NCT06665932Recruiting
Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins
Source: ClinicalTrials.gov · Last updated 12 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 29 Oct 2024
- Start date
- 1 Nov 2024
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- University Hospital Ostrava
- Diseases
- Prostate cancer
- NCT number
- NCT06665932
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Nov 2024 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous treatment with radiotherapy to the pelvic area
Other
- 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)
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.