Late toxicity and quality of life with prostate only or whole pelvic radiation therapy in high risk prostate cancer (POP-RT): A randomised trial

2020 ◽  
Vol 145 ◽  
pp. 71-80 ◽  
Author(s):  
Vedang Murthy ◽  
Priyamvada Maitre ◽  
Jatin Bhatia ◽  
Sadhana Kannan ◽  
Rahul Krishnatry ◽  
...  
2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 264-264 ◽  
Author(s):  
Hima Bindu Musunuru ◽  
Laura D'Alimonte ◽  
Melanie Davidson ◽  
Ling Ho ◽  
Patrick Cheung ◽  
...  

264 Background: Dose escalation using five-fraction stereotactic ablative radiotherapy (SABR) is gaining popularity in the treatment of prostate cancer. This has not been extensively tested in the context of pelvic radiation for high-risk groups. The objectives of study are to report early toxicity and quality of life outcomes in patients following 5-fraction prostate and pelvic radiation. Methods: A phase I/II study was performed where high-risk prostate cancer patients (T3a-3b or Gleason score ≥ 8 or PSA > 20ng/ml) received 40Gy to prostate and 25Gy to pelvis and seminal vesicles in 5 weekly fractions, on a gantry-based platform. A 3mm planning target volume margin to the prostate and a 6mm margin to the lymph nodes was applied. Image guidance was performed using gold seed fiducials and cone beam computerized tomography. Androgen deprivation therapy (ADT) was used for 12-18 months. Common Terminology Criteria for Adverse Events version 3.0 was used to assess toxicities at 3- and 6-months. Quality of life data (QOL) was captured using EPIC questionnaire. A minimally clinically important change (MCIC) definition was triggered if the EPIC QOL score decreases > 0.5 SD, where SD is the standard deviation of baseline scores. Results: Thirty patients completed the planned treatment with a median follow up of 11.9 months (IQR 8.3, 13.0). The following toxicities were observed: grade 2 genitourinary (GU): 50% at 3 months and 34.5% at 6 months; grade 2 gastrointestinal (GI): 3.3% at 3months and 6.9% at 6 months. No ≥ grade 3 toxicities were observed. Mean (95% Confidence Interval) EPIC urinary QOL scores were 86.6 (81.9-91.3), 87.1(81.4-92.6) and 86.1(80.2-92.0) at baseline, 3 months and 6 months and the bowel scores were 94.1(91.3-97.0), 93.2(89.1-97.2) and 93.2(89.5-96.8), respectively. Proportion of patients experiencing MCIC at 3 months and 6 months were 27.8% and 31.8% for urinary domain, 23.5% and 28.6% for bowel domain; respectively. Conclusions: This gantry-based novel fractionation schedule incorporating pelvic radiation for high-risk prostate cancer in combination with ADT is feasible and well tolerated in the acute setting. Clinical trial information: NCT 01953055.


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.


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]


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