scholarly journals Measuring Radiation Toxicity Using Circulating Cell-Free DNA in Prostate Cancer Patients

2021 ◽  
Author(s):  
Natalie A. Lockney ◽  
Randal H. Henderson ◽  
Steven G. Swarts ◽  
Zhenhuan Zhang ◽  
Bingrong Zhang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Radiation Toxicity ◽  
Cell Free Dna ◽  
Free Dna ◽  
Dose Volume ◽  
Gu Toxicity ◽  
Patient Reported ◽  
Gi Toxicity ◽  
Grade 3 ◽  
To Receive

Abstract Background After radiation therapy (RT), circulating plasma cell-free DNA (cfDNA) released in response to RT damage to tissue can be measured within hours. We examined for a correlation between cfDNA measured during the first week of therapy and early and late gastrointestinal (GI) and genitourinary (GU) toxicity. Material and Methods Patients were eligible for enrollment if they planned to receive proton or photon RT for nonmetastatic prostate cancer in the setting of an intact prostate or after prostatectomy. Blood was collected before treatment and on sequential treatment days for the first full week of therapy. Toxicity assessments were performed at baseline, weekly during RT, and 6 months and 12 months after RT. Data were analyzed to examine correlations among patient-reported GI and GU toxicities. Results Fifty-four patients were evaluable for this study. Four (7%) and 3 (6%) patients experienced acute and late grade 2 GI toxicity, respectively. Twenty-two (41%) and 18 (35%) patients experienced acute and late grade 2 GU toxicity, respectively. No patients developed grade 3 or higher toxicity. Grade 2 acute GI toxicity, but not grade 2 acute GU toxicity, was significantly correlated with pre-RT cfDNA levels and on all days 1, 2, 3, 4, and 5 of RT (P < .005). Grade 2 late GI toxicity, but not GU toxicity, was significantly correlated with pre-RT cfDNA levels (P = .021). Conclusions Based on this preliminary study, cfDNA levels can potentially predict the subset of patients destined to develop GI toxicity during prostate cancer treatment. Given that the toxicity profiles of the various fractionations and modalities are highly similar, the data support the expectation that cfDNA could provide a biological estimate to complement the dose-volume histogram. A test of this hypothesis is under evaluation in a National Cancer Institute–funded multi-institutional study.

scholarly journals Circulating Cell-Free DNA Correlates with Body Integral Dose and Radiation Modality in Prostate Cancer

2020 ◽  
Vol 7 (2) ◽  
pp. 21-30
Author(s):  
Natalie A. Lockney ◽  
Randal Henderson ◽  
Steven G. Swarts ◽  
Zhenhuan Zhang ◽  
Bingrong Zhang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Field Size ◽  
Cell Free Dna ◽  
Integral Dose ◽  
Prostate Bed ◽  
Free Dna ◽  
Patient Reported ◽  
To Receive ◽  
Circulating Cell Free Dna

Abstract Purpose The RadTox assay measures circulating cell-free DNA released in response to radiotherapy (RT)-induced tissue damage. The primary objectives for this clinical trial were to determine whether cell-free DNA numbers measured by the RadTox assay are (1) correlated with body integral dose, (2) lower with proton RT compared with photon RT, and (3) higher with larger prostate cancer RT fields. Patients and Methods Patients planned to receive proton or photon RT for nonmetastatic prostate cancer in the setting of an intact prostate or postprostatectomy were eligible for the trial. Plasma was collected pre-RT and at 5 additional daily collection points beginning 24 hours after the initiation of RT. Data from 54 evaluable patients were analyzed to examine any correlations among RadTox scores with body-integral dose, RT modality (photon versus proton), and RT field size (prostate or prostate bed versus whole pelvis). Results Body integral dose was significantly associated with the peak post-RT RadTox score (P = .04). Patients who received photon RT had a significant increase in peak post-RT RadTox score (P = .04), average post-RT RadTox score (P = .04), and day-2 RadTox score (all minus the pre-RT values for each patient) as compared with patients who received proton RT. Field size was not significantly associated with RadTox score. Conclusion RadTox is correlated with body integral dose and correctly predicts which patients receive proton versus photon RT. Data collection remains ongoing for patient-reported RT toxicity outcomes to determine whether RadTox scores are correlated with toxicity.

Patient-reported quality of life in men with TURP undergoing proton therapy for prostate cancer.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 220-220 ◽  
Author(s):  
Derek Lee ◽  
Bradford S. Hoppe ◽  
Tamara L. Smith ◽  
Christopher G. Morris ◽  
Romaine Charles Nichols ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Proton Therapy ◽  
Toxicity Assessment ◽  
Gu Toxicity ◽  
Significant Difference ◽  
Patient Reported ◽  
Grade 3

220 Background: We report on quality of life (QOL) and early toxicity following proton therapy (PT) among men with prostate cancer who underwent transurethral resection of the prostate (TURP) prior to treatment. Methods: Between 2006 and 2010, 1,540 patients were treated definitively with PT for prostate cancer at UFPTI and enrolled on a prospective IRB-approved outcomes protocol. One hundred of the men had received a TURP before PT. Baseline comorbidities, medications, expanded prostate index composite (EPIC) score, international prostate symptom score (IPSS), and CTCAE vs.3 toxicity assessment were collected prospectively. The Kaplan-Meier product limit method was used to estimate freedom from toxicity. Results: Men who had TURP prior to PT had lower EPIC scores at baseline and at all followup points for urinary function, urinary incontinence, and urinary summary (Table). The TURP group also had lower EPIC bowel bother, bowel function, and bowel summary at baseline, 6-month, and 1-year followup. EPIC urinary bother, urinary irritation/obstruction, and subscales did not show a statistically significant difference at baseline, but they did show lower scores for the TURP group at variable follow-up time points. The IPSS scores among the TURP group did not show a statistical difference from the non-TURP group, except at the 6-month follow-up time point. Toxicity assessment showed that the 2-year and 3-year cumulative incidence of grade 3 GU toxicity rate in the pretreatment TURP group were 14% and 18%, respectively. Conclusions: Pretreatment TURP was associated with both a high incidence of physician-assessed toxicity and inferior patient-reported QOL scores both before and after PT treatment. Studies investigating QOL and toxicity after specific prostate cancer therapies should stratify patients by pretreatment TURP. Longer follow-up and further evaluation of risk factors for grade 3 GU toxicity among this cohort are needed. [Table: see text]

scholarly journals Proton Therapy of Prostate and Pelvic Lymph Nodes for High Risk Prostate Cancer: Acute Toxicity

2021 ◽  
Vol 8 (2) ◽  
pp. 41-50
Author(s):  
Richard Choo ◽  
David W. Hillman ◽  
Thomas Daniels ◽  
Carlos Vargas ◽  
Jean Claude Rwigema ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Acute Toxicity ◽  
Lymph Nodes ◽  
Seminal Vesicles ◽  
Pelvic Lymph Nodes ◽  
Gu Toxicity ◽  
Risk Prostate Cancer ◽  
Gi Toxicity ◽  
Grade 3

Abstract Purpose To assess acute gastrointestinal (GI) and genitourinary (GU) toxicities of intensity-modulated proton therapy (IMPT) targeting the prostate/seminal vesicles and pelvic lymph nodes for prostate cancer. Materials and Methods A prospective study (ClinicalTrials.gov: NCT02874014), evaluating moderately hypofractionated IMPT for high-risk or unfavorable intermediate-risk prostate cancer, accrued a target sample size of 56 patients. The prostate/seminal vesicles and pelvic lymph nodes were treated simultaneously with 6750 and 4500 centigray radiobiologic equivalent (cGyRBE), respectively, in 25 daily fractions. All received androgen-deprivation therapy. Acute GI and GU toxicities were prospectively assessed from 7 GI and 9 GU categories of the Common Terminology Criteria for Adverse Events (version 4), at baseline, weekly during radiotherapy, and 3-month after radiotherapy. Fisher exact tests were used for comparisons of categorical data. Results Median age was 75 years. Median follow-up was 25 months. Fifty-five patients were available for acute toxicity assessment. Sixty-two percent and 2%, respectively, experienced acute grade 1 and 2 GI toxicity. Grade 2 GI toxicity was proctitis. Sixty-five percent and 35%, respectively, had acute grade 1 and 2 GU toxicity. The 3 most frequent grade 2 GU toxicities were urinary frequency, urgency, and obstructive symptoms. None had acute grade ≥ 3 GI or GU toxicity. The presence of baseline GI and GU symptoms was associated with a greater likelihood of experiencing acute GI and GU toxicity, respectively. Of 45 patients with baseline GU symptoms, 44% experienced acute grade 2 GU toxicity, compared with only 10% among 10 with no baseline GU symptoms (P = 0.07). Although acute grade 1 and 2 GI and GU toxicities were common during radiotherapy, most resolved at 3 months after radiotherapy. Conclusion A moderately hypofractionated IMPT targeting the prostate/seminal vesicles and regional pelvic lymph nodes was well tolerated with no acute grade ≥ 3 GI or GU toxicity. Patients with baseline GU symptoms had a higher rate of acute grade 2 GU toxicity.

Intensity-modulated radiation therapy (IMRT) for prostate cancer: Toxicity and biochemical control in 183 Chinese patients from a single institution in Hong Kong.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 101-101
Author(s):  
D. M. Poon
Keyword(s):  
Prostate Cancer ◽  
Prostate Gland ◽  
Risk Groups ◽  
Target Volume ◽  
Biochemical Failure ◽  
Localized Prostate Cancer ◽  
Chinese Patients ◽  
Gu Toxicity ◽  
Gi Toxicity ◽  
Grade 3

101 Background: To report the biochemical outcome and the acute and late toxicities in 183 Chinese patients with clinically localized prostate cancer treated with IMRT. Methods: Between May 2001 and November 2009, 183 patients with clinically localized prostate cancer were treated with IMRT at the Prince of Wales Hospital. Median follow-up was 44 months (range 8.5 to 112 months).Treatment was planned using an inverse-planning approach, and the beams were delivered by dynamic multileaf collimation. Four-field box technique was used for pelvic irradiation (pelvic RT) if indicated in phase I and IMRT was used for prostate boost in phase II. The median age of the patients was 71.4 (range 45 to 82). According to the NCCN risk classification, 18 (9.8%), 47 (25.7%) and 118 (64.5%) patients belong to favorable, intermediate, and unfavorable risk group respectively. The median prescription dose of the planning target volume of the prostate gland (PTV-G) is 72Gy (range from 66 to 76Gy). 77 patients (42.1%) received pelvic RT. 129 patients (70%) received neoadjuvant hormone and 106 patients (57.9%) received adjuvant hormone. Acute and late toxicities were scored according to the Common Terminology Criteria for Adverse Events Version 4.02. Biochemical failure was defined according to the Houston definition (absolute PSA nadir plus 2ng/ml dated at the call). Results: The 5-year actuarial biochemical-failure free survival for patients in favorable, intermediate and unfavorable risk groups were 95%, 80%, and 83% respectively. 3 patients (1.6%) experienced grade 3 acute gastrointestinal (GI) toxicity. There were no grade 3 acute genitourinary (GU) toxicity. There was no grade 4 acute GI or GU toxicity. 14 patients (7.7%) developed grade 2 late GI toxicity and 8 patients (4.4%) developed grade 3 late GI toxicity. 5 patients (2.7%) developed grade 2 late GU toxicity and 5 patients (2.7%) developed grade 3 late GU toxicity. There was no grade 4 late GI or GU toxicity. Conclusions: These data demonstrate that IMRT for prostate cancer is feasible and safe in Chinese population. The early biochemical outcome is encouraging and the grade 3 late GI and GU complications were below 5%. No significant financial relationships to disclose.

Moderate hypofractionated helical tomotherapy for localized prostate cancer: preliminary report of an observational prospective study

2019 ◽  
Vol 105 (6) ◽  
pp. 516-523 ◽  
Author(s):  
Francesco Cuccia ◽  
Rosario Mazzola ◽  
Stefano Arcangeli ◽  
Gianluca Mortellaro ◽  
Vanessa Figlia ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prospective Study ◽  
Phase Ii ◽  
Helical Tomotherapy ◽  
Single Case ◽  
Localized Prostate Cancer ◽  
Tolerability Profile ◽  
Gu Toxicity ◽  
Gi Toxicity ◽  
Grade 3

Objective: To report preliminary findings of a phase II study exploring the clinical outcomes of moderate hypofractionated radiotherapy performed with helical tomotherapy (HT) using computed tomography–magnetic resonance imaging–based planning for localized prostate cancer. Methods: The phase II prospective study received ethics approval from our institutional ethics committee. A dose of 60 Gy/20 fractions for low–intermediate risk prostate cancer by means of HT was explored. Primary endpoints of the study were acute and late gastrointestinal (GI) and genitourinary (GU) toxicities. Secondary endpoints were quality of life and biochemical-free survival. Results: A total of 35 patients were included in this interim report. At the time of the analysis, median follow-up was 36 months (range, 13–62). Acute GI toxicity was recorded as follows: grade 1 in 34% and grade 2 in 14%; acute GU toxicity was grade 1 in 71% and grade 2 in 11%. For the entire population of the study, no acute toxicities ⩾ grade 3 occurred. A single case of late grade 3 GU toxicity was registered, whereas no late GI toxicity ⩾grade 3 was recorded. At the time of the final assessment, no biochemical failure was detected. Conclusions: The preliminary results of the present phase II trial, using HT for moderate hypofractionation in localized prostate cancer, are optimal. In fact, HT guaranteed an acceptable tolerability profile with low rates of GU and GI side effects and, more specifically, no acute severe adverse events were recorded. Long-term findings are warranted.

scholarly journals Measuring Radiation Toxicity Using Circulating Cell-Free DNA in Prostate Cancer Patients

2019 ◽  
Vol 105 (1) ◽  
pp. S175
Author(s):  
N.A. Lockney ◽  
S.G. Swarts ◽  
J. Li ◽  
C.G. Morris ◽  
R.H. Henderson ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Patients ◽  
Radiation Toxicity ◽  
Cell Free Dna ◽  
Free Dna ◽  
Circulating Cell Free Dna

scholarly journals Salvage Reirradiation Options for Locally Recurrent Prostate Cancer: A Systematic Review

2021 ◽  
Vol 11 ◽  
Author(s):  
Jim Zhong ◽  
Finbar Slevin ◽  
Andrew F. Scarsbrook ◽  
Maria Serra ◽  
Ananya Choudhury ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Systematic Review ◽  
Radiation Therapy ◽  
Dose Rate ◽  
Systematic Reviews ◽  
External Beam Radiation ◽  
Modified Delphi ◽  
Patient Reported ◽  
Gi Toxicity ◽  
Grade 3

BackgroundReirradiation using brachytherapy (BT) and external beam radiation therapy (EBRT) are salvage strategies with locally radiorecurrent prostate cancer. This systematic review describes the oncologic and toxicity outcomes for salvage BT and EBRT [including Stereotactic Body Radiation Therapy (SBRT)].MethodsAn International Prospective Register of Systematic Reviews (PROSPERO) registered (#211875) study was conducted using Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) guidelines. EMBASE and MEDLINE databases were searched from inception to December 2020. For BT, both low dose rate (LDR) and high dose rate (HDR) BT techniques were included. Two authors independently assessed study quality using the 18-item Modified Delphi technique.ResultsA total of 39 eligible studies comprising 1967 patients were included (28 BT and 11 SBRT). In 35 studies (90%), the design was single centre and/or retrospective and no randomised prospective studies were found. Twelve BT studies used LDR only, 11 HDR only, 4 LDR or HDR and 1 pulsed-dose rate only. All EBRT studies used SBRT exclusively, four with Cyberknife alone and 7 using both Cyberknife and conventional linear accelerator treatments. Median (range) modified Delphi quality score was 15 (6-18). Median (range) follow-up was 47.5 months (13-108) (BT) and 25.4 months (21-44) (SBRT). For the LDR-BT studies, the median (range) 2-year and 5-year bRFS rates were 71% (48-89.5) and 52.5% (20-79). For the HDR-BT studies, the median (range) 2-year and 5-year bRFS rates were 74% (63-89) and 51% (45-65). For the SBRT studies, the median (range) 2-year bRFS for the SBRT group was 54.9% (40-80). Mean (range) acute and late grade≥3 GU toxicity rates for LDR-BT/HDR-BT/SBRT were 7.4%(0-14)/2%(0-14)/2.7%(0-8.7) and 13.6%(0-30)/7.9%(0-21.3%)/2.7%(0-8%). Mean (range) acute and late grade≥3 GI toxicity rates for LDR-BT/HDR-BT/SBRT were 6.5%(0-19)/0%/0.5%(0-4%) and 6.4%(0-20)/0.1%(0-0.9)/0.2%(0-1.5). One third of studies included Patient Reported Outcome Measures (PROMs).ConclusionsSalvage reirradiation of radiorecurrent prostate cancer using HDR-BT or SBRT provides similar biochemical control and acceptable late toxicity. Salvage LDR-BT is associated with higher late GU/GI toxicity. Challenges exist in comparing BT and SBRT from inconsistencies in reporting with missing data, and prospective randomised trials are needed.

Postoperative radiotherapy for prostate cancer: Sooner or later?

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16157-e16157
Author(s):  
S. Igdem ◽  
M. U. Abacioglu ◽  
G. Alço ◽  
R. Ibrahimov ◽  
A. Kefeli ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Lymph Node ◽  
Radical Prostatectomy ◽  
Postoperative Radiotherapy ◽  
Lymph Node Involvement ◽  
Biochemical Control ◽  
Gu Toxicity ◽  
Node Involvement ◽  
Gi Toxicity ◽  
Grade 3

e16157 Background: To report our experience with adjuvant or salvage radiotherapy for prostate cancer and to assess the tolerance of the patients. Methods: The charts of 139 men who received postoperative radiotherapy (RT) after radical prostatectomy (RP) between 1997–2007 in two institutions were retrospectively analyzed. Thirty-seven percent received adjuvant RT and 63% salvage RT. The median age was 65 years (range: 43–80). Pathologic Gleason score was 2–6 in 24%, 7 in 56%, and 8–10 in 20%. Seminal vesicle involvement was reported in 34%, positive surgical margins in 72%, lymph node involvement in 7%, capsular perforation in 61%, and perineural invasion in 73% of the patients. The median PSA level before RT was 0.29ng/ml (range: 0–19ng/mL). Median time from RP to RT was 3 months (range, 1–12 months) in the adjuvant setting, and 27 months (range, 2–96 months) in the salvage setting. Nineteen percent received radiation to the pelvis, 81% to the prostate bed only. The median dose to the prostatic bed was 66.6Gy (range: 60–76Gy). Before, during or after RT 49% received androgen deprivation for a median of 6 months (range, 3–48 months). Biochemical failure is defined as a post-RT PSA level >0.2ng/mL. Results: The median follow up time was 41 months (range, 12–133 months). At 4 years, for the entire cohort biochemical control, metastasis free survival, and overall survival was 68%, 92%, and 94%, respectively. Although there was a significant difference in favor of the adjuvantly treated group for biochemical control (81% vs 60%, p = 0.03) in univariate analysis, multivariate analysis demonstrated that higher preoperative PSA level (p = 0.02), and lymph node involvement (p = 0.02) predicted for a worse PSA outcome. No grade 3 acute gastrointestinal (GI) or genitourinary (GU) toxicity was reported during the treatment. At 4 years, 4% of patients had Grade 2 late GI toxicity, 0.7% had grade 3 late GI, and 0.7% brade 4 late GI toxicity, while 16% of patients reported late grade 2 GU, and 4% had late grade 3 GU toxicity. Conclusions: Our results suggest that adjuvant RT may offer a better biochemical outcome in patients who underwent radical prostatectomy for prostate cancer. Overall, the number of high grade toxicities for postoperative RT was low. Therefore it can safely be used in appropriate setting. No significant financial relationships to disclose.

Virtual HDR SBRT for localized prostate carcinoma: Efficacy and quality-of-life assessment.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 45-45 ◽  
Author(s):  
Donald B. Fuller ◽  
Reza Shirazi ◽  
John Naitoh ◽  
George Mardirossian
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Disease Free Survival ◽  
Life Assessment ◽  
Intermediate Risk ◽  
Gu Toxicity ◽  
Gi Toxicity ◽  
Grade 3

45 Background: We designed a CyberKnife (CK) prostate Stereotactic Body Radiotherapy (SBRT) method to recapitulate HDR fractionation and target volume coverage (“Virtual HDR”). We report 4 year efficacy, toxicity and quality of life (QoL) outcomes. Methods: Eligible patients had low- (Gleason < 6, PSA < 10 ng/mL, < T2bN0) or intermediate-risk (Gleason < 6 with PSA 10.01 – 20 ng/mL or Gleason 7 with PSA < 10 ng/mL, < T2bN0) prostate cancer. A dose of 38 Gy/4 fractions was given to > 95% of the PTV; with “HDR-like” bladder, urethral and rectal dose constraints, and “HDR-like” dose escalation in the PTV. Toxicities were assessed using CTCAE3.0 criteria. QoL was assessed using the Expanded Prostate Cancer Index Composite (EPIC). Results: Since July 2006, 59 patients were treated. Two were lost to follow-up and 6 have been followed < 6 months, leaving 51 (32 low- and 19 intermediate-risk) patients for analysis. Median f/u is 42 months (range, 6-60). 4-year actuarial biochemical-disease free survival is 98% (ASTRO, Phoenix). Freedom from local and distant relapse is 100% and 98%. Median baseline PSA of 6.3 ng/mL (range 1.0 – 14.1) decreased to 0.1 ng/mL by 48 months. Acute grade 2 GU and GI toxicity rates were 22% and 4%, respectively (0% Grade 3+). Three (6%) late Grade 3 GU toxicities occurred at 18, 48 and 48 months. No grade 3+ GI toxicity occurred. Late grade 2 GU and GI toxicity rates were 18% and 2%, respectively. Only 2 patients (4%) had ongoing late > grade 2 GU toxicity at last follow-up (0% GI). Mean EPIC urinary and bowel scores decreased at 2 months, with subsequent improvement and stability to 48 months. Mean EPIC sexual scores gradually declined to 48 months. Of patients potent at baseline, 63% were potent at 3 years, including 100% < age 60, 64% age 61-70 and 60% > age 70. Conclusions: To 4 years, HDR-like CK SBRT for low- and intermediate-risk prostate cancer results in a very low PSA nadir and relapse rate, minimal toxicity and a favorable QoL outcome, with an age-dependent potency preservation rate. The occasional occurrence of late grade 3 urethral stricture can likely be reduced by better patient selection (caution re: patients with significant pre-existing uropathy). Acute and late grade 2 GU toxicity usually resolves with conservative management.

Prostate hypofractionated radiotherapy (62Gy at 3.1Gy per fraction) with injection of hyaluronic acid: final results of the RPAH1 study

2021 ◽  
Vol 94 (1124) ◽  
pp. 20210242
Author(s):  
Olivier Chapet ◽  
Corina Udrescu ◽  
Sylvie Bin ◽  
Evelyne Decullier ◽  
Pascal Fenoglietto ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Hyaluronic Acid ◽  
Rectal Bleeding ◽  
Specific Antigen ◽  
Hypofractionated Radiotherapy ◽  
Gu Toxicity ◽  
Risk Prostate Cancer ◽  
Gi Toxicity ◽  
Grade 3

Objectives: The present multicenter Phase II study evaluated the rate of late grade ≥2 gastrointestinal (GI) toxicities at 3 years, after hypofractionated radiotherapy (HFR) of prostate cancer with injection of hyaluronic acid (HA) between the prostate and the rectum. Methods: Between 2010 and 2013, 36 patients with low- or intermediate-risk prostate cancer were treated by HFR/IMRT-IGRT. 20 fractions of 3.1 Gy were delivered, 5 days per week for a total dose of 62 Gy. A transperineal injection of 10cc of HA was performed between the rectum and the prostate. Late toxicities were evaluated between 3 and 36 months after the end of treatment (CTCAE v4). Results: Median pretreatment prostate-specific antigen was 8 ng ml−1. Among the 36 included patients, 2 were not evaluated because they withdrew the study in the first 3 months of follow-up, and 4 withdrew between 3 and 36 months, the per protocol population was therefore composed. Late grade ≥2 GI toxicities occurred in 4 (12%) patients with 3 (9%) Grade 2 rectal bleedings and one diarrhoea. Therefore, the inefficacy hypothesis following Fleming one-stage design cannot be rejected. None of the patients experienced late Grade 3–4 toxicities. Among the 30 patients completing the 36 months’ visit, none still had a grade ≥2 GI toxicity. Late grade ≥2 genitourinary (GU) toxicities occurred in 14 (41%) patients. The most frequent toxicities were dysuria and pollakiuria. Four patients still experienced a grade ≥2 GU toxicity at 36 months. The biochemical relapse rate (nadir +2 ng ml−1) was 6% (2 patients). Overall, HA was very well tolerated with no pain or discomfort. Conclusion: Despite the inefficacy of HA injection was not rejected, we observed the absence of Grade 3 or 4 rectal toxicity as well as a rate of Grade 2 rectal bleeding below 10% at 36 months of follow-up. Late urinary toxicities are the most frequent but the rate decreases largely at 3 years. Advances in knowledge: With an injection of HA, hypofractionated irradiation in 4 weeks is well tolerated with no Grade 3 or 4 GI toxicity and a rate of Grade 2 rectal bleeding below 10% at 36 months of follow-up.

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