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Research Article
Mami Ogita
The University of Tokyo Hospital: Tokyo Daigaku Igakubu Fuzoku Byoin
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1539-4298
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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
Keywords
Prostate Cancer, Radiation Therapy, Stereotactic Body Radiotherapy, Toxicity, Hydrogel, Patient-reported Outcomes
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CURRENT STATUS: Under Review
Version 1
Posted 29 Apr, 2021
No community comments so far
Editorial decision: Major revision
On 16 May, 2021
Review #1 received
Received 28 Apr, 2021
Review #2 received
Received 28 Apr, 2021
Reviewer #2 agreed
On 26 Apr, 2021
Reviewer #1 agreed
On 26 Apr, 2021
Reviewers invited
Invitations sent on 26 Apr, 2021
Reviews received
Received 26 Apr, 2021
First submitted
On 26 Apr, 2021
Editor assigned
On 25 Apr, 2021
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On 25 Apr, 2021
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On 25 Apr, 2021
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
This preprint is under consideration at Radiation Oncology. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research Article
Mami Ogita
The University of Tokyo Hospital: Tokyo Daigaku Igakubu Fuzoku Byoin
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1539-4298
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 29 Apr, 2021
No community comments so far
Editorial decision: Major revision
On 16 May, 2021
Review #1 received
Received 28 Apr, 2021
Review #2 received
Received 28 Apr, 2021
Reviewer #2 agreed
On 26 Apr, 2021
Reviewer #1 agreed
On 26 Apr, 2021
Reviewers invited
Invitations sent on 26 Apr, 2021
Reviews received
Received 26 Apr, 2021
First submitted
On 26 Apr, 2021
Editor assigned
On 25 Apr, 2021
Submission checks complete
On 25 Apr, 2021
Editor invited
On 25 Apr, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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
Figure 1
Figure 2
Figure 3
Figure 4
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