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Recruiting

NCT Number: NCT06665932

Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

Location status: Recruiting

Location contact

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Lukáš Knybel, Ing., Ph.D.

SUB_INVESTIGATOR

Pavla Benýšková, Mgr., Ph.D.

SUB_INVESTIGATOR

Pavla Hanzlíková, MD, Ph.D., MBA

SUB_INVESTIGATOR

Tomáš Blažek, MD, Ph.D.

SUB_INVESTIGATOR

Zuzana Růžičková, MD

SUB_INVESTIGATOR

Zuzana Zděblová-Čermáková, MD, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

In this prospective study, a total of 100 patients will be treated over 2 years. Patients will be implanted with 4 contrast markers (fiducials) in the prostate - in the base, apex, and right and left lobes of the prostate. Subsequently, 3 planning examinations will be performed: 1. CT with a urinary catheter immediately after the implantation of fiducials (gold contrast markers), with a distance from implantation 2. planning CT and MR without a urinary catheter. The CTV (Clinical Target Volume) will be defined by the prostate, and the border on the PTV will be reduced from 3-5 mm to 1-2 mm isometrically to maximize the reduction of doses to the organs at risk (rectum, bladder, and urethra, penile bulb, testes), the organs at risk (OAR) will be marked in the radiation plan as OAR. Subsequently, the patients will be irradiated with a dose of 36.25 Gy in 5 fractions per day. Acute toxicity will be evaluated in the 1st and 3rd month after radiotherapy, and late toxicity after 4-6 months according to CTCAE criteria (Common Terminology Criteria for Adverse Events).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic radiotherapy

Procedure

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.

Primary outcomes

  1. Acute toxicity incidence

    Time frame: 3 months from treatment

    Incidence of acute urological toxicity grade 2 and more according to the Common Terminology Criteria for Adverse Events (CTCAE) 4.03 scale

  2. Acute toxicity of the lower gastrointestinal tract (GIT)

    Time frame: 3 months from treatment

    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

  1. 5-year cumulative toxicity

    Time frame: 5 years

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

  2. Quality of Life according to the EPIC-26 scale

    Time frame: 5 years from treatment

    Quality of Life will be assessed using the Expanded Prostate Cancer Index Composite (EPIC-26) scale

  3. Quality of life (EQ-5D)

    Time frame: 5 years from treatment

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 30, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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