Clinical trial NCT06461793: 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)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: High Risk Prostate Carcinoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 33
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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 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.

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

Primary outcomes:
measure: NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) V 5.0 Frequency of rectal bleeding of grade 1 or higher within 3 years
timeFrame: 3 years after radiation therapy of each participant
Secondary outcomes:
measure: Radiation therapy-related side effects other than rectal bleeding
timeFrame: up to 2 years afte radiation therapy on each participant
measure: Side effects related to biodegradable material injection
timeFrame: each participant finished with radiation therapy and see after 3-6 months for acute adverse events, 1-5 years for chronic adverse events
measure: biochemical recurrence-free survival
timeFrame: 5 years after radiation therapy of each participant
measure: progression-free survival
timeFrame: up to 5 years after radiation therapy of each participant
measure: overall survival
timeFrame: up to 5 years after radiation therapy of each participant
measure: quality of life on high-risk prostate cancer patients by using EPIC questionnaire
timeFrame: up to 5 years after radiation therapy of each participant
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: