NCT06461819RecruitingPhase 2
Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy With SPACEOAR TM for Patients With Low-to-intermediate Risk Localized Prostate Cancer (DESAR-L)
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)
A single institution with a single group, a phase II study, low- and medium-risk studies performed after biodegradable substance injection prostate cancer dosage increase. The investigator plans to evaluate grade 1 or higher rectal bleeding occurring within 3 years in patients who have received low -fractionation curative radiotherapy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 11 Jun 2024
- Start date
- 11 Aug 2023
- Primary completion date
- 31 Dec 2033
- Lead sponsor
- Samsung Medical Center
- Diseases
- Prostate cancer
- NCT number
- NCT06461819
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 33
- From 11 Aug 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
- Patients who have undergone or are scheduled to undergo hormone therapy
Other illness
- Prostatectomy, 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
- Biodegradable material Patients who failed infusion
- Patients with distant metastasis and intrapelvic lymph node metastasis
Who the study is looking for
- Prostate cancer patients confirmed histopathologically within 6 months prior to study enrollment
- Low-risk and medium- risk groups in terms of risk Prostate cancer patients (primary stage T2c or less, Grade group 3 or less, If PSA is less than 20ng/ml)
- Adults over 20 years of age
- Whole body performance ECOG 0-1
- SpaceOAR Patients who consented to the procedure and the clinical study
Age in the registry: 20 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile 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.