Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Hospital Ostrava

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Stereotactic radiotherapy

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Men with prostate cancerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3 months from treatment
2

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

Time frame
3 months from treatment

Secondary outcomes

1

5-year cumulative toxicity

5-year cumulative toxicity (urological and lower GIT) according to the CTCAE 4.03 scale

Time frame
5 years
2

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

Time frame
5 years from treatment
3

Quality of life (EQ-5D)

Quality of Life will be assessed using the EQ-5D tool

Time frame
5 years from treatment

Other outcomes

Sponsors and contacts

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