Reducing safety margins in stereotactic radiotherapy for prostate cancer
Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins
This study is testing if reducing safety margins in radiation therapy for low- and medium-risk prostate cancer can make treatment safer and more effective for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Hospital Ostrava Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Ostrava, Moravian-Silesian Region) |
| Trial ID | NCT06665932 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include men over 18 with localized acinar adenocarcinoma of the prostate, classified as low or intermediate risk, and without prior pelvic radiotherapy.
Not a fit: Patients with advanced prostate cancer, distant metastases, or unsuitable fiducial marker placement will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce treatment-related side effects for patients with prostate cancer.
How similar studies have performed: While similar approaches have been explored, this specific method of reducing safety margins in stereotactic radiotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ostrava, Moravian-Silesian Region
- University Hospital Ostrava — Ostrava, Moravian-Silesian Region, Czechia (Recruiting)
Study contacts
- Study coordinator: Jiří Hynčica
- Email: jiri.hyncica@fno.cz
- Phone: 0042059737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.