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Recruiting NCT06665932

Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins

No phase Interventional Prostate Cancer (Adenocarcinoma)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stereotactic radiotherapy.
Who it may be relevant to
Registry conditions: Prostate Cancer (Adenocarcinoma). Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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).

Interventions

  • 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.

Primary outcome measures

  • Acute toxicity incidence [Time frame: 3 months from treatment]
  • Acute toxicity of the lower gastrointestinal tract (GIT) [Time frame: 3 months from treatment]
Secondary outcome measures (3)
  • 5-year cumulative toxicity [Time frame: 5 years]
  • Quality of Life according to the EPIC-26 scale [Time frame: 5 years from treatment]
  • Quality of life (EQ-5D) [Time frame: 5 years from treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • University Hospital Ostrava — Ostrava

Publications

  • Kishan AU, Ma TM, Lamb JM, Casado M, Wilhalme H, Low DA, Sheng K, Sharma S, Nickols NG, Pham J, Yang Y, Gao Y, Neylon J, Basehart V, Cao M, Steinberg ML. Magnetic Resonance Imaging-Guided vs Computed Tomography-Guided Stereotactic Body Radiotherapy for Prostate Cancer: The MIRAGE Randomized Clinical Trial. JAMA Oncol. 2023 Mar 1;9(3):365-373. doi: 10.1001/jamaoncol.2022.6558. PMID 36633877
  • Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87. doi: 10.1016/ PMID 17482880

Identifiers

NCT: NCT06665932 · ONK-11-SBRT · 16/RVO-FNOs/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗