Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 20 and up Men only

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.

More High-risk Prostate Cancer trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages20 Years and up
SexMen only
Enrollment33 (estimated)
SponsorSamsung Medical Center
Academic / other
Drugs / interventionsradiation
Locations1 site (Seoul)
StatusRecruiting
StartedSeptember 12, 2023
Main results expectedDecember 31, 2033
Study endsDecember 31, 2033
Registry record updatedJune 21, 2024
Trial IDNCT06461793 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.