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Trial Title:
Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins
NCT ID:
NCT06665932
Condition:
Prostate Cancer (Adenocarcinoma)
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
prostate cancer
Stereotactic Body Radiotherapy
acute toxicity
late toxicity
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Stereotactic radiotherapy
Description:
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.
Arm group label:
Men with prostate cancer
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.
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).
Criteria for 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
Gender:
Male
Gender based:
Yes
Gender description:
Only male patients with prostate cancer will be enrolled in the study.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Ostrava
Address:
City:
Ostrava
Zip:
708 52
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Jiří Hynčica
Phone:
0042059737
Phone ext:
2587
Email:
jiri.hyncica@fno.cz
Investigator:
Last name:
Zuzana Zděblová-Čermáková, MD, Ph.D.
Email:
Principal Investigator
Investigator:
Last name:
Tomáš Blažek, MD, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Lukáš Knybel, Ing., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Pavla Benýšková, Mgr., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Zuzana Růžičková, MD
Email:
Sub-Investigator
Investigator:
Last name:
Pavla Hanzlíková, MD, Ph.D., MBA
Email:
Sub-Investigator
Start date:
November 1, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
University Hospital Ostrava
Agency class:
Other
Source:
University Hospital Ostrava
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06665932
