Safety of increased radiation doses with hormone therapy for high-risk prostate cancer
Official title: 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)
Run by Samsung Medical Center · NCT06461793 · Data updated 2026-11-12
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 |
| Ages | 20 Years and up |
| Sex | Men only |
| Enrollment | 33 (estimated) |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | September 12, 2023 |
| Main results expected | December 31, 2033 |
| Study ends | December 31, 2033 |
| Registry record updated | June 21, 2024 |
| Trial ID | NCT06461793 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 20 with histologically confirmed high-risk prostate adenocarcinoma who are undergoing hormone therapy.
✕Probably not a fit
Patients with a history of pelvic surgery, previous radiation therapy, or those with metastasis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results with similar dose escalation approaches in prostate cancer treatment, indicating potential for success.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Darolutamide with standard or higher-dose targeted prostate radiotherapy plus hormone therapy for men with high-risk localized prostate cancer
This trial tests whether adding darolutamide and/or using higher-dose targeted prostate radiotherapy together with hormone therapy and pelvic nodal radiotherapy helps men with localized high‑risk prostate cancer stay free of metastatic disease longer.
-
Combining advanced treatments for high risk prostate cancer
This study is testing a new treatment approach for men with high risk prostate cancer to see if combining different therapies can improve their outcomes while causing fewer side effects.
-
Comparing Lutetium-177 and Actinium-225 PSMA-targeted radiation before prostatectomy
This will test whether giving one of two PSMA-targeted radiation drugs (Lutetium-177 or Actinium-225) before prostate removal works differently in men with high or very high-risk localized prostate cancer.
-
Targeted tumor boost and shortened radiation schedules for prostate cancer
This trial tests whether giving a higher radiation dose to the tumor inside the prostate (a focal boost) and delivering treatment in 12 instead of 20 sessions helps men with intermediate- or high-risk prostate cancer have fewer relapses and need less hormonal therapy.
-
Radiation therapy options for high-risk prostate cancer
This trial tests different ways of giving radiation therapy to see which balance best controls the cancer with the fewest side effects in men with high-risk, non-metastatic prostate cancer.
-
Repeated PSMA PET scans to monitor treatment response in clinically significant prostate cancer.
This project will test whether doing a PSMA PET/CT before treatment and again after treatment (or at early PSA rise) helps track response in people with newly diagnosed clinically significant (Gleason ≥7) prostate cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.