Prostate CancerProRobotNCT03235557
CyberKnife for Prostate Cancer Patients Aged 70 y or More
An observational study of Prostate Cancer, run by Centre Francois Baclesse, Luxembourg at 1 site in Luxembourg.
Trial summary
Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly. Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA (Prostate Specific Antigen) <30ng/ml. Read more about this study
- Who is it for?
- Ages 70 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 150 participants
- Where
- 1 siteLuxembourg
- Study dates
- Oct 2014to Dec 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 70 years and older
- Men only
- No healthy volunteers
- Older adult
Study population: Elderly patients suffering prostatic adenocarcinoma
Who may be able to join
- T1-T3b,
- MRI pelvic nodes negative,
- M0,
- any Gleason Score,
- PSA<30ng/ml,
- WHO (World Health Organisation) score<2, IPSS≤15,
Show all 9Show fewer
- maximal urinary flow rate ≥15ml/s,
- mean urinary flow rate ≥5ml/s,
- multiparametric prostatic and pelvis MRI
Who cannot join
- Prostatic volume > 100cc,
- TURP (transurethral prostatectomy) <3 y,
- any recurrent prostatitis within the last 3 years,
- collagenose diseases,
- ulcero-haemorrhagic rectocolitis or
- crohn diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robotic Radiation Treatment of Prostate Cancer Patients Aged 70 y or More
Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly.
Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA (Prostate Specific Antigen) <30ng/ml.
Dose : 36.25 Gy in 5 fractions, in 10 days, considering CAPRA Scores≤5 AND 37.5 Gy in 5 fractions, in 10 days, considering CAPRA Scores>5.
Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives : PSA and MRI response.
Read the detailed description
Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly.
Rationale : Half of the prostatic adenocarcinoma are diagnosed in the elderly but until now curative treatments were not proven to increase overall survival rates. Therefore, very short, comfortable and safe treatments have to be designed to increase the pelvic control of the disease. Moreover, the alpha/beta ratio of the disease ≤3Gray is in favour of using hypofractionation schemes.
Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives : PSA and MRI response and quality of life evaluation.
Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA<30ng/ml.
Dose : 36.25 Gray in 5 fractions, in 10 days, considering CAPRA Score≤5 AND 37.5 Gray in 5 fractions, in 10 days, considering CAPRA Scores>5.
Doses to the Organs At Risk (OAR) : Rectum wall : V36.25<2%, V27<20%, V23<30%, V20<35%. Bladder wall : V36.25<2%, V27<20%, V20<35%. Considering specifically the prescription of 37.5 Gray, the rectum and bladder wall: V37.5<2%. Anytime, hot spots of 105 % of the prescription dose must avoid the urethra.
Evaluation criteria : CTCAEV4 (Common Toxicity Criteria for Adverse Events, version4), PSA, multiparametric MRI, IPSS (International Prostate Score Symptom) and IIEF5 (International Index of Erectile Function).
Methodolgy : this is a three step prospective, observational study of 20 patients each step. Before moving to the next step, the severe acute or late toxicity at a median follow-up of 1 year must remain below 5% each.
- Conditions
- Prostate Cancer
- Keywords
- prostate, cancer, radiation, stereotactic, CyberKnife, elderly
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute and late toxicity (Using the CTCAEv4)
Using the CTCAEv4
Measured: During 36 months after treatment
Secondary outcomes (5)
PSA evaluation
PSA Dosage
Measured: at 4 and 6 months, than every 6 months for 3 years
Digital rectal exam
Clinical examination (digital rectal exam)
Measured: at 6, 12, 24 and 36 months
Birads score evaluation
Multiparametric prostatic MRI
Measured: at 36 months
IPSS evaluation
IPSS score
Measured: at 12, 24 and 36 months
IIEF5 evaluation
IIEF5 score
Measured: at 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study startOct 2014
- Primary completionOct 2018
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse, Luxembourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Nickers, MD, PhD, Study chair, Centre Francois BaclesseMichel Untereiner, MD, Study director, Centre Francois Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235557
- Sponsor's protocol ID
- CYM Prostate CFB 1
- Acronym
- ProRobot
- Status last verified
- Jun 2022
- First submitted
- 15 Jan 2015
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nickers P, Hermesse J, Deneufbourg JM, Vanbelle S, Lartigau E. Which alpha/beta ratio and half-time of repair are useful for predicting outcomes in prostate cancer? Radiother Oncol. 2010 Dec;97(3):462-6. doi: 10.1016/j.radonc.2010.06.006. Epub 2010 Aug 17.
PubMed 20724012Boike TP, Lotan Y, Cho LC, Brindle J, DeRose P, Xie XJ, Yan J, Foster R, Pistenmaa D, Perkins A, Cooley S, Timmerman R. Phase I dose-escalation study of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer. J Clin Oncol. 2011 May 20;29(15):2020-6. doi: 10.1200/JCO.2010.31.4377. Epub 2011 Apr 4.
PubMed 21464418King CR, Brooks JD, Gill H, Presti JC Jr. Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):877-82. doi: 10.1016/j.ijrobp.2010.11.054. Epub 2011 Feb 6.
PubMed 21300474
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Radiation Treatment of Prostate Cancer Patients Aged 70 y or More
- ClinicalTrials.gov ID
- NCT03235557
- Acronym / sponsor ID
- ProRobot / CYM Prostate CFB 1
- Conditions
- Prostate Cancer
- Keywords
- prostate, cancer, radiation, stereotactic, CyberKnife, elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Francois Baclesse, LuxembourgUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2018 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 1 Aug 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.
Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly.
Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA (Prostate Specific Antigen) <30ng/ml.
Dose : 36.25 Gy in 5 fractions, in 10 days, considering CAPRA Scores≤5 AND 37.5 Gy in 5 fractions, in 10 days, considering CAPRA Scores>5.
Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives : PSA and MRI response.
Detailed description
Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly.
Rationale : Half of the prostatic adenocarcinoma are diagnosed in the elderly but until now curative treatments were not proven to increase overall survival rates. Therefore, very short, comfortable and safe treatments have to be designed to increase the pelvic control of the disease. Moreover, the alpha/beta ratio of the disease ≤3Gray is in favour of using hypofractionation schemes.
Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives : PSA and MRI response and quality of life evaluation.
Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA<30ng/ml.
Dose : 36.25 Gray in 5 fractions, in 10 days, considering CAPRA Score≤5 AND 37.5 Gray in 5 fractions, in 10 days, considering CAPRA Scores>5.
Doses to the Organs At Risk (OAR) : Rectum wall : V36.25<2%, V27<20%, V23<30%, V20<35%. Bladder wall : V36.25<2%, V27<20%, V20<35%. Considering specifically the prescription of 37.5 Gray, the rectum and bladder wall: V37.5<2%. Anytime, hot spots of 105 % of the prescription dose must avoid the urethra.
Evaluation criteria : CTCAEV4 (Common Toxicity Criteria for Adverse Events, version4), PSA, multiparametric MRI, IPSS (International Prostate Score Symptom) and IIEF5 (International Index of Erectile Function).
Methodolgy : this is a three step prospective, observational study of 20 patients each step. Before moving to the next step, the severe acute or late toxicity at a median follow-up of 1 year must remain below 5% each.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 70 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients suffering prostatic adenocarcinoma
Key inclusion criteria (9 listed)
- T1-T3b,
- MRI pelvic nodes negative,
- M0,
- any Gleason Score,
- PSA<30ng/ml,
Key exclusion criteria (6 listed)
- Prostatic volume > 100cc,
- TURP (transurethral prostatectomy) <3 y,
- any recurrent prostatitis within the last 3 years,
- collagenose diseases,
- ulcero-haemorrhagic rectocolitis or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute and late toxicity (Using the CTCAEv4)
Time frame: During 36 months after treatment
Using the CTCAEv4
5 secondary outcomes
PSA evaluation
Time frame: at 4 and 6 months, than every 6 months for 3 years
Digital rectal exam
Time frame: at 6, 12, 24 and 36 months
Birads score evaluation
Time frame: at 36 months
IPSS evaluation
Time frame: at 12, 24 and 36 months
IIEF5 evaluation
Time frame: at 12, 24 and 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Results publication: PubMed 20724012Nickers P, Hermesse J, Deneufbourg JM, Vanbelle S, Lartigau E. Which alpha/beta ratio and half-time of repair are useful for predicting outcomes in prostate cancer? Radiother Oncol. 2010 Dec;97(3):462-6. doi: 10.1016/j.radonc.2010.06.006. Epub 2010 Aug 17.
- Results publication: PubMed 21464418Boike TP, Lotan Y, Cho LC, Brindle J, DeRose P, Xie XJ, Yan J, Foster R, Pistenmaa D, Perkins A, Cooley S, Timmerman R. Phase I dose-escalation study of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer. J Clin Oncol. 2011 May 20;29(15):2020-6. doi: 10.1200/JCO.2010.31.4377. Epub 2011 Apr 4.
- Results publication: PubMed 21300474King CR, Brooks JD, Gill H, Presti JC Jr. Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):877-82. doi: 10.1016/j.ijrobp.2010.11.054. Epub 2011 Feb 6.
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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.
Philippe Nickers, MD, PhD study chair
Centre Francois Baclesse
Michel Untereiner, MD study director
Centre Francois Baclesse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Centre Francois Baclesse, Luxembourg at 1 site in Luxembourg.
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: finished, as of the sponsor's last update on 22 Jun 2022. 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 Luxembourg. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute and late toxicity (Using the CTCAEv4) (time frame: During 36 months after treatment). 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 NCT03235557, which also lists 3 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 22 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.