Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)
NCT03269422
Genital Diseases, Genital Diseases, Male
Basking Ridge, New Jersey, United States
View Trial DetailsNCT Number: NCT02512185
This study will examine the impact of modern treatments for metastatic Castrate Resistant Prostate Cancer (mCRPC) on several relevant 'geriatric' domains such as daily function, objective physical function, and falls. Additionally, the investigators study whether frailty is associated with worse outcomes, and whether it is possible to predict the risk of severe chemotherapy toxicity in older men.
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Notify Me65 year and older
Male
Observational
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Our primary aims are (a) to examine the impact of pre-treatment frailty on 'elder-relevant' outcomes including daily function, objective physical function, falls, quality of life (QOL), and early treatment discontinuation; (b) to determine whether the Hurria/Cancer and Aging Research Group (CARG) tool is able to predict severe (grade 3+) chemotherapy toxicity in men starting chemotherapy. Our secondary aim is to understand the impact of abiraterone and enzalutamide on 'elder-relevant' outcomes.
This is a prospective multicentre observational study. The investigators will enroll men age 65 or older with mCRPC who are starting (a) first-line chemotherapy; (b) abiraterone; or (c) enzalutamide. Assessments will occur prior to starting treatment and every 2 months thereafter until the end of treatment.
As treatment options become more complex in older men with mCRPC, understanding and predicting a wide range of treatment toxicities is important and will aid decision-making and management.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Participants will be followed for the duration of treatment up to 2 years
Daily function
Time frame: Participants will be followed for the duration of treatment up to 2 years
Will be assessed by 3 physical performance measures
Time frame: Participants will be followed for the duration of treatment up to 2 years
Toxicity
Time frame: Participants will be followed for the duration of treatment up to 2 years
Falls
Time frame: Participants will be followed for the duration of treatment up to 2 years
Body composition analysis
Time frame: Participants will be followed for the duration of treatment up to 2 years
FACT-G and FACT-P (specific for prostate cancer) questionnaires will be administered
Time frame: Participants will be followed for the duration of treatment up to 2 years
Cognition composite
University Health Network, Toronto
Other
TOward Personalizing Care for Older Men With mCRPC - Understanding and Predicting Treatment Toxicities (the TOPCOP Study)
Acronym: TOPCOP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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