Influence of Hormone Treatment in Radiation Therapy for Bladder Cancer

NCT ID: NCT04282876

Last Updated: 2022-08-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-19
• Study Completion Date: 2025-10-31

Brief Summary

Bladder cancer is often treated with cystectomy or radiation therapy. Following radiation therapy patients will often have severe side effects from the treatment. Studies have suggested that simultanously treatment with androgen deprivation therapy during radiation therapy may be able to proctect stemcells in the bladder, thus improving tissue recovering post-radiation, which would result in improved bladder compliance following the treatment and ultimately result in fewer side effects and overall improved patient quality of life.

Detailed Description

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.

Conditions

Bladder Cancer; Radiation Therapy Complication; Quality of Life

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Degarelix

Patients undergoing radiation therapy for bladder cancer while also being treated with Degarelix (androgen deprivation therapy)

Degarelix

Intervention Type: DRUG

Patients receiving Degarelix

Control

Patients undergoing radiation therapy for bladder cancer with or without simultanous treatment with androgen deprivation therapy (not Degarelix)

No interventions assigned to this group

Interventions

Degarelix

Patients receiving Degarelix

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jørgen Bjerggaard Jensen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aarhus University Hospital

Aarhus, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Jørgen Jensen, Professor

Role: CONTACT

bjerggaard@skejby.rm.dk

30915525

Facility Contacts

Jørgen Bjerggaard Jensen, MD

Role: primary

bjerggaard@clin.au.dk

+45 30915682

Other Identifiers

1-10-72-272-19

Identifier Type: -

Identifier Source: org_study_id