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

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 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.

HIGH-DOSE-RATE AND LOW-DOSE-RATE BRACHYTHERAPY AS MONOTHERAPY FOR CLINICALLY LOCALIZED PROSTATE CANCER

2019 ◽  
Vol 65 (3) ◽  
pp. 434-440
Author(s):  
Vladimir Solodkiy ◽  
Andrey Pavlov ◽  
Aleksey Tsybulskiy ◽  
Aleksandr Pchelintsev ◽  
Ivan Moshurov ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Dose Rate ◽  
Low Dose ◽  
Risk Groups ◽  
High Dose Rate ◽  
Localized Prostate Cancer ◽  
High Dose ◽  
Intermediate Risk ◽  
Psma Pet ◽  
Gu Toxicity

PURPOSE:To compare the outcome of high-dose-rate interstitial brachytherapy (HDR-BT) and low-dose-ratebrachytherapy (LDR-BT) as monotherapy for localized prostate cancer of low and intermediate risks progression. METHODS AND MATERIALS: The study included 165 patients with localized prostate cancer in low and intermediate progression risk groups. We compared 65 patients treated with HDR-BT and 100 patients with LDR-BT as monotherapy. LDR-BT treated advanced disease with more hormonal therapy than HDR-BT. All patients were in low and intermediate risk groups for prostate cancer progression. HDR-BT as monotherapy was delivered in 2 fractions of 15 Gy, two weeks apart. LDR-BT was performed in a standard mode of 145 Gy. The median observation was 32 months. All patients gave written informed consent. RESULTS: Overall biochemical free survival rate (BFSR) is 95,8%. There are 7 people having a growing prostatic specific antigen (PSA) while the case follow-up (in the group HDR-BT - 2 patients, LDR - 5 patients). Two recurrence cases with metastases in lymph nodes and bones were brought out as a result of 68Ga-PSMA PET examination in the group of HDR-BT. In 4 cases out of 5 LDR-BT, a local recurrence was detected (p=0,085). All cases of relapse were found in patients at intermediate risk (p = 0,041). LDR-BT showed a higher incidence of genitourinary (GU) toxicity grade >2 than that of HDR-BT in the acute phase and grade 1 toxicity in late phase. Accumulated incidence of late grade >2 GU and GU toxicity was equivalent between HDR-BT and LDR-BT. CONCLUSION: HDR-BT monotherapy showed an equivalent outcome to that of LDR-BT for low and intermediate risk patients. LDR-BT showed equivalent incidence of grade >2 late GU toxicities and higher grade >2 acute GU toxicity as that of HDR-BT as a monotherapy.

HDR brachytherapy combined with hypofractionated EBRT for intermediate-high risk prostate cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14655-14655
Author(s):  
T. Akimoto ◽  
K. Hiroyuki ◽  
K. Shirai ◽  
K. Harada ◽  
T. Ebara ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Median Time ◽  
Late Complication ◽  
Prostate Gland ◽  
Survival Rates ◽  
Hdr Brachytherapy ◽  
Androgen Ablation ◽  
Gu Toxicity ◽  
Grade 3

14655 Background: To report on biochemical outcome and late complication in pts with localized prostate cancer (LPC) treated with HDR-brachytherapy (HDR-BT) combined with hypofractionated EBRT. Methods: From 06/2000 to 12/2004, 108 pts with intermediate (37 pts.) or high-risk (63 pts.) LPC were treated with hypofractionated EBRT (3 Gy × 17 fr., thrice a week) followed by HDR-BT (5 Gy × 5; 9 pts, 7 Gy × 3; 15 pts, 9 Gy × 2; 76 pts). HDR-BT was administered a week after the completion of the hypofractionated EBRT. The planning target volume was defined as the prostate gland with a 5-mm margin all around, and the planning was conducted based on CT images. Biologically effective doses (BED) to the prostate was between 83–84 Gy. All patient received androgen ablation. Acute and late toxicities were scored according to the EORTC/RTOG morbidity grading scales. Median follow-up duration was 27 months from HDR-BT and 39 months from initiation of androgen ablation. Results: All pts completed treatment. The 5-year actuarial PSA relapse-free survival rates for intermediate and high-risk pts were 100% and 93% respectively. Acute genitourinary (GU) toxicity was 64% in grade 0–1, 31% in grade 2 and 6% in grade 3. Urethral stricture developed in 3%, with a median time from the completion of HDR brachytherapy to the occurrence of 22 months (19–26 months). Ten pts had grade 2 rectal bleeding, with a median time from the completion of HDR brachytherapy to the occurrence of 11 months (7–14 months). No pts developed grade 3 or more severe rectal complication. The incidence of acute and late toxicity did not differ according to the fractionation schema of HDR-BT. Conclusion: Our data demonstrate the successful feasibility of HDR-BT combined with hypofractionated EBRT as a safe method for escalating the total dose to the prostate without significant increasing risk of acute and late GU and rectal toxicities. No significant financial relationships to disclose.

Two-years biochemical failure-free survival following high intensity focused ultrasound (HIFU) for localized prostate cancer: Prospective single center study of 196 patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5117-5117
Author(s):  
J. H. Pinthus ◽  
F. Farrokhyar ◽  
M. M. Hassouna ◽  
E. Woods ◽  
W. L. Orovan
Keyword(s):  
Prostate Cancer ◽  
Focused Ultrasound ◽  
Oncological Outcome ◽  
Risk Groups ◽  
Biochemical Failure ◽  
High Intensity Focused Ultrasound ◽  
Localized Prostate Cancer ◽  
Available N ◽  
Psa Nadir ◽  
Pre Treatment

5117 Background: HIFU is an emerging ablative modality for the treatment of localized prostate cancer with limited reports on oncological outcome. We prospectively analyzed our 2-year results. Methods: 253 consecutive patients (age: 64+8) were treated with a planed single session of HIFU using the Ablatherm integrated imaging model system between January 2006 and June 2008. Patients were followed (median: 12; range 3–24 months) with PSA measurement every 3 months. Patients who received prior radiation or hormonal therapy (n=25) and patient for whom at least 2 consecutive PSA measurements were not available (n = 32) were excluded, leaving a total of 196 patients for analysis. Mean pre-treatment PSA was 6.9+3.3. Biopsy Gleason scores at diagnosis (median 9 cores) were 5, 6, 3+4, 4+3 in 1, 91, 66 and 38 patients, respectively. Biochemical failure (BCF) is reported using the Stephenson (PSA >0.4ng/ml and rising), Horwitz (2 consecutive increases of at least 0.5ng/ml) and Phoenix (nadir+2ng/ml) definitions. Results: 196 patients (age: 64+8) met the inclusion criteria for analysis. 75 had low and 121 had intermediate D'Amico's risk stratification disease. Mean and median absolute PSA nadir levels were 0.28+0.53 and 0.06 ng/ml respectively. It was achieved in median time of 3 months and remained unchanged in 70% of the patients throughout the follow-up. Overall 2 years BCF free rates were 70 % (62–78%), 86 % (81–91%) and 96% (91–99%) according to the Stephenson, Horwitz and Phoenix definitions, respectively; with no significant differences between risk groups. Predictors of BCF were absolute nadir [HR: 3.0 (2.3–3.8)] and pre-treatment PSA [HR: 1.1 (1.0–1.2)]. Conclusions: This is the only study to date that analyzed post HIFU BCF free rates according to post radical prostatectomy definition of BCF. BCF usually occur in the first year and plateau thereafter. Short term results by all BCF definitions are promising with similar results for patients with low and intermediate risk. Pre-HIFU PSA and post-HIFU PSA nadir levels are predictors for BCF. [Table: see text]

A randomized trial of 79.2Gy versus 70.2Gy radiation therapy (RT) for localized prostate cancer.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 4-4 ◽  
Author(s):  
Jeff M. Michalski ◽  
Jennifer Moughan ◽  
James Purdy ◽  
Walter Bosch ◽  
Jean-Paul Bahary ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Dose Escalation ◽  
Late Toxicity ◽  
Phase Iii ◽  
Localized Prostate Cancer ◽  
Rank Test ◽  
High Dose ◽  
Local Progression ◽  
Gu Toxicity ◽  
Grade 3

4 Background: RTOG 0126 is a phase III trial for localized prostate cancer (PC) testing whether dose escalation to 79.2Gy with 3DCRT or IMRT will improve overall survival (OS). Methods: Stage cT1b-T2b with Gleason Score (GS) 2-6 and PSA ≥ 10 and <20 or GS 7 and PSA <15 were eligible and randomized to receive 79.2Gy or 70.2Gy. No androgen withdrawal was used. Treatment was 3DCRT or IMRT to 79.2Gy in 44 fractions or 70.2Gy in 39 fractions. The objective was to detect a 23% reduction in mortality hazard (HR=0.77) for 79.2Gy. ASTRO and Phoenix definition was used for biochemical failure (BF). Time to local progression (LP), distant metastases (DM), PC death, and late GI/GU toxicity was calculated from date of registration. OS was estimated by Kaplan Meier and arms compared with log rank test. BF, LP, DM, time to late GI/GU, and PC death were estimated by cumulative incidence method and arms compared with Gray’s test. Results: 1,532 men were randomized, 763 to 79.2Gy and 769 to 70.2Gy. 1,499 were eligible, 751 and 748 in the 79.2Gy and 70.2Gy arms respectively. Median age was 69, 70% had PSA < 10 ng/ml, 84% with GS 7, 57% had T1 disease, and 66% used 3D-CRT. With a median of 7.0 years follow up, the 5 and 10-yr rates of OS are 88% and 67% with 79.2Gy and 89% and 66% with 70.2Gy (p=0.87; HR (95%CI)=0.98 (0.79,1.21)). The ASTRO (Phoenix) BF rates at 5 and 10 yr are 25% (16%) and 30% (26%) with 79.2Gy and 40% (21%) and 45% (43%) with 70.2Gy (both p<0.0001). The 5 and 10-yr rates of LP are 1% and 4% with 79.2Gy and 2% and 8% with 70.2Gy (p=0.0059; HR (95%CI)=0.46 (0.27,0.81)). The 5 and 10 yr rates of DM are 2% and 5% with 79.2Gy and 3% and 8% with 70.2Gy (p=0.026; HR (95%CI)=0.57 (0.35,0.94)). The high dose arm had lower rate of salvage therapy, 13.5% vs 21%, p=0.0002. The 10 yr rates for time to late grade ≥ 2 GI/GU are 22%/15% with 79.2Gy and 16%/10% with 70.2Gy (p=0.0063/p=0.001). Time to late grade ≥ 3 GI was higher for the 79.2Gy arm (p=0.035) but time to late grade ≥ 3 GU toxicity was not (p=0.14). Conclusions: Despite significant improvement in BF, DM, and LP rates, dose escalation did not improve OS. Patients receiving high dose radiation experience more late toxicity. Clinical trial information: NCT00033631.

High dose rate brachytherapy as monotherapy for localized prostate cancer: Our initial experience.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. e626-e626
Author(s):  
Amarnath Challapalli ◽  
Susan Masson ◽  
Pauline Humphrey ◽  
Frances Bamisaye ◽  
Petra Jacobs ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Dose Rate ◽  
Transrectal Ultrasound ◽  
Target Volume ◽  
High Dose Rate ◽  
Localized Prostate Cancer ◽  
High Dose ◽  
Initial Experience ◽  
Grade 3

e626 Background: High dose rate (HDR) brachytherapy is an attractive treatment option for localized prostate cancer (CaP) as it allows for safe dose escalation and exploits the radiobiological advantage of using a high dose/fraction. We evaluate our early experience in using HDR monotherapy for localized CaP. Methods: Forty patients with low- to intermediate-risk CaP were treated from October 2013-July 2015. Patients had catheters placed transperineally under spinal anaesthesia, using transrectal ultrasound guidance. The clinical target volume [CTV: prostate ± seminal vesicles base] was outlined on a planning CT scan with the catheters and template in-situ. The CTV was grown by 3mm isotropically to obtain the planning target volume (PTV). The catheters were reconstructed and plan optimised according to pre-set dose constraints [DC]. Dose delivered was 19Gy/one fraction. Toxicity was assessed using RTOG criteria. Results: A range of volumes were implanted (20–120 cc, median: 37.5), using a median of 17 needles (range 13–20). Satisfactory implants were achieved in patients with volumes>60cc by excluding pubic arch interference on the pre-implant MRI pelvis. All patients were discharged home within 24 hours, with two patients (5%) requiring re-catheterisation. Good dose coverage to the PTV was achieved: median D90 of 20.4Gy (DC>19Gy), V100 of 95.1% (DC≥95%). Urethral and rectal sparing was satisfactory: urethral D10 of 21.23Gy (DC<22Gy), rectal D2cc of 14Gy (DC<15Gy). The median follow-up was 8 (1-22.6) months. Twenty-five patients, with at least 6 months follow-up showed a median PSA reduction of 80%. Thus far, one had biopsy proven recurrence. Only two patients had grade 3 urinary toxicity and one had grade 3 bowel toxicity at 2 weeks, which returned to baseline at 12 weeks. The IPSS score increased at 2-4 weeks after treatment, but returned to baseline after 3 months. Conclusions: Our initial experience with HDR monotherapy for localized CaP confirms this to be safe, with minimal acute complications. It is possible to implant volumes higher than 60cc, if adequate measures are taken. The early efficacy data for 19Gy is also promising.

Late toxicity and quality of life from GETUG-AFU 22 study.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 331-331
Author(s):  
Igor Latorzeff ◽  
Stephane Guerif ◽  
Sandra Pelissier ◽  
Emmanuel Meyer ◽  
Julien Fraisse ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Late Toxicity ◽  
Localized Prostate Cancer ◽  
Efficacy Analysis ◽  
Prostate Bed ◽  
Gu Toxicity ◽  
Significant Difference ◽  
Grade 3

331 Background: Radical prostatectomy (RP) is recommended as a standard treatment for localized prostate cancer. However no recommendations exist for pts with immediate detectable PSA after RP. Methods: Pts with localized prostate cancer, treated by RP (R0 or R1), with a PSA level post-RP ≥0.2 ng/mL and ≤2 ng/mL at randomization and N0 M0 on imaging were included. Pts were randomized (1:1) to radiotherapy (RT) alone (RT arm) or 6 months degarelix hormone therapy (HT) with RT (RT+HT arm). RT consisted of pelvic irradiation (46 Gy in 23 Fr) with a boost on the prostate bed (66 Gy in 33 Fr). The primary endpoint was event-free survival (EFS). Acute and late toxicities were evaluated as secondary endpoints and scored using CTCAE V4.0 scale. Quality of life (QOL) was assessed with QLQ-C30 and QLQ-PR25 questionnaires at 12 and 24 months. Late toxicity was reported at 24 months. Results: From Jan-2013 to Sept-2015, 125 pts were included (RT arm: 64 pts; RT+HT arm: 61). Median follow up is 38 months (31.4; 44). The baseline characteristics are well-balanced between two arms: median age was 66 yrs (50-77), all men having an ECOG ≤1 (ECOG 0 in 92%), a median Gleason score of 7 (3-9), a median PSA of 0.3 ng/mL (0.09-1.82) post-RP and 0.6 ng/mL (0.12-3.65) at randomization. All pts received 33 Fr of RT. In the RT+HT arm 98.4% of pts received the 6 months of HT planned. All pts were eligible for safety analysis. At 24 months, no difference in late genitourinary (GU) or gastrointestinal (GI)toxicity was observed between the two arms (p=0.145) Grade 3 late toxicities were reported for 15/125 pts (12%): 8/64 pts (6.5%) in the RT arm and 7/61 pts (5.5%) in RT+HT arm (NS) and no toxicity grade >3 was observed. Evaluation of QOL was assessable at 12 and 24 months of FU for 80%/89% pts and 59%/77% pts in RT/RT-HT arms respectively. At 12 months QLQ-PR25 HT related symptoms was significantly more important in the RT-HT arm (p=0.04). At 24 months no significant difference in QLQC-30 or QLQ-PR25 analysis was reported. Conclusions:, At 24 months in this phase II trial no significant difference in GI/GU toxicity and.QOL was observed between the two arms. GETUG-AFU 22 efficacy analysis is still pending. Clinical trial information: NCT01994239.

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.

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