Radiation CystitisRABBIONCT05246774
Study of Serum and Urinary Biomarkers and Radiation Cystitis in Patients Treated With Radiotherapy for Localized Prostate Cancer
An observational study of Radiation Cystitis and Prostate Cancer, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
Prostate cancer represents the 1st diagnosed cancer in men, with 50400 new cases and 8100 deaths in 2018. Improved diagnostic and therapeutic strategies have led to a 3.7% decrease in mortality between 2010 and 2018 with a 5- and 10-year survival rate of 93% and 80%, respectively. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Radiation Cystitis, Prostate Cancer, Radiotherapy Side Effect
- What is being tested?
- Biological sample collection and Questionnaires
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to Sep 2024
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study population is composed of adult men with localized prostate cancer who are eligible for radiation therapy.
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate;
- Localized adenocarcinoma of the prostate according to the D'Amico Risk Classification for Prostate Cancer;
- Eligible for external beam radiation therapy and/or brachytherapy;
- Patient able, in the opinion of the physician-investigator, to communicate well, understand and comply with the requirements of the study;
- Patient with a phone or a computer.
Who cannot join
- Patient with advanced or metastatic prostate cancer;
- Patient receiving pre-irradiation hormone therapy;
- Patient with bladder or urethral cancer or a history of it;
- Previous urinary tract surgery (bladder augmentation, cystectomy);
- Patient participating in an interventional clinical study;
- Patient with a history of pelvic irradiation;
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, 94160
Carole HELISSEY, MD, 143985000 ext. +33, carole.helissey@intradef.gouv.fr
About this study
Prostate cancer represents the 1st diagnosed cancer in men, with 50400 new cases and 8100 deaths in 2018. Improved diagnostic and therapeutic strategies have led to a 3.7% decrease in mortality between 2010 and 2018 with a 5- and 10-year survival rate of 93% and 80%, respectively.
Pelvic conformal radiotherapy is an important therapeutic technique in the management of pelvic cancers, particularly prostate cancer. However, despite the improvement in radiation techniques, this technique is responsible for acute and late adverse events at the bladder level, these symptoms being grouped under the term radiation cystitis. It has a clear impact on the quality of life of patients. Acute radiation cystitis is likely to occur during treatment or within 3 months after radiotherapy. Its incidence is estimated at nearly 50%. The late form appears on average 2 years after radiation, but can sometimes occur 10 or 20 years later. Its incidence is 5 to 10% of cases.
Read more
Although certain factors have been identified, such as the dose received, fractionation or comorbidities, the pathophysiology of radiation-induced cystitis remains unclear, particularly because of the risks of complications arising from access to bladder tissue post-irradiation, thus limiting our knowledge as well as the therapies targeting this process. The use of biomarkers in liquid biopsies allows us to understand the problem of access to irradiated tissues and to highlight protein changes, prognostic of radiation-induced visceral toxicity.
Few works are published on the evaluation of inflammatory and pro-fibrotic biomarkers of radiation-induced cystitis in liquid biopsies. Only 2 retrospective studies have shown a correlation between late radiation cystitis and increased levels of plasminogen activator inhibitor 1 (PAI-1), matrix metalloproteinase inhibitors (TIMP1 and TIMP2), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF) and placental growth factor (PIGF) in urine. However, none of these studies explored the variation of biomarkers in the early stage of radiation-induced bladder toxicity.
This would suggest the feasibility of prospective assay of overexpression of these proteins in liquid biopsies.
- Being tested
- Biological sample collection, Questionnaires
- Medical subject headings
- Prostatic Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sample collectionBiological
The following biological samples will be collected on 4 occasions (at enrollment, 4 weeks after, 12 weeks after and 52 weeks after) :
- fecal sample
- urinary sample
- blood sample (22 ml at each occasion)
QuestionnairesOther
The following questionnaires will be filled by the patients on 4 occasions (at enrollment, 4 weeks after, 12 weeks after and 52 weeks after) :
- CTCAE Radiation Adverse Event Questionnaire
- Lower Urinary Tract Disorders Questionnaire (IPSS Score)
- Quality of Life Questionnaire (FACT-P)
- Physical Activity Questionnaire (IPAQ)
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of 33 urinary and serum biomarkers potentially related to radiation cystitis between enrollment and 12 weeks after the start of radiotherapy.
The change in expression of the 33 inflammatory and remodeling biomarkers will be assessed by :
- the MILLIPLEX® MAP technique for the analysis of circulating markers
- the flow cytometry method for the analysis of the immune population.
Measured: Up to to 12 weeks after the start of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Mar 2022
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation CystitisStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246774
- Sponsor's protocol ID
- 2021PPRC09
- Other IDs
- 2021-A03196-35
- Acronym
- RABBIO
- Status last verified
- Apr 2023
- First submitted
- 9 Feb 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Helissey C, Cavallero S, Mondot S, Parnot C, Yssaad H, Becherirat S, Guitard N, Thery H, Schernberg A, Breitwiller H, Chargari C, Francois S. Correlation Between Serum and Urine Biomarkers and the Intensity of Acute Radiation Cystitis in Patients Treated With Radiation Therapy for Localized Prostate Cancer: Protocol for the Radiotoxicity Bladder Biomarkers (RABBIO) Study. JMIR Res Protoc. 2023 Jan 10;12:e38362. doi: 10.2196/38362.
PubMed 36626198
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Serum and Urinary Biomarkers and Radiation Cystitis in Patients Treated With Radiotherapy for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT05246774
- Acronym / sponsor ID
- RABBIO / 2021PPRC09
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 18 Feb 2022 (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.
Prostate cancer represents the 1st diagnosed cancer in men, with 50400 new cases and 8100 deaths in 2018. Improved diagnostic and therapeutic strategies have led to a 3.7% decrease in mortality between 2010 and 2018 with a 5- and 10-year survival rate of 93% and 80%, respectively.
Pelvic conformal radiotherapy is an important therapeutic technique in the management of pelvic cancers, particularly prostate cancer. However, despite the improvement in radiation techniques, this technique is responsible for acute and late adverse events at the bladder level, these symptoms being grouped under the term radiation cystitis. It has a clear impact on the quality of life of patients. Acute radiation cystitis is likely to occur during treatment or within 3 months after radiotherapy. Its incidence is estimated at nearly 50%. The late form appears on average 2 years after radiation, but can sometimes occur 10 or 20 years later. Its incidence is 5 to 10% of cases.
Although certain factors have been identified, such as the dose received, fractionation or comorbidities, the pathophysiology of radiation-induced cystitis remains unclear, particularly because of the risks of complications arising from access to bladder tissue post-irradiation, thus limiting our knowledge as well as the therapies targeting this process. The use of biomarkers in liquid biopsies allows us to understand the problem of access to irradiated tissues and to highlight protein changes, prognostic of radiation-induced visceral toxicity.
Few works are published on the evaluation of inflammatory and pro-fibrotic biomarkers of radiation-induced cystitis in liquid biopsies. Only 2 retrospective studies have shown a correlation between late radiation cystitis and increased levels of plasminogen activator inhibitor 1 (PAI-1), matrix metalloproteinase inhibitors (TIMP1 and TIMP2), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF) and placental growth factor (PIGF) in urine. However, none of these studies explored the variation of biomarkers in the early stage of radiation-induced bladder toxicity.
This would suggest the feasibility of prospective assay of overexpression of these proteins in liquid biopsies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is composed of adult men with localized prostate cancer who are eligible for radiation therapy.
Key inclusion criteria (5 listed)
- Histologically confirmed adenocarcinoma of the prostate;
- Localized adenocarcinoma of the prostate according to the D'Amico Risk Classification for Prostate Cancer;
- Eligible for external beam radiation therapy and/or brachytherapy;
- Patient able, in the opinion of the physician-investigator, to communicate well, understand and comply with the requirements of the study;
- Patient with a phone or a computer.
Key exclusion criteria (6 listed)
- Patient with advanced or metastatic prostate cancer;
- Patient receiving pre-irradiation hormone therapy;
- Patient with bladder or urethral cancer or a history of it;
- Previous urinary tract surgery (bladder augmentation, cystectomy);
- Patient participating in an interventional clinical study;
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 |
|---|---|---|
| Biological sample collectionThe following biological samples will be collected on 4 occasions (at enrollment, 4 weeks after, 12 weeks after and 52 weeks after) : * fecal sample * urinary sample * blood sample (22 ml at each occasion) | Biological | – |
| QuestionnairesThe following questionnaires will be filled by the patients on 4 occasions (at enrollment, 4 weeks after, 12 weeks after and 52 weeks after) : * CTCAE Radiation Adverse Event Questionnaire * Lower Urinary Tract Disorders Questionnaire (IPSS Score) * Quality of Life Questionnaire (FACT-P) * Physical Activity Questionnaire (IPAQ) | Other | – |
Primary outcome
Concentration of 33 urinary and serum biomarkers potentially related to radiation cystitis between enrollment and 12 weeks after the start of radiotherapy.
Time frame: Up to to 12 weeks after the start of radiotherapy
The change in expression of the 33 inflammatory and remodeling biomarkers will be assessed by : * the MILLIPLEX® MAP technique for the analysis of circulating markers * the flow cytometry method for the analysis of the immune population.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Derived from this study: PubMed 36626198Helissey C, Cavallero S, Mondot S, Parnot C, Yssaad H, Becherirat S, Guitard N, Thery H, Schernberg A, Breitwiller H, Chargari C, Francois S. Correlation Between Serum and Urine Biomarkers and the Intensity of Acute Radiation Cystitis in Patients Treated With Radiation Therapy for Localized Prostate Cancer: Protocol for the Radiotoxicity Bladder Biomarkers (RABBIO) Study. JMIR Res Protoc. 2023 Jan 10;12:e38362. doi: 10.2196/38362.
- Individual participant dataSharing planned: Undecided
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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.
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 Radiation Cystitis and Prostate Cancer, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
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 5 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: status not confirmed, as of the sponsor's last update on 28 Apr 2023. 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 France. 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 Carole HELISSEY, MD (143985000 ext. +33, carole.helissey@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of 33 urinary and serum biomarkers potentially related to radiation cystitis between enrollment and 12 weeks after the start of radiotherapy. (time frame: Up to to 12 weeks after the start of radiotherapy). 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 NCT05246774, which also lists 1 linked publication.
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 Apr 2023.