NCT06461793RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 21 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 11 Jun 2024
- Start date
- 12 Sept 2023
- Primary completion date
- 31 Dec 2033
- Lead sponsor
- Samsung Medical Center
- Diseases
- Prostate cancer
- NCT number
- NCT06461793
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 33
- From 12 Sept 2023 to the primary completion date, 31 Dec 2033
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a history of previous pelvic radiation therapy
Other illness
- 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
Other
- Patients with lymph node metastasis or distant metastasis
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.