Stereotactic pelvic radiotherapy with HDR boost for dose escalation in intermediate and high-risk prostate cancer (SPARE): Efficacy, survival, and late toxicity outcomes.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 328-328
Author(s):  
Andrew Loblaw ◽  
Bindu Musunuru ◽  
Patrick Cheung ◽  
Danny Vesprini ◽  
Stanley K. Liu ◽  
...  

328 Background: The ASCO/CCO guidelines recommend brachytherapy boost for all eligible intermediate- or high-risk localized prostate cancer patients. We present efficacy, survival and late toxicity outcomes in patients treated on a prospective, single institutional protocol of MRI dose painted HDR brachytherapy boost (HDR-BT) followed by pelvic stereotactic body radiotherapy (SBRT) and androgen deprivation therapy (ADT). Methods: A phase I/II study was performed where intermediate (IR) or high-risk (HR) prostate cancer patients received HDR-BT 15Gy x 1 to the prostate and up to 22.5Gy to the MRI nodule and followed by gantry-based SBRT 25Gy in 5 weekly fractions delivered to pelvis, seminal vesicles and prostate. ADT was used for 6-18 months. CTCAEv3 was used to assess toxicities and was captured q6months x 5 years. Biochemical failure (BF; nadir + 2 definition), nadir PSA, proportion of patients with PSA < 0.4 ng/ml at 4 years (4yPSARR), incidence of salvage therapy, cause specific survival and overall survival were calculated. Day 0 was HDR-BT date for all time-to-event analyses. Results: Thirty-two patients (NCCN 3% favorable IR, 47% unfavorable IR and 50% HR) completed the planned treatment with a median follow-up of 50 months; 31 of these had an MRI nodule. Four patients had BF with actuarial 4-year BF rate of 11.5%; 3 of these received salvage ADT. Median nPSA was 0.02 ng/ml; 4yPSARR was 68.8%. One patient died (of prostate cancer) at 45 months. For late toxicities, grade 1, 2 and 3+ GU and GI toxicities were: 40.6%, 37.5%, 3% and 28.1%, 0%, 0%, respectively. Conclusions: This novel treatment protocol incorporating MRI-dose painted HDR brachytherapy boost and SBRT pelvic radiation for intermediate- and high-risk prostate cancer in combination with ADT is feasible, effective and well tolerated. Clinical trial information: 12345678. [Table: see text]

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 60-60 ◽  
Author(s):  
Hima Bindu Musunuru ◽  
Andrea Deabreu ◽  
Melanie Davidson ◽  
Ananth Ravi ◽  
Joelle Antoine Helou ◽  
...  

60 Background: ASCENDE-RT has provided level 1 evidence supporting the use of androgen deprivation therapy (ADT), external beam radiotherapy and brachytherapy boost in intermediate- and high-risk prostate cancer. The objectives of this study are to report early toxicity and quality of life (QOL) outcomes in patients treated on a hybrid protocol using five-fraction pelvic stereotactic ablative radiotherapy (SABR) with a MRI dose painted HDR brachytherapy boost (HDR-BT). Methods: A phase I/II study was performed where intermediate (IR) and high-risk (HR) prostate cancer patients received HDR-BT 15Gy in single fraction to the prostate and up to 22.5Gy to the MRI nodule. Gantry-based 25Gy SABR was delivered to pelvis, seminal vesicles and prostate in 5 weekly fractions. ADT was used for 6-18 months. Common Terminology Criteria for Adverse Events version 3.0 was used to assess toxicities. QOL was captured using EPIC at every follow-up. A minimally clinically important change (MCIC) definition was triggered if the EPIC QOL score at each time point decreases > 0.5 SD, where SD is the standard deviation of baseline scores. Results: Thirty-three patients (NCCN 6.0% low IR, 45.5% high IR and 48.5% HR) completed this treatment with a median follow-up of 13.8 months (IQR 12.1, 18.8). The incidence of worst toxicities is shown in Table 1.The 3 grade 3 GU patients were due to temporary urinary catheterization in the acute period following HDR-BT. Mean (95% SD) EPIC urinary QOL scores were 82.5 (16.5), 83.2 (12.9) and 83.7 (16.3) at baseline, 3 months and 12 months and the bowel scores were 95.9 (3.8), 92.6 (8.2) and 90.5 (8.3), respectively. Proportion of patients experiencing MCIC at 3 months and 12 months were 20.8% and 14.3% for urinary domain, 47.8% and 53.9% for bowel domain; respectively (see Table). Conclusions: This novel treatment protocol incorporating MRI dose painted HDR brachytherapy boost and SABR pelvic radiation for intermediate- and high-risk prostate cancer in combination with ADT is feasible and well tolerated in the acute setting. Clinical trial information: REB 269-2014. [Table: see text]


2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 47-47
Author(s):  
Sergio Faria ◽  
Russel RUO ◽  
Fabio Cury ◽  
Marie Duclos ◽  
Luis Souhami

47 Background: Two recent large randomized trials confirm that 60Gy in 20 fractions is an effective regimen compared to conventionally fractionated escalated doses in localized prostate cancer. However, in these two trials the prostate was the only target volume irradiated. The purpose of this study is to report acute and late toxicity in patients with high-risk prostate cancer treated with the same moderate hypofractionated radiotherapy (HypoRT) to two target volumes at the same time: prostate and pelvic nodes. Methods: High-risk prostate cancer patients received 60Gy/20 fractions (4 weeks) to the prostate while the pelvic-nodes received 44Gy delivered with intensity modulated radiation therapy (IMRT) with a simultaneous integrated boost (SIB) during the same 20 fractions. ADT started 2-3 months before HypoRT. Acute and late toxicity were prospectively assessed according to CTCAE.v3. Results: 105 patients treated between September/2010 and November/2013 were reviewed. Median follow up is 41 months. Median ADT duration was 18 months. Acute grade > 2 gastrointestinal (GI) or genitourinary (GU) toxicity was seen in 17% and 17% respectively, with only 1 and 3 patients experiencing GI and GU acute grade 3 toxicity, respectively. The worst grade > 2 late GI and GU toxicity was seen in 7% and 8% of patients, respectively. There was no grade 4-5 toxicity. At the last follow-up, the rates of grade = 2 GI and GU toxicity were 5% and 3%, respectively with no residual grade > 3 toxicity. The 48-month actuarial progression free survival is 82%. We found only 8 publications on this topic, all delivered the HypoRT in 25-28 fractions, but only one has long-term toxicity. Conclusions: ADT with HypoRT delivered with IMRT and SIB to the prostate (60Gy) and pelvic nodes (44Gy) in 20 fractions is feasible and well tolerated after 41months of median follow-up. Our approach shortens treatment duration, is convenient and its results support a needed randomized trial. Clinical trial information: NCT02107287.


2015 ◽  
Vol 22 (2) ◽  
pp. 76 ◽  
Author(s):  
C.S. Drodge ◽  
O. Boychak ◽  
S. Patel ◽  
N. Usmani ◽  
J. Amanie ◽  
...  

BackgroundDose-escalated hypofractionated radiotherapy (hfrt) using intensity-modulated radiotherapy (imrt), with inclusion of the pelvic lymph nodes (plns), plus androgen suppression therapy (ast) in high-risk prostate cancer patients should improve patient outcomes, but acute toxicity could limit its feasibility.MethodsOur single-centre phase ii prospective study enrolled 40 high-risk prostate cancer patients. All patients received hfrt using imrt with daily megavoltagecomputed tomography imaging guidance, with 95% of planning target volumes (ptv68 and ptv50) receiving 68 Gy and 50 Gy (respectively) in 25 daily fractions. The boost volume was targeted to the involved plns and the prostate (minus the urethra plus 3 mm and minus 3 mm from adjacent rectal wall) and totalled up to 75 Gy in 25 fractions. Acute toxicity scores were recorded weekly during and 3 months after radiotherapy (rt) administration.ResultsFor the 37 patients who completed rt and the 3-month follow-up, median age was 65.5 years (range: 50–76 years). Disease was organ-confined (T1c–T2c) in 23 patients (62.1%), and node-positive in 5 patients (13.5%). All patients received long-term ast. Maximum acute genitourinary (gu) and gastrointestinal (gi) toxicity peaked at grade 2 in 6 of 36 evaluated patients (16.6%) and in 4 of 31 evaluated patients (12.9%) respectively. Diarrhea and urinary frequency were the chief complaints. Dose–volume parameters demonstrated no correlation with toxicity. The ptv treatment objectives were met in 36 of the 37 patients.ConclusionsThis hfrt dose-escalation trial in high-risk prostate cancer has demonstrated the feasibility of administering 75 Gy in 25 fractions with minimal acute gi and gu toxicities. Further follow-up will report late toxicities and outcomes.


2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 112-112
Author(s):  
Claire Arthur ◽  
Nooreen Sarah Alam ◽  
Paula Mandall ◽  
Ric Swindell ◽  
P. Anthony Elliott ◽  
...  

112 Background: Single-fraction HDR brachytherapy offers a highly conformal approach to dose escalation for intermediate and high risk prostate cancer and exploits the apparent low α/β ratio of prostate cancer cells. The potential benefit of improving tumour control must be balanced against the heightened risk of toxicity. We assessed and compared toxicity among patients receiving either 12.5 Gy or 15 Gy as a single fraction HDR boost prior to conformal external beam radiotherapy (EBRT). Methods: Between July 2008 and February 2011, 177 patients received HDR brachytherapy prior to conformal EBRT (37.5 Gy in 15 fractions). 95 patients in the early cohort received 12.5 Gy and 82 patients in the later cohort received 15 Gy. The median patient age at presentation was 67 (range 57 – 77) with a median PSA of 16.0 (range 0.29 – 102), median Gleason score 7 (range 6 – 10), clinical stages T1c to T4 and median baseline IPSS was 8 (range 0 – 27). Prospective patient questionnaires - IPSS, LENT SOMA and EPIC QoL - were completed prior to treatment and at regular intervals following EBRT (6 weeks, 6 monthly thereafter). Results: Both treatment groups had similar median IPSS values at 6 weeks (12.5 Gy = 10, 15 Gy = 11); there was no significant difference in values throughout follow-up. Mean LENT SOMA scores for bladder/urethra toxicity peaked at 6 weeks (12.5 Gy = 0.6, 15 Gy = 0.72) with no trend towards greater reporting of maximum values of ≥ 2 in the 15 Gy cohort. Rectum/bowel mean LENT SOMA scores peaked at 6 weeks (12.5 Gy = 0.30, 15 Gy = 0.39). Although a greater proportion of 15 Gy patients reported a maximum score of ≥ 2 at 6 weeks and 6 months compared with the 12.5 Gy patients, this returned to pre-treatment levels at 12 months. Conclusions: We conclude that dose escalation from 12.5 Gy to 15 Gy delivered in a single HDR fraction is not associated with a clinically significant increase in toxicity. We believe that the reported toxicity is acceptable at this level of dose escalation (2 Gy equivalent = 112 Gy, assuming an α/β ratio of 1.5). Ongoing follow-up is required to ascertain tumour control.


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