Hormone treatment's effect on bladder cancer radiation therapy
Influence of Hormone Treatment in Radiation Therapy for Bladder Cancer
This study is testing whether a hormone treatment called Degarelix can help bladder cancer patients feel better and recover more easily while they receive radiation therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Aarhus University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT04282876 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of androgen deprivation therapy (ADT) on patients undergoing radiation therapy for bladder cancer. It aims to determine whether administering Degarelix, a type of ADT, during radiation can protect bladder stem cells and improve recovery, thereby reducing side effects and enhancing quality of life. The study will compare a cohort of patients receiving ADT with two age-matched cohorts without ADT, assessing the incidence and prognosis of bladder cancer across these groups. Additionally, a pilot study will explore the specific effects of Degarelix during radiation therapy.
Who should consider this trial
Good fit: Ideal candidates include men with T2-T4 bladder cancer who are scheduled to receive radiation therapy and can complete questionnaires.
Not a fit: Patients with metastatic disease or significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer side effects and improved quality of life for bladder cancer patients undergoing radiation therapy.
How similar studies have performed: While there is some preliminary evidence suggesting the benefits of ADT in bladder cancer treatment, this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * T2-T4 bladder cancer * radiation therapy * able to fill out questionnaires * signed informed consent Exclusion Criteria: * KAD prior to TUR-B * dementia or other cognitive impairment * metastatic disease
Where this trial is running
Aarhus
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Study coordinator: Jørgen Jensen, Professor
- Email: bjerggaard@skejby.rm.dk
- Phone: 30915525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.