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Influence of Hormone Treatment in Radiation Therapy for Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04282876
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : August 8, 2022
Sponsor:
Information provided by (Responsible Party):
Jørgen Bjerggaard Jensen, Aarhus University Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Bladder Cancer Radiation Therapy Complication Quality of Life Drug: Degarelix

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Degarelix

Groups and Cohorts
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Group/Cohort Intervention/treatment
Degarelix
Patients undergoing radiation therapy for bladder cancer while also being treated with Degarelix (androgen deprivation therapy)
 Drug: Degarelix
Patients receiving Degarelix
Control
Patients undergoing radiation therapy for bladder cancer with or without simultanous treatment with androgen deprivation therapy (not Degarelix)


Outcome Measures
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Primary Outcome Measures :
  1. 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
Bladder biopsies

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Sampling Method:   Probability Sample
Study Population
Males with invasive bladder cancer, treated with radiation therapy.
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jørgen Jensen, Professor 30915525 bjerggaard@skejby.rm.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Jørgen Bjerggaard Jensen, MD    +45 30915682    bjerggaard@clin.au.dk   
Sponsors and Collaborators
Aarhus University Hospital
More Information
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Responsible Party: Jørgen Bjerggaard Jensen, Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT04282876    
Other Study ID Numbers: 1-10-72-272-19
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: August 8, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urologic Diseases
Male Urogenital Diseases