Prostate CancerPRO-SPEEDNCT06331013
CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr
A study testing CyberKnife ultra-hypofractionated SBRT in people with Prostate Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
This is a prospective observational study. The study will proceed with the enrollment of 60 patients in 2 years. he aim of the present study is to evaluate effectiveness of ultra-hypofractionated (UH) CyberKnife Stereotactic Body Radiation Therapy treatment on the whole prostate gland plus Simultaneous integrated… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- CyberKnife ultra-hypofractionated SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2023to 31 Dec 2029
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 and < 80 years
- Histologically confirmed adenocarcinoma of the prostate
- Low, Intermediate and high-risk category according to NCCN version 02.2021
- Clinically node negative and no distant metastasis
- Eastern Cooperative Oncology Group (ECOG) Performance Status <2
- Good urinary flow (peak flow >10 mL/s) or IPSS < 15
Show all 10Show fewer
- Prostate volume < 100 cc
- Available mpMRI of the prostate
- Less than 3 DILs at mpMRI (if >2 DILs, only DILs with higher Prostate Imaging - Reporting and Data System (PIRADS) will be included and only PI-RADS >2)
- Written informed consent for treatment and research purpose
Who cannot join
- platelets count < 75000
- urethral stricture
- Previous pelvic RT
- Concomitant inflammatory bowel disease or other serious systemic comorbidities
- Previous prostatectomy
- Presence of hip prosthesis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan
Barbara Alicja Jereczek
About this study
Official title: CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr With Dose-escalation to the Dominant Intraprostatic Lesion: is the Juice Worth the Squeeze? The PRO-SPEED Trial
This is a prospective observational study. The study will proceed with the enrollment of 60 patients in 2 years. he aim of the present study is to evaluate effectiveness of ultra-hypofractionated (UH) CyberKnife Stereotactic Body Radiation Therapy treatment on the whole prostate gland plus Simultaneous integrated boost (SIB) to the dominant intraprostatic lesions (DIL(s) in intermediate-unfavourable to high-risk Prostate Cancer (PCa) patients.
Read the detailed description
The patient to be enrolled in the prospective observational phase will be screened at first visit; prescription of Prostate Specific Antigen (PSA) and testosterone analysis, uroflowmetry and multiparametric Magnetic Resonance Imaging (mpMRI) are mandatory if not already done.
Additional staging imaging (computed tomography (CT) and/or bone scan) will be required according to National Comprehensive Cancer Network (NCCN) category risk group.
Subsequently, for the eligible patient, the enrollment phase involves eco-guided transrectal insertion of 3-4 gold fiducials in the prostate gland.
CT with full bladder and empty rectum will be done after 7-10 days from fiducials insertion; CyberKnife-Stereotactic Body Radiation Therapy (SBRT) treatment will start after 5-7 days from the simulation CT. A total of 36.25 Gy to the prostate gland will be executed in 5 alternate days. For each treatment delivery, the patient is required to be prepared in roughly the same bladder and rectum filling condition of the simulation day. Finally, in the last treatment day QoL and both clinician- and patient-reported genitourinary (GU) and gastrointestinal (GI) acute toxicity assessment is required.
- Conditions
- Prostate Cancer
- Being tested
- CyberKnife ultra-hypofractionated SBRT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberKnife ultra-hypofractionated SBRTRadiation
CyberKnife ultra-hypofractionated SBRT for localized Prostate cancer with dose-escalation to the dominant intraprostatic lesion
| Study group | Role | What they receive |
|---|---|---|
| CyberKnife SBRT treatment | Experimental | CyberKnife ultra-hypofractionated SBRT for localized Prostate cancer with dose-escalation to the dominant intraprostatic lesion Receives: Radiation: CyberKnife ultra-hypofractionated SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Acute GU and GI toxicities (RTOG)
Evaluation of acute genitourinary and gastrointestinal toxicity using Radiation Toxicity Grading (RTOG) distinguishing between lower toxicities (G1 and G2) and worse toxicities (G3 and G4)
Measured: 3 months
Number of Participants with Late GU and GI toxicities (RTOG)
Evaluation of late genitourinary and gastrointestinal toxicity using Radiation Toxicity Grading (RTOG) distinguishing between lower toxicities (G1 and G2) and worse toxicities (G3 and G4)
Measured: 24 months
Evaluation of patient-reported toxicity
Evaluation of patient-reported toxicity using International Prostatic Symptoms Score IPSS
Measured: 24 months
Evaluation of patient-reported quality of life
Evaluation of patient-reported toxicity using International Index of Erectile Function Questionnaire
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start20 Feb 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Alicja Jereczek, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331013
- Sponsor's protocol ID
- IEO 1872
- Acronym
- PRO-SPEED
- Status last verified
- Aug 2025
- First submitted
- 13 Mar 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr With Dose-escalation to the Dominant Intraprostatic Lesion: is the Juice Worth the Squeeze? The PRO-SPEED Trial
- ClinicalTrials.gov ID
- NCT06331013
- Acronym / sponsor ID
- PRO-SPEED / IEO 1872
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 Mar 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.
This is a prospective observational study. The study will proceed with the enrollment of 60 patients in 2 years. he aim of the present study is to evaluate effectiveness of ultra-hypofractionated (UH) CyberKnife Stereotactic Body Radiation Therapy treatment on the whole prostate gland plus Simultaneous integrated boost (SIB) to the dominant intraprostatic lesions (DIL(s) in intermediate-unfavourable to high-risk Prostate Cancer (PCa) patients.
Detailed description
The patient to be enrolled in the prospective observational phase will be screened at first visit; prescription of Prostate Specific Antigen (PSA) and testosterone analysis, uroflowmetry and multiparametric Magnetic Resonance Imaging (mpMRI) are mandatory if not already done.
Additional staging imaging (computed tomography (CT) and/or bone scan) will be required according to National Comprehensive Cancer Network (NCCN) category risk group.
Subsequently, for the eligible patient, the enrollment phase involves eco-guided transrectal insertion of 3-4 gold fiducials in the prostate gland.
CT with full bladder and empty rectum will be done after 7-10 days from fiducials insertion; CyberKnife-Stereotactic Body Radiation Therapy (SBRT) treatment will start after 5-7 days from the simulation CT. A total of 36.25 Gy to the prostate gland will be executed in 5 alternate days. For each treatment delivery, the patient is required to be prepared in roughly the same bladder and rectum filling condition of the simulation day. Finally, in the last treatment day QoL and both clinician- and patient-reported genitourinary (GU) and gastrointestinal (GI) acute toxicity assessment is required.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CyberKnife SBRT treatment | Experimental | Radiation: CyberKnife ultra-hypofractionated SBRTCyberKnife ultra-hypofractionated SBRT for localized Prostate cancer with dose-escalation to the dominant intraprostatic lesion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18 and < 80 years
- Histologically confirmed adenocarcinoma of the prostate
- Low, Intermediate and high-risk category according to NCCN version 02.2021
- Clinically node negative and no distant metastasis
- Eastern Cooperative Oncology Group (ECOG) Performance Status <2
Key exclusion criteria (6 listed)
- platelets count < 75000
- urethral stricture
- Previous pelvic RT
- Concomitant inflammatory bowel disease or other serious systemic comorbidities
- Previous prostatectomy
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 |
|---|---|---|
| CyberKnife ultra-hypofractionated SBRTCyberKnife ultra-hypofractionated SBRT for localized Prostate cancer with dose-escalation to the dominant intraprostatic lesion | Radiation | CyberKnife SBRT treatment |
Primary outcome
Number of Participants with Acute GU and GI toxicities (RTOG)
Time frame: 3 months
Evaluation of acute genitourinary and gastrointestinal toxicity using Radiation Toxicity Grading (RTOG) distinguishing between lower toxicities (G1 and G2) and worse toxicities (G3 and G4)
Number of Participants with Late GU and GI toxicities (RTOG)
Time frame: 24 months
Evaluation of late genitourinary and gastrointestinal toxicity using Radiation Toxicity Grading (RTOG) distinguishing between lower toxicities (G1 and G2) and worse toxicities (G3 and G4)
Evaluation of patient-reported toxicity
Time frame: 24 months
Evaluation of patient-reported toxicity using International Prostatic Symptoms Score IPSS
Evaluation of patient-reported quality of life
Time frame: 24 months
Evaluation of patient-reported toxicity using International Index of Erectile Function Questionnaire
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 28 Aug 2025.
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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.
Barbara Alicja Jereczek principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyberKnife ultra-hypofractionated SBRT in people with Prostate Cancer, run by European Institute of Oncology at 1 site in Italy.
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 10 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 28 Aug 2025. 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 Italy. 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 Barbara Alicja Jereczek, MD (+39 0257489037, barbara.jereczek@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Acute GU and GI toxicities (RTOG) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.