Prostate CancerNCT03284151
Focused Stereotactic Radiation Treatment of Prostatic Adenocarcinoma
An observational study of Prostate Cancer, run by Centre Francois Baclesse, Luxembourg at 1 site in Luxembourg.
Trial summary
Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Cyberknife
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteLuxembourg
- Study dates
- Jan 2015to Jan 2023
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prostatic adenocarcinoma Capra≤2
Who may be able to join
- Prostatic adenocarcinoma of Capra score≤2 invading no more than two adjacent of the 12 prostatic zones. Lesions>3mm. Maximal urinary flow rate ≥ 10ml/s, mean flow rate ≥ 5ml/s, post micturation volume ≤80ml, IPSS score ≤15.
Who cannot join
- systemic disease, ulcerative hemorrhagic ulcer or Crohn diseases, bladder neck stenosis, urethral implants, transurethral prostatectomy (TURP), any recurrent prostatitis within the last 3 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robotic and Focused Stereotactic Radiation Treatment of Good Prognosis Prostatic Adenocarcinoma
Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.
Read the detailed description
Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.
Second objectives : objectives: prostate-specific antigen (PSA) response, MRI response, toxicity (CTCAEv4), quality of life (International Prostate Symptom Score (IPSS) and The International Index of Erectile Function (IIEF5) scores).
Method At first: Multiparametric Magnetic resonance imaging (MRI) - 12 biopsies within the whole gland.
Placement under endorectal ultrasound control of 4 fiducials at least 2 cm spaced.
Treatment : CyberKnife radiation treatment delivering 36.25 Gy in 5 fractions, in 10 days. Tracking using the 4 fiducials. Critical organs: Rectal and bladder wall: V35<2cc. Bladder neck and urethra: V35<1cc.
Salvage treatments: in such a context, salvage surgery or salvage intensity modulation radiation therapy (IMRT) treatments can in theory remain valid and safe options.
- Conditions
- Prostate Cancer
- Being tested
- Cyberknife
- Keywords
- prostate cancer, good prognosis, focused treatment, 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.
CyberknifeRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay between the initial diagnosis and date of salvage treatment
Delay between the initial diagnosis and date of salvage treatment
Measured: through study completion, up to 36 months
Secondary outcomes (5)
PSA evaluation
PSA dosage
Measured: 3, 6, 12, 18, 24, 30, 36 months
Birads score evaluation
Multiparametric prostatic MRI
Measured: 12, 24, 36 months
Acute and late toxicity
Acute and late toxicity using the CTCAEv4
Measured: 3, 6, 12, 18, 24, 30, 36 months
IPSS evaluation
IPSS score
Measured: 12, 24, 36 months
IIEF5 evaluation
IIEF5 score
Measured: 12, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study startJan 2015
- Primary completionJan 2020
- Study completionJan 2023 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 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
- NCT03284151
- Sponsor's protocol ID
- CYM6 Prostate CFB2
- Status last verified
- Jun 2022
- First submitted
- 7 Sep 2017
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
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 and Focused Stereotactic Radiation Treatment of Good Prognosis Prostatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03284151
- Acronym / sponsor ID
- CYM6 Prostate CFB2
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, good prognosis, focused treatment, Cyberknife
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Francois Baclesse, LuxembourgUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2023 (estimated)
- First posted
- 15 Sep 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.
Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.
Detailed description
Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.
Second objectives : objectives: prostate-specific antigen (PSA) response, MRI response, toxicity (CTCAEv4), quality of life (International Prostate Symptom Score (IPSS) and The International Index of Erectile Function (IIEF5) scores).
Method At first: Multiparametric Magnetic resonance imaging (MRI) - 12 biopsies within the whole gland.
Placement under endorectal ultrasound control of 4 fiducials at least 2 cm spaced.
Treatment : CyberKnife radiation treatment delivering 36.25 Gy in 5 fractions, in 10 days. Tracking using the 4 fiducials. Critical organs: Rectal and bladder wall: V35<2cc. Bladder neck and urethra: V35<1cc.
Salvage treatments: in such a context, salvage surgery or salvage intensity modulation radiation therapy (IMRT) treatments can in theory remain valid and safe options.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prostatic adenocarcinoma Capra≤2
Key inclusion criteria (1 listed)
- Prostatic adenocarcinoma of Capra score≤2 invading no more than two adjacent of the 12 prostatic zones. Lesions>3mm. Maximal urinary flow rate ≥ 10ml/s, mean flow rate ≥ 5ml/s, post micturation volume ≤80ml, IPSS score ≤15.
Key exclusion criteria (1 listed)
- systemic disease, ulcerative hemorrhagic ulcer or Crohn diseases, bladder neck stenosis, urethral implants, transurethral prostatectomy (TURP), any recurrent prostatitis within the last 3 years.
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 | Radiation | – |
Primary outcome
Delay between the initial diagnosis and date of salvage treatment
Time frame: through study completion, up to 36 months
Delay between the initial diagnosis and date of salvage treatment
5 secondary outcomes
PSA evaluation
Time frame: 3, 6, 12, 18, 24, 30, 36 months
Birads score evaluation
Time frame: 12, 24, 36 months
Acute and late toxicity
Time frame: 3, 6, 12, 18, 24, 30, 36 months
IPSS evaluation
Time frame: 12, 24, 36 months
IIEF5 evaluation
Time frame: 12, 24, 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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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 1 inclusion and 1 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 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?
Results are not available in the source record.
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?
Delay between the initial diagnosis and date of salvage treatment (time frame: through study completion, up to 36 months). 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 22 Jun 2022.