Prostate CancerCYBERPROSTNCT03225235
Prospective Evaluation of Hypofractionated Stereotactic RT Using CyberKnife for Patients With Prostate Cancer
A study testing SBRT in people with Prostate Cancer, run by The Greater Poland Cancer Centre at 1 site in Poland.
Trial summary
The main purpose of study is to evaluate hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients with low and intermediate risk of progression prostate cancer. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 sitePoland
- Study dates
- 26 Aug 2013to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men from 40 to 75 years of age with a confirmed adenocarcinoma prostate, prostate biopsy will be performed <180 days prior to the randomization date,
- completed assessment of tumor differentiation according to Gleason grading allows to perform stratification;
- general Performance Status according to the Eastern Cooperative Oncology Group (ECOG) classification ( 0 -1),
- belonging to the group of low and intermedium risk of progression; (cT1-cT2c, Gleason 7, PSA to 19.9 ng / ml), cT specified by AJCC 7 Edition (appendix 2),
- PSA marked at least 10 days after or before the biopsy, and for patients taking phytosterol 30 days after discontinuation,
- no distant metastases,
- signing informed consent,
- morphological and biochemical blood parameters within the normal limits.
Who cannot join
- the presence of active cancer, except skin cancer preceding period 5 years prior to randomization,
- surgical treatment (radical prostatectomy) or RT in the pelvic area,
- co-morbidities that may significantly affect the expectancy life of the patients
- do not meet the criteria for inclusion.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Greater Poland Cancer Centre
Poznan, Wielkopolska, 61-866
Piotr Milecki, MD PhD, +48 61 885 08 78, piotr.milecki@wco.pl
Sylwia Krąkowska, MA, +48 61 885 08 78, sylwia.krakowska@wco.pl
About this study
Official title: Prospective Evaluation of Hypofractionated Stereotactic RT (SBRT) Using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer.
The main purpose of study is to evaluate hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients with low and intermediate risk of progression prostate cancer.
Read the detailed description
Evaluation of the usefulness expression of selected proteins (PTEN, SMAD4, Cyclin D1, SPP1) as prognostic and predictive factors.
- Conditions
- Prostate Cancer
- Being tested
- SBRT
- Keywords
- Prostate cancer, SBRT, Ultrafractionation, CyberKnife
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Stereotactic SBRT | Experimental | By assuming a hypofractionated irradiation scheme, it is assumed that between the fractions sublethal radiation damage is being treated and the time factor does not significantly affect RT result. The SBRT fractional dose was determined on the basis of a Biologically Effective Dose (BED) calculation using a linear-square model, which assumes that α / β takes the following values for:
* tumor (RS) = 1.5
* Late rectal and bladder complications = 3.0
* early rectal and bladder complications = 10.0. Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival time without biochemical recurrence,
Phoenix definition of biochemical failure
Measured: 5 years
Secondary outcomes (1)
survival time specific for prostate cancer,
the period of time from randomization until death from prostate cancer
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start26 Aug 2013
- Primary completionDec 2020 (estimated)
- Study completionAug 2025 (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.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Greater Poland Cancer Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Milecki, PhD., MD, Principal investigator, Greater Poland Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225235
- Sponsor's protocol ID
- CYBERPROST
- Acronym
- CYBERPROST
- Status last verified
- Feb 2020
- First submitted
- 19 May 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Hypofractionated Stereotactic RT (SBRT) Using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer.
- ClinicalTrials.gov ID
- NCT03225235
- Acronym / sponsor ID
- CYBERPROST / CYBERPROST
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, SBRT, Ultrafractionation, CyberKnife
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The Greater Poland Cancer CentreUniversity, hospital or other
- Study start
- 26 Aug 2013 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 21 Jul 2017 (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 main purpose of study is to evaluate hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients with low and intermediate risk of progression prostate cancer.
Detailed description
Evaluation of the usefulness expression of selected proteins (PTEN, SMAD4, Cyclin D1, SPP1) as prognostic and predictive factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Stereotactic SBRT | Experimental | Radiation: SBRTBy assuming a hypofractionated irradiation scheme, it is assumed that between the fractions sublethal radiation damage is being treated and the time factor does not significantly affect RT result. The SBRT fractional dose was determined on the basis of a Biologically Effective Dose (BED) calculation using a linear-square model, which assumes that α / β takes the following values for: * tumor (RS) = 1.5 * Late rectal and bladder complications = 3.0 * early rectal and bladder complications = 10.0. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- men from 40 to 75 years of age with a confirmed adenocarcinoma prostate, prostate biopsy will be performed <180 days prior to the randomization date,
- completed assessment of tumor differentiation according to Gleason grading allows to perform stratification;
- general Performance Status according to the Eastern Cooperative Oncology Group (ECOG) classification ( 0 -1),
- belonging to the group of low and intermedium risk of progression; (cT1-cT2c, Gleason 7, PSA to 19.9 ng / ml), cT specified by AJCC 7 Edition (appendix 2),
- PSA marked at least 10 days after or before the biopsy, and for patients taking phytosterol 30 days after discontinuation,
Key exclusion criteria (4 listed)
- the presence of active cancer, except skin cancer preceding period 5 years prior to randomization,
- surgical treatment (radical prostatectomy) or RT in the pelvic area,
- co-morbidities that may significantly affect the expectancy life of the patients
- do not meet the criteria for inclusion.
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 |
|---|---|---|
| SBRThypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer | Radiation | Hypofractionated Stereotactic SBRT |
Primary outcome
survival time without biochemical recurrence,
Time frame: 5 years
Phoenix definition of biochemical failure
1 secondary outcome
survival time specific for prostate cancer,
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Piotr Milecki, PhD., MD principal investigator
Greater Poland Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT in people with Prostate Cancer, run by The Greater Poland Cancer Centre at 1 site in Poland.
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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Feb 2020. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piotr Milecki, PhD., MD (+48618850878, piotr.milecki@wco.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival time without biochemical recurrence, (time frame: 5 years). 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 5 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.