Influence of Hormone Treatment in Radiation Therapy for Bladder Cancer

Quality of Life Clinical Trial

Official title:

Influence of Hormone Treatment in Radiation Therapy for Bladder Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04282876
• Other study ID #: 1-10-72-272-19
• Status: Recruiting
• Start date: February 19, 2020
• Est. completion date: October 31, 2025

Study information

• Verified date: August 2022
• Source: Aarhus University Hospital
• Contact: Jørgen Jensen, Professor
• Phone: 30915525
• Email: bjerggaard[@]skejby.rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2025
• Est. primary completion date: February 1, 2024
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Quality of Life
• Radiation Therapy Complication
• Urinary Bladder Neoplasms

Intervention

Drug:
• Degarelix
Patients receiving Degarelix

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder fibrosis	Fibrosis of the bladder determined by bladder biopsy estimated by number of fibrotic fibers on IHC staining	3 months after radiation