Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy With SPACEOAR TM for Patients With Low-to-intermediate Risk Localized Prostate Cancer (DESAR-L)

In prostate cancer, radiation therapy for curative purposes can be used regardless of stage if there is no distant metastasis. For prostate cancer patients with low-and medium risk, radiotherapy is recommended as standard treatment along with surgery. In randomized prospective studies to investigate the therapeutic effect of dose escalation over 70 Gy during radiation therapy, increasing dose showed a significant reduction in biochemical failure. When the dose is increased, the risk of side effects (digestive system, urinary system) in surrounding normal tissues increases, and intensity modulated radiation therapy (IMRT) or image-guided radiation therapy (IGRT) Application could reduce the probability of side effects. Prostate cancer is a carcinoma characterized by slow growth, and the estimated α/β ratio is 1.5, which is smaller than surrounding normal tissues such as the bladder (4.0) and the rectum (3.9). Therefore, efforts to obtain therapeutic gain through hypofractionated radiation therapy have been attempted using three-dimensional conformal radiotherapy (3D-CRT) and IMRT. In particular, in the CHHIP trial11 announced in 2016, normal division Radiation therapy (74 Gy, 37 splits ) and As a result of comparing low-fractionation radiation therapy (60 Gy, 20 fractions ), there was no significant difference in the 5-year biochemical or clinical recurrence -free survival rate of low-fractionation radiation therapy, it was also reported that there was no difference in rectal and bladder side effects. However, rectal and bladder side effects of grade 2 or higher were 11.9% and 11.7 % during one-time 3 Gy low-fractionated radiotherapy, respectively. The low-fractionated radiotherapy dose is 81 Gy, which is the recommended normal fractionated radiotherapy dose when using IMRT. It can be said that there is a high possibility of showing inferior treatment results in long-term follow-up results because the biological effective dose is lower than that of 'ideal'. (Table 1)

* Table 1 . Biological Equivalent Dose by Radiation Therapy Policy(2-Gy fraction) comparison * Protocol: EQD2 (Gy) (α/β=1.5) * Low-fraction radiation therapy(70 Gy, 28 sessions): 80.0 Gy * Conventional fractionation radiation therapy(74 Gy, 37 times): 74 Gy * CHHIP trial(60 G y, 20 times): 77. 14 Gy * study design dose(64 Gy, 20 times): 85.94 Gy \*EQD2, equivalent dose in 2-Gy fractions

Recently, a method was devised to increase the distance between prostate and rectum by injecting hydrogel between prostate and rectum to minimize rectal dose even when performing high-dose radiotherapy to prostate. In particular, a biodegradable material ( SpaceOAR (hydrogel)) that is absorbed into the body after a certain period of time has been developed, and radical radiation therapy is performed. It is currently being used in prostate cancer patients. It is judged possible to try to increase the radiation dose because the side effects can be reduced by reducing the rectal dose during radical radiation treatment through biodegradable material injection. So far, studies evaluating the side effects of treatment according to increased radiation dose after injection of biodegradable materials are very limited.

Therefore, the investigator uses a biodegradable material injection technique follows by subdivision radical received radiation therapy. The investigator plans to conduct a phase II clinical study to evaluate the safety of prostate cancer patients.

• Radiation therapy-related side effects other than rectal bleeding [Срок оценки: 5 years after each participant's end of radiation therapy after SpaceOAR hydrogel injection]
• Side effects related to biodegradable material injection [Срок оценки: 5 years after radiation therapy of each participant]
• 5-year biochemical recurrence-free survival [Срок оценки: 5 years after radiation therapy of each participant]
• 5-year progression-free survival [Срок оценки: 5 years after radiation therapy of each participant]
• 5-year overall survival [Срок оценки: 5 years after radiation therapy of each participant]
• quality of life in every aspect of life [Срок оценки: 5 years after radiation therapy of each participant]