Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins

NCT ID: NCT06665932

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2027-12-31

Brief 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).

Conditions

Prostate Cancer (Adenocarcinoma)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Men with prostate cancer

Group Type: EXPERIMENTAL

Stereotactic radiotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Ostrava

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Jiří Hynčica

Role: CONTACT

jiri.hyncica@fno.cz

0042059737 ext. 2587

Facility Contacts

Jiří Hynčica

Role: primary

jiri.hyncica@fno.cz

0042059737 ext. 2587

References

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.

Reference Type: BACKGROUND

PMID: 36633877 (View on PubMed)

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/S1470-2045(07)70143-2.

Reference Type: BACKGROUND

PMID: 17482880 (View on PubMed)

Other Identifiers

16/RVO-FNOs/2024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ONK-11-SBRT

Identifier Type: -

Identifier Source: org_study_id