Safety of increased radiation doses with hormone therapy for high-risk prostate cancer
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)
This study is testing if giving higher doses of radiation along with hormone therapy can help men with high-risk prostate cancer without causing too many side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 20 Years and up |
| Sex | Male |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06461793 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety of dose escalation in hypofractionated radiation therapy combined with hormone therapy for patients with high-risk localized prostate cancer. It aims to determine whether increasing the radiation dose to 70 Gy or more can reduce the risk of biochemical failure while minimizing side effects to surrounding normal tissues. The study utilizes advanced techniques such as intensity-modulated radiation therapy (IMRT) and image-guided radiation therapy (IGRT) to enhance treatment efficacy. Participants will receive a biodegradable material injection to facilitate the treatment process.
Who should consider this trial
Good fit: Ideal candidates include adults over 20 with histologically confirmed high-risk prostate adenocarcinoma who are undergoing hormone therapy.
Not a fit: Patients with a history of pelvic surgery, previous radiation therapy, or those with metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and reduce recurrence rates in patients with high-risk prostate cancer.
How similar studies have performed: Previous studies have shown promising results with similar dose escalation approaches in prostate cancer treatment, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Won Park, M.D., Ph.D.
- Email: wonro.park@samsung.com
- Phone: +82-2-3410-2616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.