Evaluating safety of increased radiation doses for prostate cancer treatment

Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy With SPACEOAR TM for Patients With Low-to-intermediate Risk Localized Prostate Cancer (DESAR-L)

This study is testing whether giving higher doses of radiation safely helps men with low-to-intermediate risk prostate cancer while keeping side effects, like rectal bleeding, to a minimum.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 20 Years and up
• Sex: Male
• Sponsor: Samsung Medical Center (other)
• Drugs / interventions: radiation
• Locations: 1 site (Seoul)
• Trial ID: NCT06461819 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial investigates the safety of dose escalation in hypofractionated radiation therapy for patients with low-to-intermediate risk localized prostate cancer. The study involves administering a biodegradable substance prior to increasing the radiation dose, with a focus on monitoring rectal bleeding and other side effects over a three-year period. The trial aims to determine if higher doses can reduce the risk of cancer recurrence while minimizing adverse effects on surrounding tissues. Participants will be closely monitored to assess the balance between treatment efficacy and safety.

Who should consider this trial

Good fit: Ideal candidates include adults over 20 years old with histologically confirmed low-to-intermediate risk localized prostate cancer.

Not a fit: Patients with a history of pelvic surgery, distant metastasis, or those undergoing hormone therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for prostate cancer patients by allowing for higher radiation doses with fewer side effects.

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

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

Where this trial is running

Seoul

• Samsung Medical Center — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Won Park, M.D., Ph.D.

Conditions: Low-to-intermediate-risk Prostate Carcinoma