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.

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.

scholarly journals Image Guided Hypofractionated Radiotherapy by Helical Tomotherapy for Prostate Carcinoma: Toxicity and Impact on Nadir PSA

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Salvina Barra ◽  
Stefano Vagge ◽  
Michela Marcenaro ◽  
Gladys Blandino ◽  
Giorgia Timon ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Helical Tomotherapy ◽  
Late Toxicity ◽  
Conformal Radiotherapy ◽  
Conventional Fractionation ◽  
Gu Toxicity ◽  
Gi Toxicity ◽  
Low Toxicity ◽  
Primary Radiotherapy

Aim. To evaluate the toxicity of a hypofractionated schedule for primary radiotherapy (RT) of prostate cancer as well as the value of the nadir PSA (nPSA) and time to nadir PSA (tnPSA) as surrogate efficacy of treatment.Material and Methods. Eighty patients underwent hypofractionated schedule by Helical Tomotherapy (HT). A dose of 70.2 Gy was administered in 27 daily fractions of 2.6 Gy. Acute and late toxicities were graded on the RTOG/EORTC scales. The nPSA and the tnPSA for patients treated with exclusive RT were compared to an equal cohort of 20 patients treated with conventional fractionation and standard conformal radiotherapy.Results. Most of patients (83%) did not develop acute gastrointestinal (GI) toxicity and 50% did not present genitourinary (GU) toxicity. After a median follow-up of 36 months only grade 1 of GU and GI was reported in 6 and 3 patients as late toxicity. Average tnPSA was 30 months. The median value of nPSA after exclusive RT with HT was 0.28 ng/mL and was significantly lower than the median nPSA (0.67 ng/mL) of the conventionally treated cohort (P=0.02).Conclusions. Hypofractionated RT schedule with HT for prostate cancer treatment reports very low toxicity and reaches a low level of nPSA that might correlate with good outcomes.

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.

A phase II study of neoadjuvant chemotherapy with docetaxel and bevacizumab in patients (pts) with high-risk localized prostate cancer: A Prostate Cancer Clinical Trials Consortium trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5060-5060
Author(s):  
W. K. Oh ◽  
P. G. Febbo ◽  
J. P. Richie ◽  
F. M. Fennessy ◽  
G. Scibelli ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Radical Prostatectomy ◽  
Phase Ii ◽  
Tumor Volume ◽  
Clinical Stage ◽  
Treatment Options ◽  
Localized Prostate Cancer ◽  
Rectal Injury ◽  
Grade 3

5060 Background: Treatment options for high-risk localized prostate cancer remain inadequate, with the majority of pts relapsing despite surgery or radiation therapy. We conducted a phase II multicenter trial of neoadjuvant docetaxel and bevacizumab prior to radical prostatectomy in pts with high risk localized prostate cancer. Methods: Eligibility included any of the following: PSA > 20 ng/ml or PSA velocity > 2 ng/ml/yr, cT3 disease, any biopsy Gleason 8–10, Gleason 7 with T3 disease by endorectal (er) MRI. Also, >50% biopsy cores involved and either Gleason 7 or PSA >10 or cT2 disease were eligible. Pts were treated with docetaxel 70 mg/m2 q 3weeks x 6 cycles and bevacizumab 15 mg/m2 q 3 weeks x 5 cycles. The primary endpoint was erMRI partial response (PR, defined here as >50% decrease in tumor volume) in a single target lesion after chemotherapy. Results: 42 pts were registered and treated with 220 cycles so far. Median age was 55 yrs (range 41–67). Median Gleason score was 8 (69% with Gleason 8–10 cancer). Median PSA was 10.5 ng/ml (range 2.1–72.5). Clinical stage was T2 in 46% and T3 in 32%. Of 23 evaluable pts to date, the median decline in the maximal tumor volume by erMRI was -45% (range -84% to 110%). 9/23 (39%) patients had PR, and only 1 pt had radiographic progression. Any PSA decline was noted in 22/34 (65%) evaluable pts, with 18% having a >50% decline. Treatment was well-tolerated: 2 pts had grade 3 allergic reactions requiring discontinuation, 3 had febrile neutropenia and 1 had grade 3 hyperglycemia. Mild fatigue was common. Only 1 pt stopped treatment because of a rising PSA. To date, 31 pts have had radical prostatectomy. One had intraoperative bladder neck injury and was treated instead with radiation + hormone therapy. A second pt had an intraoperative rectal injury but completed surgery. Conclusions: Neoadjuvant docetaxel and bevacizumab demonstrates clinical evidence of activity in men with high-risk localized prostate cancer, with a 39% PR rate by erMRI and PSA declines noted in 65%. Treatment was well-tolerated. The study is ongoing and updated data on response, toxicity and pathology will be presented. [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.

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.

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.

The impact of simultaneous dose escalation VMAT to the focal lesion micro boost of localized prostate cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e16592-e16592
Author(s):  
Radwa Fawzy Saleh Ahmed ◽  
Raafat Ragaie Abdel Malek ◽  
Mohamed Metwaly ◽  
Omar Abdel Aziz ◽  
Samy Al sirafy ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Dose Escalation ◽  
Localized Prostate Cancer ◽  
Focal Lesion ◽  
Rectal Toxicity ◽  
Gu Toxicity ◽  
Gi Toxicity

e16592 Background: Dose Escalation to the prostate is showing promising results of increasing local control. The study aims to assess biochemical failure free survival (BFF) after dose escalation to the prostate 78Gy with simultaneous integrated boost (SIB) 87Gy to the focal lesion. Genito-urinary (GU) & gastro-intestinal (GI) toxicity was assessed by comparing investigational toxicity score & patient outcome reports. Methods: Thirty intermediate & high risk localized prostate cancer patients were treated with dose escalated VMAT protocol of 78 Gy/35 fractions to prostate & 87Gy boost to focal lesion detected by baseline multi-parametric MRI & TRUS as well. Neo-adjuvant, Concurrent & adjuvant hormonal therapy was applied. Risk structures dose statistics were matched to modified Quantec with EQD2 equation. For each patient, daily online fiducial markers image guided verification was done. Toxicity profile was assessed by RTOG for subjective assessment and FACIT quality of life protocol for objective assessment during the radiotherapy course & follow up period. Results: About 80% of patients received the pre-determined protocol, however three patients received 76Gy to prostate & 84Gy to the focal lesion to comply with the risk structure constrains. At median follow up period of 18 months-BFF was 93.3 %. By the end of radiotherapy, 80% developed G3 GU toxicity while 30% developed G2 GI toxicity. Correlation between bladder V40 (≥or≤ 40%) & GU toxicity (≤ G3 vs G3) was of border line statistical significance (P = 0.05). After radiotherapy, GU toxicity dropped to 17.2% G2 & 13% G3 at the 3rd month while 0 % G3 afterwards. Three patients developed G4 rectal toxicity (bleeding per rectum); one at 9th month of ending treatment & two at 12th month; two of them needed cautery for angio-dysplasia as post radiation sequelae confirmed by colonoscopy. However, the correlation between V40 of the rectum ≥ 40% was significant with rectal toxicity (G0 vs G4) (P = 0.02). Comparing FACIT assessment during radiotherapy or in follow up showed no significant difference affecting the quality of life. Conclusions: Dose Escalation with SIB should be done using advanced technique like VMAT with image guidance. Re-validation of risk structure & rectal dose constrains should be considered especially for dose escalation ≥ 72Gy. Clinical trial information: NCT03384199.

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