Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins

NCT06665932 | Recruiting

• 2 other identifiers: ONK-11-SBRT16/RVO-FNOs/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

prostate cancer; Stereotactic Body Radiotherapy; acute toxicity; late toxicity

Outcome Measures

Primary Outcomes (2)

• 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

  3 months from treatment

• 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

  3 months from treatment

Secondary Outcomes (3)

• 5-year cumulative toxicity

  5 years

• Quality of Life according to the EPIC-26 scale

  5 years from treatment

• Quality of life (EQ-5D)

  5 years from treatment

Study Arms (1)

Men with prostate cancer

EXPERIMENTAL

Procedure: Stereotactic radiotherapy

Interventions

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.

Men with prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only male patients with prostate cancer will be enrolled in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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.

  PMID: 17482880 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

CZ (1)