Influence of Hormone Treatment in Radiation Therapy for Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT04282876|
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : August 8, 2022
|Condition or disease||Intervention/treatment|
|Bladder Cancer Radiation Therapy Complication Quality of Life||Drug: Degarelix|
Bladder cancer (BC) is one of the most frequent cancers in the world and more common in men than female. Gender-related factors may be involved in the pathogenesis of BC.
Studies have suggested that androgen-receptors may be present in the bladder and potentially involved in BC aetiology, thus making BC susceptible for androgen deprivation therapy (ADT).
Currently treatment for BC includes surgery or radiation therapy. ADT include Degarelix, which besides decreasing testosterone, has been shown to reduce the occurrence of BC in rats and promote stem cell recovery following radiation therapy.
Hypothesis ADT will lower the incidence of BC, and the prognosis of BC will vary depending on the type of ADT used. Furthermore Degarelix administered during radiation therapy for BC will reduce the degree of fibrosis in the bladder thus decreasing adverse side effects.
Methods A cohort of patients treated with ADT for PC will be compared to two cohorts of age-matched men with and without PC both without ADT. The incidence of BC will be recorded for every group. Furthermore the cohort of patients with PC and ADT will be divided into subgroups, depending of the type of ADT they have received and the degree of deprivation. They will be compared in terms of incidence and prognosis of BC.
Finally, a small pilot study will be conducted to investigate the effect of Degarelix when administered during radiation therapy for BC.
Perspectives This will be one of the largest studies to investigate the potential influence of sex hormones in the development and prognosis of BC and potentially lead to new treatment options and possibly a new way of reducing radiation side effects.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Influence of Hormone Treatment in Radiation Therapy for Bladder Cancer|
|Actual Study Start Date :||February 19, 2020|
|Estimated Primary Completion Date :||February 1, 2024|
|Estimated Study Completion Date :||October 31, 2025|
Patients undergoing radiation therapy for bladder cancer while also being treated with Degarelix (androgen deprivation therapy)
Patients receiving Degarelix
Patients undergoing radiation therapy for bladder cancer with or without simultanous treatment with androgen deprivation therapy (not Degarelix)
- Bladder fibrosis [ Time Frame: 3 months after radiation ]Fibrosis of the bladder determined by bladder biopsy estimated by number of fibrotic fibers on IHC staining
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282876
|Contact: Jørgen Jensen, Professoremail@example.com|
|Aarhus University Hospital||Recruiting|
|Aarhus, Denmark, 8200|
|Contact: Jørgen Bjerggaard Jensen, MD +45 30915682 firstname.lastname@example.org|