Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00017727

Trial Description

start of 1:1-Block title

Title

Neurocognitive effects in patients with advanced prostate cancer treated with androgen deprivation therapy

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

NEPPA

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Prostate cancer is the second most prevalent type of cancer among men. Whereas there are several therapeutic interventions to treat advanced prostate cancer, hormone therapy to prevent endogenous androgen production is one of them. Positive effects in treating advanced prostate cancer and some of the hormone therapy’s side effects are already thoroughly investigated. Besides that, negative effects on neurocognitive functioning (e.g., memory performance) are currently discussed controversially. Similar effects are studied regarding other medication to treat advanced prostate cancer, in particular regarding cytostatic agents (chemotherapeutics). The main purpose of the study is to evaluate, if there is a higher percentage of neurocognitive deficits in men undergoing hormone therapy, compared to the representative norm. Here, the participants’ age and education is considered and controlled for. Moreover, associations with the patients’ course of disease and treatment are studied. Simultaneously, other psychological and psychosocial factors such as the patient’s quality of life are investigated and included in the analyses. Results are meant to contribute to improved patient counselling and care. Therefor, it is planned to recruit 60 patients suffering from advanced prostate cancer and treated with hormone therapy. The voluntarily participating patients are recruited at the National Center for Tumor Diseases (NCT) either after the urooncologic doctor’s consultation or after having received treatment. The neurocognitive assessment will include validated tests to evaluate cognitive domains that are assumed to be particularly vulnerable when being diagnosed with prostate cancer. Moreover, the participants are asked to complete a validated survey asking for anamnestic data and the patient’s subjective perception regarding psychological, psychosocial and neurocognitive functioning.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Prostate cancer is the second most prevalent type of cancer among men. Androgen deprivation therapy (ADT) to prevent endogenous androgen production is the first line medication to treat advanced prostate cancer in Germany. Its positive effects in treating advanced prostate cancer and some of the hormone therapy’s side effects are already thoroughly investigated. Besides that, negative effects on neurocognitive functioning (e.g., memory performance) are currently discussed controversially. Similar effects are studied regarding other medication to treat advanced prostate cancer, in particular regarding cytostatic agents. The main purpose of the study is to evaluate, if there is a higher percentage of neurocognitive deficits in men undergoing hormone therapy, compared to the representative norm. Here, the participants’ age and education is considered and controlled for. Moreover, associations with the patients’ course of disease and treatment are studied. Simultaneously, other psychological and psychosocial factors such as the patient’s quality of life are investigated and included in the analyses. Results are meant to contribute to improved patient counselling and care. Therefor, it is planned to recruit 60 patients suffering from advanced prostate cancer and treated with hormone therapy. The voluntarily participating patients are recruited at the National Center for Tumor Diseases (NCT) either after the urooncologic doctor’s consultation or after having received treatment. The neurocognitive assessment will include validated tests to evaluate cognitive domains that are assumed to be particularly vulnerable when being diagnosed with prostate cancer. Moreover, the participants are asked to complete a validated survey asking for anamnestic data and the patient’s subjective perception regarding psychological, psychosocial and neurocognitive functioning.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00017727
  •   2019/08/05
  •   [---]*
  •   yes
  •   Approved
  •   S-178/2019, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with advanced prostate cancer will be assessed regarding their subjective perception of various psychological, psychosocial and cognitive domains. Moreover, the patients' cognitive functioning is assessed using a specifically designed test batterie.
  •   Data from a representative German-speaking norm population
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical, Other
  •   Supportive care
  •   Other
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Cognitive Functioning

The neurocognitive assessment includes four tests of the Wiener Testsystem (WTS), Schuhfried GmbH:
- Wiener Wortflüssigkeitstest to measure lexical word fluency
- Auditiver Wortlisten Lerntest to measure some aspects of the patients' memory and learning ability
- Trail Making Test - Langensteinbacher Version to measure some aspects of executive functions
- N-back verbal, another instrument to measure some aspects of executive functions

Moreover, the subjective perception will be assessed using a questionnaire (Funcional Assessment of Cancer Therapy - Cognitive Function; FACT-Cog)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Mental Health, measured with the Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P; questionnaire)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/05/13
  •   60
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   45   Years
  •   85   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Patients with advanced prostate cancer
- Age: 45 - 85 years old
- visiting the urooncological doctor's consultation at the National Center for Tumor Diseases Heidelberg and/or being treated on site
- capacity to consent
- signed informed consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Insufficiant knowledge of the German language
- Neurological and/or psychiatric disorder
- Incorrectable visual impairment

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universität Heidelberg, Psychoonkologische Ambulanz im NCT
    • Mr.  Dr.  Imad  Maatouk 
    • Im Neuenheimer Feld 460
    • D-69120  Heidelberg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universität Heidelberg, Psychoonkologische Ambulanz im NCT
    • Mr.  Dr.  Imad  Maatouk 
    • Im Neuenheimer Feld 460
    • D-69120  Heidelberg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.