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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
histologically verified, localized prostate cancer without regional lymphadenopathy or distant metastases
low or intermediate risk - favorable risk
low risk: no staging required
intermediate risk- favorable risk: CT abdomen and pelvis
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Stereotactic radiotherapy
Procedure/SurgeryStereotactic 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.
Treatment groups
Trial outcomes
Primary outcomes
Acute toxicity incidence
Incidence of acute urological toxicity grade 2 and more according to the Common Terminology Criteria for Adverse Events (CTCAE) 4.03 scale
Acute toxicity of the lower gastrointestinal tract (GIT)
Incidence of acute toxicity of the lower GIT grade 2 and more according to the Common Terminology Criteria for Adverse Events (CTCAE) 4.03 scale
Secondary outcomes
5-year cumulative toxicity
5-year cumulative toxicity (urological and lower GIT) according to the CTCAE 4.03 scale
Quality of Life according to the EPIC-26 scale
Quality of Life will be assessed using the Expanded Prostate Cancer Index Composite (EPIC-26) scale
Quality of life (EQ-5D)
Quality of Life will be assessed using the EQ-5D tool
Sponsors and contacts
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