scholarly journals Timing of High-Dose Rate Brachytherapy With External Beam Radiotherapy in Intermediate and High-Risk Localized Prostate CAncer (THEPCA) Patients and Its Effects on Toxicity and Quality of Life: Protocol of a Randomized Feasibility Trial

2015 ◽  
Vol 4 (2) ◽  
pp. e49 ◽  
Author(s):  
Sreekanth Palvai ◽  
Michael Harrison ◽  
Sharon Shibu Thomas ◽  
Karen Hayden ◽  
James Green ◽  
...  
2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 66-66
Author(s):  
G. Morton ◽  
D. A. Loblaw ◽  
H. T. Chung

66 Background: High dose rate (HDR) brachytherapy for prostate cancer is commonly given in multiple fractions combined with external beam radiotherapy (EBRT) over 5 weeks. We report results of a phase II clinical trial of single fraction HDR combined with hypofractionated EBRT over 3 weeks. Methods: Eligible patients had T1 or T2 carcinoma of the prostate with a PSA < 20 and Gleason score of 7 or less, without use of androgen deprivation. The trial accrued 125 patients with a median PSA of 6.8 ng/ml; 93% had Gleason 7. Single 15 Gy HDR was delivered to the prostate, followed 2-weeks later by EBRT to 37.5 Gy in 15 fractions. Patients were followed for toxicity (CTCAE v 3.0), health related quality of life (EPIC), urinary symptoms (IPSS), and clinical and biochemical control. Results: Median follow-up is 3 years (range: 1-4.5 years), with no biochemical failures. Median PSA at 3 years is 0.24 ng/ml. One of 38 biopsies at 2 years had persistent cancer. Two patients (1.6%) had acute grade 3 urinary toxicity, and median IPSS score returned to within 2 points of baseline by 3 months. The prevalence of grade 2 rectal and urinary toxicity at 2 years was 2% and 25%, respectively. Mean EPIC urinary and bowel domain scores decreased in the first 2 years, but returned to within 5 points of baseline at 3 years. Mean sexual function scores declined over the first 4 years although sexual bother scores returned to baseline at 3 years. On multivariate analysis, baseline IPSS score (p=0.0125), V100 (p=0.0002) and V200 (p=0.0141) were associated with acute grade 2 urinary toxicity. Decline in EPIC urinary quality of life domain was associated with HDR dose to 10% of urethra (p=0.0168), with a threshold of 120%. Decline in sexual scores was associated with smaller prostates and high baseline erectile functioning. Conclusions: Single fraction 15 Gy HDR combined with hypofractionated external beam radiotherapy is a well tolerated and effective treatment for intermediate risk prostate cancer. No significant financial relationships to disclose.


2021 ◽  
Vol 17 (2) ◽  
pp. 72-82
Author(s):  
V. A. Solodkiy ◽  
A. Yu. Pavlov ◽  
A. D. Tsibulskii ◽  
G. A. Panshin ◽  
A. G. Dzidzaria ◽  
...  

Background. Prostate cancer (PCa) in the Russian Federation takes the leading place in the prevalence of cancer among the male population.Objective: to investigate the effect of increasing a single focal dose in high-dose-rate brachytherapy (HDR-BT) in combination with external beam radiotherapy on biochemical failure-free survival and local control in patients with high-risk PCa. Materials and methods. The study included 350 men with PCa in the group of high and extremely high risk of progression. All patients included in the study were divided into 4 groups. Groups 1, 2 and 3 included 276 patients who received HDR-BT with a 192Ir source with a single dose per fraction: 10 Gy (n = 83), 12 Gy (n = 46) and 15 Gy (n = 147). Group 4 included 74 patients who received low-dose-rate brachytherapy with 125I sources up to a total focal dose of 110 Gy. At the 2 stage, external beam radiotherapy was a conventional fractionation (single dose of 2 Gy, total - 44-46 Gy).Results. Of 350 patients over a 5-year follow-up period, PCa recurrence was noted in 65 (18.6 %). The 3- and 5-year biochemical failure-free survival rates in the general cohort of patients were 87.4 and 81.4 %. 5-year biochemical failure-free survival was significantly higher in group 3 relative to group 4 and amounted to 89.8 and 74.2 % (p = 0.03). Increasing the dose for HDR-BT from 10 to 12 Gy per fraction significantly reduced the frequency of local relapses from 15.7 % (in group 1) to 2.2 % (in group 2) (p = 0.0001) while maintaining the level of genitourinary and gastrointestinal toxicity. Conclusion. The use of a combination of brachytherapy and external beam radiotherapy in patients with high risk PCa is highly effective in achieving local control of the tumor. The optimal fractionation regime for HDR-BT remains a matter of debate. The use of 15 Gy per fraction for HDR-BT in combination with external beam radiotherapy is the most optimal fractionation regimen in patients with high-risk PCa.


2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 236-236
Author(s):  
Imtiaz Ahmed ◽  
Sharon Shibu Thomas ◽  
Alexander Cain ◽  
Jufen Zhang ◽  
Sreekanth Palvai ◽  
...  

236 Background: Advances in brachytherapy, external beam radiotherapy (EBRT) and image-guided radiotherapy have revolutionized radiotherapy delivery. Acute and late genitourinary (GU) and gastrointestinal (GI) toxicities remain a significant issue. Currently there is no European consensus on the timing of high-dose rate (HDR) brachytherapy in relation to EBRT. Schedules of HDR boost before or after EBRT vary significantly between institutions.The incidence of GI and GU toxicities was assessed in patients receiving HDR brachytherapy before and after EBRT. Methods: Men with Intermediate/high risk localized prostate cancer were randomized to Arm A (HDR brachytherapy before EBRT) or Arm B (HDR brachytherapy after EBRT). Both arms received a HDR boost of 15Gy and 46Gy in 23 fractions of EBRT. All patients received neoadjuvant and adjuvant hormone therapy for up to 2 years. Patients were followed quarterly up to a year. CTCAE scores for GU and GI toxicities were taken. IPSS, IEFL and FACT-P scores were collected. Fisher’s exact test was used to analyze the association between GU and GI toxicities. The T-test compared the mean differences in IPSS total scores at each follow-up. Analysis of variance evaluated the difference at follow up. Post-hoc testing and Bonferroni correction was applied. Results: 100 patients were randomized between 2015 and 2017. Data for 88 patients was available at cutoff. Mean age was 69 years (SD: 4.6). Age, Gleason score, TNM and clinical staging were similar in each arm. Mean IPSS Score was similar between both arms at baseline Arm A (6.52) & Arm B (6.57). 12 months follow up showed mild worsening of symptoms in both arms, but no significant difference noticed between Arm A (8.02) & Arm B (8.14) p=0.55. At 12 months, Grade 1 and 2 GU toxicities were more frequent in Arm A (22.88% & 5.28%, p=0.669) compared to Arm B (19.36% and 2.64%, p=0.485). Grade 1 GI toxicity was more common in Arm B (23.76%) than Arm A (21.2%), p=0.396. Grade 2 GI toxicities were more common in Arm A 5.28% vs 3.52%, p=0.739. Baseline mean IIEF scores were 10.9 and 10.53 in Arm A and B respectively. At 12 months this was 6.6 in Arm A and 7.11 in Arm B, but not statistically significant. FACT-P scores were not different in either arm, with good QOL scores maintained throughout. Mean score at baseline (125.18) was observed to be similar at 12 months follow up at (126.10). The PTV, CTV & OAR dose were compared and no significant differences were found. Conclusions: There were no significant differences in GI and GU related toxicities up to a year between patients receiving HDR brachytherapy before or after EBRT. There were no grade 3 or 4 toxicities. Treatment was well tolerated in both arms with good QOL scores. Longer follow up and a phase III multicenter RCT would be needed to validate findings. Clinical trial information: NCT02618161.


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