Stereotactic body radiotherapy (SBRT) versus conventional fractionated intensity-modulated radiotherapy (CF-IMRT) for Asian patients with early-stage localized prostate cancer: Acute toxicity results from a prospective randomized phase II study

27 Background: It remains uncertain whether stereotactic body radiotherapy (SBRT) is superior to conventional fractionated intensity-modulated radiotherapy (CF-IMRT) in the treatment of early-stage prostate cancer. Here we report the 1-year late toxicity results from this randomized phase II study comparing SBRT and CF-IMRT. Methods: The primary endpoint of this single centre randomized phase II study is the health-related quality of life (HRQOL), as measured by the bowel and urinary domains of the Expanded Prostate Cancer Index Composite (EPIC) instrument. The secondary endpoints include toxicities, biochemical control and overall survival. We enrolled low and intermediate risk localized prostate cancer patients (T1-T2, Gleason score ≤7 and PSA <20). Patients were randomly assigned in a 1:1 ratio to receive either CF-IMRT with 38 fractions of 2 Gy in 7.5 weeks (five fractions per week) or SBRT with 5 fractions of 7.25 Gy in 2 weeks (three fractions per week). Neoadjuvant androgen-deprivation treatment is optional for the intermediate risk patients. A 1-year late adverse event is defined as the first occurrence of worst severity of the adverse event within 1 year after the completion of RT, and it was evaluated with the Common Terminology Criteria for Adverse Events (version 4.0). Patient recruitment was completed in May 2017. Results: Between Jan 2015 and May 2017, 68 patients were recruited and 4 patients were not eligible. 64 patients were randomized to treatments with SBRT (n=31) or CF-IMRT (n=33). At 1- year follow-up, two grade 3 genitourinary (GU) late toxicities, one in each arm (3%), were reported. SBRT patients experienced significantly less ≥ grade 1 late gastrointestinal (GI) toxicities (SBRT vs IMRT: 64% vs 84%, p=0.041) and similar ≥grade 1 late GU toxicities (SBRT vs IMRT: 93% vs 100%, p=0.2307) to IMRT patients. Conclusions: SBRT results in significantly less 1-year late GI toxicities than CF-IMRT in with low and intermediate risk prostate cancer. The study is registered at ClinicalTrials.gov (NCT02339701). Clinical trial information: NCT02339701.

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Phase II study of stereotactic body radiotherapy with hydrogel spacer for prostate cancer: acute toxicity and propensity score-matched comparison

Radiation Oncology ◽

10.1186/s13014-021-01834-1 ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

Mami Ogita ◽

Hideomi Yamashita ◽

Yuki Nozawa ◽

Sho Ozaki ◽

Subaru Sawayanagi ◽

...

Keyword(s):

Prostate Cancer ◽

Propensity Score ◽

Acute Toxicity ◽

Phase Ii ◽

Stereotactic Body Radiotherapy ◽

Phase Ii Study ◽

Summary Score ◽

Trial Registration ◽

Gu Toxicity ◽

Patient Reported

Abstract Background The efficacy of a hydrogel spacer in stereotactic body radiotherapy (SBRT) has not been clarified. We evaluated the safety and efficacy of SBRT in combination with a hydrogel spacer for prostate cancer. Methods This is a prospective single-center, single-arm phase II study. Prostate cancer patients without lymph node or distant metastasis were eligible. All patients received a hydrogel spacer insertion, followed by SBRT of 36.25 Gy in 5 fractions with volumetric modulated arc therapy. The primary endpoint was physician-assessed acute gastrointestinal (GI) toxicity within 3 months. The secondary endpoints were physician-assessed acute genitourinary (GU) toxicity, patient-reported outcomes evaluated by the EPIC and FACT-P questionnaires, and dosimetric comparison. We used propensity score-matched analyses to compare patients with the hydrogel spacer with those without the spacer. The historical data of the control without a hydrogel spacer was obtained from our hospital’s electronic records. Results Forty patients were enrolled between February 2017 and July 2018. A hydrogel spacer significantly reduced the dose to the rectum. Grade 2 acute GI and GU toxicity occurred in seven (18%) and 17 (44%) patients. The EPIC bowel and urinary summary score declined from the baseline to the first month (P < 0.01, < 0.01), yet it was still significantly lower in the third month (P < 0.01, P = 0.04). For propensity score-matched analyses, no significant differences in acute GI and GU toxicity were observed between the two groups. The EPIC bowel summary score was significantly better in the spacer group at 1 month (82.2 in the spacer group and 68.5 in the control group). Conclusions SBRT with a hydrogel spacer had the dosimetric benefits of reducing the rectal doses. The use of the hydrogel spacer did not reduce physician-assessed acute toxicity, but it improved patient-reported acute bowel toxicity. Trial registration: Trial registration: UMIN-CTR, UMIN000026213. Registered 19 February 2017, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029385.

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109 Intensity-modulated radiotherapy (IMRT) reduces acute toxicity in the treatment of rectal cancer: results of a phase II study

Radiotherapy and Oncology ◽

10.1016/s0167-8140(04)80609-1 ◽

2004 ◽

Vol 72 ◽

pp. S33 ◽

Cited By ~ 1

Keyword(s):

Rectal Cancer ◽

Acute Toxicity ◽

Phase Ii ◽

Phase Ii Study ◽

Intensity Modulated Radiotherapy ◽

Intensity Modulated

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A Phase II Study of Stereotactic Body Radiotherapy with Hydrogel Spacer for Prostate Cancer; Dosimetric Comparison, Acute Toxicity and Quality of Life

International Journal of Radiation Oncology*Biology*Physics ◽

10.1016/j.ijrobp.2019.06.1851 ◽

2019 ◽

Vol 105 (1) ◽

pp. E298-E299

Author(s):

M. Ogita ◽

H. Yamashita ◽

Y. Nozawa ◽

S. Ozaki ◽

S. Sawayanagi ◽

...

Keyword(s):

Quality Of Life ◽

Prostate Cancer ◽

Acute Toxicity ◽

Phase Ii ◽

Stereotactic Body Radiotherapy ◽

Phase Ii Study ◽

Dosimetric Comparison

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Prospective Randomized Phase II Study of Stereotactic Body Radiotherapy (SBRT) vs. Conventional Fractionated Radiotherapy (CFRT) for Chinese Patients with Early-Stage Localized Prostate Cancer

Current Oncology ◽

10.3390/curroncol29010003 ◽

2021 ◽

Vol 29 (1) ◽

pp. 27-37

Author(s):

Darren M. C. Poon ◽

Daisy Lam ◽

Kenneth Wong ◽

Cheuk Man Chu ◽

Michael Cheung ◽

...

Keyword(s):

Prostate Cancer ◽

Phase Ii ◽

Stereotactic Body Radiotherapy ◽

Phase Ii Study ◽

Early Stage ◽

Localized Prostate Cancer ◽

Chinese Patients ◽

Chinese Men ◽

Fractionated Radiotherapy ◽

Patient Reported

Background: Stereotactic body radiotherapy (SBRT) has potential radiobiologic and economic advantages over conventional fractionated radiotherapy (CFRT) in localized prostate cancer (PC). This study aimed to compare the effects of these two distinct fractionations on patient-reported quality of life (PRQOL) and tolerability. Methods: In this prospective phase II study, patients with low- and intermediate-risk localized PC patients were randomly assigned in a 1:1 ratio to the SBRT (36.25 Gy/5 fractions/2 weeks) or CFRT (76 Gy/38 fractions/7.5 weeks) treatment groups. The primary endpoint of variation in PRQOL at 1 year was assessed by changes in the Expanded Prostate Cancer Index Composite (EPIC) questionnaire scores and analysed by z-tests and t-tests. Results: Sixty-four eligible Chinese men were treated (SBRT, n = 31; CFRT, n = 33) with a median follow-up of 2.3 years. At 1 year, 40.0%/46.9% of SBRT/CFRT patients had a >5-point decrease in bowel score (p = 0.08/0.28), respectively, and 53.3%/46.9% had a >2-point decrease in urinary score (p = 0.21/0.07). There were no significant differences in EPIC score changes between the arms at 3, 6, 9 and 12 months, but SBRT was associated with significantly fewer grade ≥ 1 acute and 1-year late gastrointestinal toxicities (acute: 35% vs. 87%, p < 0.0001; 1-year late: 64% vs. 84%, p = 0.03), and grade ≥ 2 acute genitourinary toxicities (3% vs. 24%, p = 0.04) compared with CFRT. Conclusion: SBRT offered similar PRQOL and less toxicity compared with CFRT in Chinese men with localized PC.

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PATRIOT Trial: Randomized phase II study of prostate stereotactic body radiotherapy comparing 11 versus 29 days overall treatment time.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.7_suppl.6 ◽

2015 ◽

Vol 33 (7_suppl) ◽

pp. 6-6 ◽

Cited By ~ 9

Author(s):

Harvey Charles Quon ◽

Aldrich Ong ◽

Patrick Cheung ◽

William Chu ◽

Hans T. Chung ◽

...

Keyword(s):

Prostate Cancer ◽

Phase Ii ◽

Stereotactic Body Radiotherapy ◽

Treatment Time ◽

Phase Ii Study ◽

Overall Treatment Time ◽

Randomized Phase Ii ◽

Grade 3 ◽

The Impact

6 Background: Stereotactic body radiotherapy (SBRT) for the treatment of prostate cancer is rapidly increasing. Reported regimens differ in time, dose, and fractionation. We report the results of a multicentre, Canadian randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL) and toxicity. Methods: Men with cT1-2b, Gleason <=7, and PSA <= 20 ng/mL prostate cancer were randomly assigned to 40 Gy in 5 fractions delivered every other day (11 days) vs. once per week (29 days) using gantry-based SBRT. QOL was assessed using the Expanded Prostate Cancer Index Composite (EPIC) at baseline, weeks 2, 4, 6, 12, months 6 and 12, then annually. Toxicity was graded according to RTOG Criteria. The primary end point was the proportion of patients with a minimum clinically important change (MCIC) in bowel QOL at any time during the acute (<=12 week) period and was analyzed by Fisher’s exact test with a two-sided p < 0.05 considered significant. MCIC was defined as a decrease in EPIC score of >0.5 standard deviation of the baseline value. ClinicalTrials.gov NCT01423474. Results: 152 men from 3 centres were randomized with a median follow-up of 13.1 months. Baseline characteristics were similar in both arms except for the International Prostate Symptom Score with medians of 4 vs. 7 in the 11 and 29 day groups, respectively (p=0.02). There were significant differences between the 11 and 29 day groups in the proportion of patients with acute MCIC in bowel (90.0% vs. 69.6%, p<0.01) and urinary (95.7% vs. 74.6%, p<0.01) scores, respectively. No differences were found in acute sexual (p=0.38) or hormonal (p=0.48) QOL. Worst acute grade 1, 2, 3 toxicities were 64, 18, 0% vs. 41, 11, 0% (p<0.01) for GI and 38, 32, 1% vs. 30, 34, 3% (p=0.69) for GU in the 11 and 29 day groups, respectively. There were no late grade 3+ GI toxicities. Late grade 3 GU toxicity occurred in 1 vs. 0 patients in the 11 and 29 day arms (p=0.32). Conclusions: Prostate SBRT delivered over 29 days was associated with superior bowel and urinary QOL compared to 11 days in the first 3 months of treatment. There were few severe (grade 3+) toxicities in either group. Follow-up is continuing to compare long-term outcomes. Clinical trial information: NCT01423474.

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Phase II Study of Stereotactic Body Radiotherapy with Hydrogel Spacer for Prostate Cancer: Acute Toxicity and Propensity Score-matched Comparison

10.21203/rs.3.rs-467632/v1 ◽

2021 ◽

Author(s):

Mami Ogita ◽

Hideomi Yamashita ◽

Yuki Nozawa ◽

Sho Ozaki ◽

Subaru Sawayanagi ◽

...

Keyword(s):

Prostate Cancer ◽

Propensity Score ◽

Acute Toxicity ◽

Phase Ii ◽

Stereotactic Body Radiotherapy ◽

Phase Ii Study ◽

Summary Score ◽

Trial Registration ◽

Gu Toxicity ◽

Patient Reported

Abstract BackgroundThe efficacy of a hydrogel spacer in stereotactic body radiotherapy (SBRT) has not been clarified. We evaluated the safety and efficacy of SBRT in combination with a hydrogel spacer for prostate cancer. MethodsThis is a prospective single-center, single-arm phase II study. Prostate cancer patients without lymph node or distant metastasis were eligible. All patients received a hydrogel spacer insertion, followed by SBRT of 36.25 Gy in 5 fractions with volumetric modulated arc therapy. The primary endpoint was physician-assessed acute gastrointestinal (GI) toxicity within 3 months. The secondary endpoints were physician-assessed acute genitourinary (GU) toxicity, patient-reported outcomes evaluated by the EPIC and FACT-P questionnaires, and dosimetric comparison. We used propensity score-matched analyses to compare patients with the hydrogel spacer with those without the spacer. The historical data of the control without a hydrogel spacer was obtained from our hospital’s electronic records. ResultsForty patients were enrolled between February 2017 and July 2018. A hydrogel spacer significantly reduced the dose to the rectum. Grade 2 acute GI and GU toxicity occurred in seven (18%) and 17 (44%) patients. The EPIC bowel and urinary summary score declined from the baseline to the first month (P < 0.01, < 0.01), yet it was still significantly lower in the third month (P < 0.01, P = 0.04). For propensity score-matched analyses, no significant differences in acute GI and GU toxicity were observed between the two groups. The EPIC bowel summary score was significantly better in the spacer group at 1 month (82.2 in the spacer group and 68.5 in the control group). ConclusionsSBRT with a hydrogel spacer had the dosimetric benefits of reducing the rectal doses. The use of the hydrogel spacer did not reduce physician-assessed acute toxicity, but it improved patient-reported acute bowel toxicity.Trial registrationTrial registration: UMIN-CTR, UMIN000026213. Registered 19 February 2017, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029385

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