1. In Curative Stereotactic Body Radiation Therapy for Prostate Cancer, There Is a High Possibility That 45 Gy in Five Fractions Will Not Be Tolerated without a Hydrogel Spacer.
- Author
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Sawayanagi, Subaru, Yamashita, Hideomi, Ogita, Mami, Kawai, Taketo, Sato, Yusuke, and Kume, Haruki
- Subjects
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PHARMACEUTICAL arithmetic , *DRUG toxicity , *DOSE-response relationship (Radiation) , *RADIOTHERAPY , *DEATH , *PATIENT safety , *PROSTATE tumors , *RADIOSURGERY , *DESCRIPTIVE statistics , *RADIATION doses , *DRUGS , *DISEASE relapse , *RECTUM , *HEMORRHAGE , *BIOMARKERS - Abstract
Simple Summary: While stereotactic body radiation therapy (SBRT) has become increasingly used for the treatment of non-metastatic prostate cancer since its insurance coverage in Japan in 2016, optimal dose fractionation remains undetermined. This study was a phase 1 dose escalation trial of SBRT, aiming to assess the maximum tolerated dose (MTD) of SBRT using five fractions. Patients were planned to receive SBRT at doses of 42.5, 45, or 47.5 Gy, with toxicity as the primary endpoint. No dose-limiting toxicities were observed at 42.5 Gy, and one patient experienced a grade 4 rectal perforation at 45 Gy, leading to the determination of 42.5 Gy as the MTD. There were no deaths or biochemical recurrences during the follow-up period. This study underscores the need for further trials to ascertain the optimal SBRT dose fractionation, balancing efficacy and safety for non-metastatic prostate cancer treatment. The purpose of this study was to determine the maximum tolerated dose (MTD) for stereotactic body radiation therapy (SBRT) in the treatment of non-metastatic prostate cancer. This study was a phase 1 dose escalation trial conducted in Japan. Patients with histologically proven prostate cancer without lymph nodes or distant metastases were enrolled. The prescribed doses were 42.5, 45, or 47.5 Gy in five fractions. Dose-limiting toxicity (DLT) was defined as grade (G) 3+ gastrointestinal or genitourinary toxicity within 180 days after SBRT completion, and a 6 plus 6 design was used as the method of dose escalation. A total of 16 patients were enrolled, with 6 in the 42.5 Gy group and 10 in the 45 Gy group. No DLT was observed in the 42.5 Gy group. In the 45 Gy group, one patient experienced G3 rectal hemorrhage, and another had G4 rectal perforation, leading to the determination of 42.5 Gy as the MTD. None of the patients experienced biochemical recurrence or death during the follow-up period. We concluded that SBRT for non-metastatic prostate cancer at 42.5 Gy in five fractions could be safely performed, but a total dose of 45 Gy increased severe toxicity. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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