Reducing safety margins in stereotactic radiotherapy for prostate cancer

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 study aims to improve the safety and effectiveness of stereotactic radiotherapy for low- and medium-risk prostate cancer by reducing the Planning Target Volume (PTV) safety margins to 1-2 mm while delivering a dose of 36.25 Gy in 5 fractions. A total of 100 patients will be treated over two years, with fiducial markers implanted in the prostate to enhance precision during radiation delivery. The study will evaluate acute toxicity at 1 and 3 months post-treatment and late toxicity at 4-6 months, using established criteria to assess the impact on surrounding organs. The goal is to minimize toxicity and improve patients' quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* histologically verified, localized prostate cancer without regional lymphadenopathy or distant metastases
* low or intermediate risk - favorable risk
* staging according to NCCN recommendations:
* low risk: no staging required
* intermediate risk- favorable risk: CT abdomen and pelvis
* PSA up to 15
* age over 18 years
* signed informed consent form
* suitable position of fiducials (to be determined by the physicist)

Exclusion Criteria:

* a histological type other than acinar adenocarcinoma
* the presence of local lymphadenopathy or distant metastases
* a dominant lesion in the periphery that is in contact with the capsule or grows through it
* PSA over 15
* unsatisfactory position of fiducials (to be determined by the physicist)
* previous treatment with radiotherapy to the pelvic area

Where it's running

• University Hospital Ostrava
  Ostrava, Moravian-Silesian Region, Czechia Recruiting

Study contacts

• Study coordinator: Jiří Hynčica
• Email: jiri.hyncica@fno.cz
• Phone: 0042059737

Similar studies

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

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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.