Pelvic SABR with HDR boost in intermediate- and high-risk prostate cancer (SPARE): Favorable early toxicity and quality-of-life outcomes.

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]

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14587-14587
Author(s):  
B. Guix ◽  
T. M. Lacorte ◽  
F. Guedea

14587 Background: To elucidate long-term changes in health-related quality-of-life (HRQOL) outcomes by prospectively re-evaluating a cohort of intermediate- or high-risk prostate cancer patients treated by a combination of 3-D External Beam Radiotherapy (EBRT) and Brachytherapy (BT) with or without androgen deprivation (AD). Methods: A cross-sectional survey was administered to 200 consecutive patients with intermediate (Gleason 7 or PSA 10–20 or T2A-B) or high (Gleason >7 and/or PSA >20 and/or >T2B) - Risk Prostate cancer who were treated by EBRT to the prostate followed by BT to the prostate given either by permanent 125-I seeds (LDR) or high dose rate (HDR) implants before treatment and at 6 months interval during 4 years follow-up. The EORTC CLQ-C30 with the PR-25 module was employed. HRQOL was compared among therapy groups. Comparisons between therapy groups was performed using regression models to control covariates. HRQOL of treatment parameters were evaluated. Distribution of responses for bowel-, urinary- and sexual-related functions were analyzed. Results: 200 patients completed the questionnaires. Significant changes in HRQOL were found depending of the time after treatment. After a temporal decline in HRQOL, an improvement owas found during the first 18 months after end of treatment. Significant improvement in the urinary irritative-obstructive performance (p < 0.006) was found after 6 months post-treatment. Bowel domains worsened after therapies (p < 0,05) but improved after 18 months follow-up (p < 0.02). Overall sexual HRQOL deteriorated depending greatly on treatment (p < 0.008). Patients who were given AD presented a significant lower Sexual Function values, that were difficult to recover after AD cessation (p < 0.007). No differences in HRQOL were found between LDR or HDR BT implants. Satisfaction with either treatment was high. Conclusions: After a decline in HRQOL after treatment, it recovered fully during follow-up. In patients treated by AD, sexual function was the most adversely affected quality-of-life domain. Sexual impairment induced by AD was difficult to recover. These results may be of assistance to men and to clinicians when making treatment decisions, mainly relating AD. No significant financial relationships to disclose.


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]


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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