Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins
Recruiting · NCT06665932 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital Ostrava
View the official record on ClinicalTrials.gov →Interventions studied
Stereotactic radiotherapy
What this trial is about
The study aims to reduce the PTV (Planning Target Volume) safety margins to 1-2 mm in stereotactic prostate radiotherapy for low- and medium-risk prostate cancers while maintaining a dose of 36.25 Gy in 5 fractions per day. By reducing the hems, the investigators expect a reduction of acute and late toxicity on the organs at risk, dominantly the urethra, bladder, penile bulb, and rectum, and an improvement in the quality of life.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- University Hospital Ostrava - Ostrava, Moravian-Silesian Region, Czechia