RecruitingNot ApplicableNCT06665932

Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins


Sponsor

University Hospital Ostrava

Enrollment

100 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria9

  • 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 Criteria6

  • 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

Interventions

PROCEDUREStereotactic 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

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NCT06665932


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