Study of Serum and Urinary Biomarkers and Radiation Cystitis in Patients Treated With Radiotherapy for Localized Prostate Cancer

NCT05246774 | Unknown

• 2 other identifiers: 2021PPRC092021-A03196-35
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Radiation Cystitis; Prostate Cancer; Radiotherapy Side Effect

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to to 12 weeks after the start of radiotherapy

Interventions

Biological sample collection BIOLOGICAL

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)

Questionnaires OTHER

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of adult men with localized prostate cancer who are eligible for radiation therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (1)

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, 94160, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 36626198 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Several samples will be collected : * fecal samples * urine samples * blood samples

MeSH Terms

Conditions

Prostatic Neoplasms; Radiation Injuries

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Carole HELISSEY, MD

CONTACT

143985000; carole.helissey@intradef.gouv.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 18, 2022
• Study Start: March 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

FR (1)