Prostate Cancer (Adenocarcinoma)NCT06665932
Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins
A study testing Stereotactic radiotherapy in people with Prostate Cancer (Adenocarcinoma), run by University Hospital Ostrava at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- Stereotactic radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- age over 18 years
- signed informed consent form
- suitable position of fiducials (to be determined by the physicist)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Zuzana Zděblová-Čermáková, MD, Ph.D.
About this study
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.
Read the 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)
- Being tested
- Stereotactic radiotherapy
- Keywords
- prostate cancer, Stereotactic Body Radiotherapy, acute toxicity, late toxicity
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic radiotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Men with prostate cancer | Experimental | Not described Receives: Procedure: Stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 months from treatment
Secondary outcomes (3)
5-year cumulative toxicity
5-year cumulative toxicity (urological and lower GIT) according to the CTCAE 4.03 scale
Measured: 5 years
Quality of Life according to the EPIC-26 scale
Quality of Life will be assessed using the Expanded Prostate Cancer Index Composite (EPIC-26) scale
Measured: 5 years from treatment
Quality of life (EQ-5D)
Quality of Life will be assessed using the EQ-5D tool
Measured: 5 years from treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665932
- Sponsor's protocol ID
- ONK-11-SBRT
- Other IDs
- 16/RVO-FNOs/2024
- Status last verified
- Nov 2024
- First submitted
- 29 Oct 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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.
PubMed 36633877Dearnaley 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.
PubMed 17482880
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins
- ClinicalTrials.gov ID
- NCT06665932
- Acronym / sponsor ID
- ONK-11-SBRT
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- prostate cancer, Stereotactic Body Radiotherapy, acute toxicity, late toxicity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men with prostate cancer | Experimental | Procedure: Stereotactic radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic radiotherapyStereotactic 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. | Procedure or surgery | Men with prostate cancer |
Primary outcome
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
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Background: PubMed 36633877Kishan 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.
- Background: PubMed 17482880Dearnaley 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.
- Individual participant dataSharing planned: Undecided. There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic radiotherapy in people with Prostate Cancer (Adenocarcinoma), run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicity incidence (time frame: 3 months from treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06665932, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.