NCT06461819 Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy With SPACEOAR TM for Patients With Low-to-intermediate Risk Localized Prostate Cancer (DESAR-L)
| NCT ID | NCT06461819 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Samsung Medical Center |
| Condition | Low-to-intermediate-risk Prostate Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2023-08-11 |
| Primary Completion | 2033-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 33 participants in total. It began in 2023-08-11 with a primary completion date of 2033-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Prostate cancer patients confirmed histopathologically within 6 months prior to study enrollment 2. 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) 3. Adults over 20 years of age 4. Whole body performance ECOG 0-1 5. SpaceOAR Patients who consented to the procedure and the clinical study Exclusion Criteria: 1. Prostatectomy, 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. Biodegradable material Patients who failed infusion 5. Patients with a history of previous pelvic radiation therapy 6. Patients with distant metastasis and intrapelvic lymph node metastasis 7. Patients who have undergone or are scheduled to undergo hormone therapy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06461819 clinical trial?
This trial is open to male participants only, aged 20 Years or older, studying Low-to-intermediate-risk Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06461819 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06461819 currently recruiting?
Yes, NCT06461819 is actively recruiting participants. Contact the research team at wonro.park@samsung.com for enrollment information.
Where is the NCT06461819 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06461819 clinical trial?
NCT06461819 is sponsored by Samsung Medical Center. The trial plans to enroll 33 participants.