Ignite Creation Date:
2024-07-17 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461793
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-11
Brief Title:
Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy and Hormone Therapy With SpaceOAR TM for Patients With High - Risk Localized Prostate Cancer DESAR-H
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy and Hormone Therapy With SpaceOAR TM for Patients With High - Risk Localized Prostate Cancer DESAR-H
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DESAR-H
Brief Summary:
Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients who underwent low-fractionation curative radiation therapy and hormone therapy
Detailed Description:
In prostate cancer radiation therapy for curative purposes can be used regardless of the stage if there is no distant metastasis and radiation therapy and hormone therapy may be combined in patients with moderate or high risk factors for recurrence Randomized prospective studies to investigate the therapeutic effect of increasing dose escalation to 70 Gy or more showed significant reductions 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 αβ ratio is 15 which is smaller than surrounding normal tissues such as the bladder 40 and the rectum 39 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 119 and 117 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 EQD1 Gyαβ15
Low-fraction radiation therapy 70 Gy 28 sessions 800 Gy
Conventional fractionation radiation therapy 74 Gy 37 times 74 Gy
CHHIP trial 60 Gy 20 times 7714 Gy
study design dose64 Gy 20 times 8594 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 performs biodegradable material injection before radical radiotherapy in combination with hormone therapy in high - risk prostate cancer patients The investigator plans to conduct a phase II clinical study to evaluate the safety of high - risk prostate cancer patients who has received subdivision radical radiation therapy with hormone therapy
Table 1 Biological Equivalent Dose by Radiation Therapy Policy 2-Gy fraction comparison
Protocol EQD1 Gyαβ15
Low-fraction radiation therapy 70 Gy 28 sessions 800 Gy
Conventional fractionation radiation therapy 74 Gy 37 times 74 Gy
CHHIP trial 60 Gy 20 times 7714 Gy
study design dose64 Gy 20 times 8594 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 performs biodegradable material injection before radical radiotherapy in combination with hormone therapy in high - risk prostate cancer patients The investigator plans to conduct a phase II clinical study to evaluate the safety of high - risk prostate cancer patients who has received subdivision radical radiation therapy with hormone therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None