Influence of Hormone Treatment in Radiation Therapy for Bladder Cancer

NCT04282876 | Unknown

• 1 other identifier: 1-10-72-272-19
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Radiation Therapy Complication; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Bladder fibrosis

  Fibrosis of the bladder determined by bladder biopsy estimated by number of fibrotic fibers on IHC staining

  3 months after radiation

Study Arms (2)

Degarelix

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

Drug: Degarelix

Control

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

Interventions

Degarelix DRUG

Patients receiving Degarelix

Degarelix

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Males with invasive bladder cancer, treated with radiation therapy.

You may qualify if:

• T2-T4 bladder cancer
• radiation therapy
• able to fill out questionnaires
• signed informed consent

You may not qualify if:

• KAD prior to TUR-B
• dementia or other cognitive impairment
• metastatic disease

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bladder biopsies

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Jørgen Jensen, Professor

CONTACT

30915525; bjerggaard@skejby.rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 25, 2020
• Study Start: February 19, 2020
• Primary Completion: February 1, 2024
• Study Completion: October 31, 2025
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)