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)

NCT06461793 | Recruiting Phase 2

• 1 other identifier: SMC 2023-06-140
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

High Risk Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) V 5.0 Frequency of rectal bleeding of grade 1 or higher within 3 years

  Adverse Event within three years after the radiation therapy

  3 years after radiation therapy of each participant

Secondary Outcomes (6)

• Radiation therapy-related side effects other than rectal bleeding

  up to 2 years afte radiation therapy on each participant

• Side effects related to biodegradable material injection

  each participant finished with radiation therapy and see after 3-6 months for acute adverse events, 1-5 years for chronic adverse events

• biochemical recurrence-free survival

  5 years after radiation therapy of each participant

• progression-free survival

  up to 5 years after radiation therapy of each participant

• overall survival

  up to 5 years after radiation therapy of each participant

Study Arms (1)

Prostate cancer patient, candidate of definitive radiation treatment

EXPERIMENTAL

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.

Radiation: Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients

Interventions

Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients RADIATION

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.

Prostate cancer patient, candidate of definitive radiation treatment

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Histopathologically confirmed prostate adenocarcinoma within 6 months of study enrollment
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically confirmed prostate adenocarcinoma within 6 months of study enrollment
• Patients with prostate cancer at high risk or above (c T3a-T4 or grade group 4-5 or PSA \> 20 n g/mL) )
• Patients who have undergone or are scheduled to undergo hormone therapy for high-risk prostate cancer
• Adults over 20 years of age
• Whole body performance ECOG 0-1
• SpaceOAR Patients who consented to the procedure and study

You may not qualify if:

• prostate removal surgery, Patients with a history of lower pelvic surgery including rectal cancer surgery
• primary cancer Patients with posterior extracapsular extension
• Medically biodegradable substances such as bleeding predisposition Patients for whom infusion is not appropriate
• Patients with a history of previous pelvic radiation therapy
• Patients with lymph node metastasis or distant metastasis

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Related Links

• SpaceOAR™ Hydrogel is Associated with Lower Rectal Toxicity and Higher Bowel Quality of Life in Late Follow-up: Systematic Review \& Meta-Analysis

Central Study Contacts

Won Park, M.D., Ph.D.

CONTACT

+82-2-3410-2616; wonro.park@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Won Park, M.D., Ph.D.

Model Details: \- 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.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: September 12, 2023
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2033
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

KR (1)