ranged 0.23 0.53 for FIQL domains and 0.36 0.73 for EPICB bother scores. The correlation coefficients indicated a strong relationship of fecal incontinence and urgency and a moderate relationship of rectal blood loss and frequent defecation with QoL outcomes. Multiple regression analysis revealed that standardized regression coefficients (β) for QoL outcomes were largest for urgency and incontinence. For urgency they were 0.39 with the lifestyle domain and 0.38 with the coping domain (p < 0.001). For incontinence they ranged between 0.29 and 0.52 (all domains p < 0.001) with the lifestyle, coping, depression and embarrassment domain. Urgency (β = 0.37) and incontinence (β = 0.30) also had the largest impact on bother as measured by the EPICB. CONCLUSIONS: These results support the hypothesis that fecal incontinence and rectal urgency have the largest impact on QoL in patients with anorectal radiation toxicity. Other symptoms such as frequent defecation and lower abdominal cramps also contribute, but less profoundly. This underscores the importance of preventing fecal incontinence and urgency and to optimize treatment modalities.

Acute bowel morbidity after prostate brachytherapy with cesium-131

Purpose The present study evaluates the severity and time to resolution of bowel symptoms in men undergoing prostate brachytherapy (PB) with cesium-131 ( 131Cs). Methods and Materials A longitudinal, prospective study of patients who had undergone PB with 131Cs at a single institution was performed. All patients were asked to complete the Expanded Prostate Cancer Index Composite preoperatively and at 2 weeks and 1, 3, and 6 months postoperatively. Outcomes were analyzed using descriptive statistics and Student’s t test. Results The first 142 patients to have undergone PB with 131Cs at our institution were included in the study. The mean Expanded Prostate Cancer Index Composite bowel summary score at baseline was 90.1 ± 11.0 compared with 71.5 ± 22.8 ( p = 0.000), 70.1 ± 20.7, 87.1 ± 13.8 ( p = 0.01), and 90.7 ± 9.2 ( p = 0.70) at 2 weeks and 1, 3, and 6 months postoperatively, respectively. Conclusions In men undergoing PB as monotherapy with 131Cs, bowel symptoms returned to baseline by 3 months after the procedure. For patients undergoing PB with 131Cs as part of combination therapy, bowel symptoms return to their post–external beam radiotherapy, pre-PB baseline by 3 months after the procedure.

Cross-linked hyaluronan gel improves the quality of life of prostate cancer patients undergoing radiotherapy

Purpose To test the hypothesis that cross-linked hyaluronan gel (Hylaform) does not affect the quality of life (QOL) of prostate cancer patients undergoing radiotherapy. Methods and Materials Thirty-five patients with early stage prostate cancer underwent high-dose-rate brachytherapy to 2200 cGy and intensity modulated radiation therapy to 5040 cGy on a prospective study. Thirty patients received a single transperineal injection of 9-mL Hylaform between the prostate and rectum under transrectal ultrasound guidance immediately before the start of radiotherapy. Hylaform increased the separation between the prostate and rectum by 6–19 mm (median, 13 mm) at the start of radiotherapy. Five patients did not receive Hylaform and served as controls. We assessed gastrointestinal-related QOL using Expanded Prostate Cancer Index Composite Bowel Bother scores immediately before the start of and during the last week of radiotherapy. Results At the beginning of intensity modulated radiation therapy, daily mean rectal doses were 74 ± 8 cGy (mean ± standard deviation) and 105 ± 25 cGy (mean ± standard deviation) with vs. without Hylaform, respectively ( p = 0.01). Expanded Prostate Cancer Index Composite Bowel Bother scores decreased by 0 ± 3 (mean ± standard deviation) and 11 ± 14 (mean ± standard deviation) in patients who did and did not receive Hylaform, respectively ( p = 0.03). Conclusions Hylaform increased the separation between the prostate and rectum and decreased the mean rectal dose, thereby improving the gastrointestinal-related acute QOL of prostate cancer patients undergoing radiotherapy. Patients will be followed up long term to determine if the improvement in acute QOL also translates into an improvement in late QOL.