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)

Trial 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)

NCT ID: NCT06461793

Condition: High Risk Prostate Carcinoma

Conditions: Official terms:
Prostatic Neoplasms

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: - A single institution with a single group, a phase II study, we plan to evaluate grade 1 or higher rectal bleeding within 3 years in high-risk prostate cancer patients who received biodegradable substance injection followed by curative radiotherapy in combination with hormone therapy.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients
Description: this researcher performed biodegradable material injection during radical radiotherapy in combination with hormone therapy in high - risk prostate cancer patients. after subdivision radical received radiation therapy We plan to conduct a phase II clinical study to evaluate the safety of prostate cancer patients.
Arm group label: Prostate cancer patient, candidate of definitive radiation treatment

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 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: EQD1 (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 Gy, 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 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Histopathologically confirmed prostate adenocarcinoma within 6 months of study enrollment 2. Patients with prostate cancer at high risk or above (c T3a-T4 or grade group 4-5 or PSA > 20 n g/mL) ) 3. Patients who have undergone or are scheduled to undergo hormone therapy for high-risk prostate cancer 4. Adults over 20 years of age 5. Whole body performance ECOG 0-1 6. SpaceOAR Patients who consented to the procedure and study Exclusion Criteria: 1. prostate removal surgery, Patients with a history of lower pelvic surgery including rectal cancer surgery 2. primary cancer Patients with posterior extracapsular extension 3. Medically biodegradable substances such as bleeding predisposition Patients for whom infusion is not appropriate 4. Patients with a history of previous pelvic radiation therapy 5. Patients with lymph node metastasis or distant metastasis

Gender: Male

Gender based: Yes

Gender description: Histopathologically confirmed prostate adenocarcinoma within 6 months of study enrollment

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Won Park, M.D., Ph.D.

Phone: +82-2-3410-2616
Email: wonro.park@samsung.com

Start date: September 12, 2023

Completion date: December 31, 2033

Lead sponsor:
Agency: Samsung Medical Center
Agency class: Other

Source: Samsung Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06461793
https://www.bostonscientific.com/content/dam/bostonscientific/spaceoar/vue/infographic-spaceoar-hydrogel-meta-analysis.pdf