RECRUITINGINTERVENTIONAL
Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form form
- suitable position of fiducials (to be determined by the physicist)
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
PROCEDURE
Stereotactic radiotherapy
Stereotactic surgery is a minimally invasive form of surgical intervention that makes use of a three-dimensional coordinate system to locate small targets inside the body and to perform on them some action such as ablation, biopsy, lesion, injection, stimulation, implantation, radiosurgery, etc.
Locations (1)
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia