Evaluating safety of increased radiation doses for prostate cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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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• Targeted tumor boost and shortened radiation schedules for prostate cancer

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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.