Towards Optimal Prescription of Chemotherapy in Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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TOward Personalizing Care for Older Men With mCRPC - Understanding and Predicting Treatment Toxicities (the TOPCOP Study)

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 65 years of age Diagnosed with prostate cancer with evidence of clinical and/or radiographic evidence of progression despite adequate androgen deprivation therapy and achievement of castration (total testosterone level <1.7 nmol/L measured within 6 months of enrollment) Among men starting either abiraterone or enzalutamide, no prior chemotherapy/abiraterone/enzalutamide. Among men starting first-line chemotherapy, commencing docetaxel but can have had either prior abiraterone or enzalutamide Exclusion Criteria: Unable to speak English fluently. Severe neuropsychiatric abnormalities that prevent study participation. Limited life expectancy (<3 months) as estimated by the primary oncologist.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chemotherapy<br>Men starting first-line chemotherapy for mCRPC (typically Docetaxel and Prednisone) | |
| Abiraterone<br>Men with mCRPC starting Abiraterone | |
| Enzalutamide<br>Men with mCRPC starting Enzalutamide | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily function assessed by questionnaires | Daily function | Participants will be followed for the duration of treatment up to 2 years | 
| Objective physical function | Will be assessed by 3 physical performance measures | Participants will be followed for the duration of treatment up to 2 years | 
| Grade 3+ toxicity using Common Terminology Criteria for Adverse Events (CTC-AE) version 4.0 | Toxicity | Participants will be followed for the duration of treatment up to 2 years | 
| Number of falls provided by the participant | Falls | Participants will be followed for the duration of treatment up to 2 years | 
| Body fat percentage will be measured using a Tanita 300A analyzer | Body composition analysis | Participants will be followed for the duration of treatment up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QOL) | FACT-G and FACT-P (specific for prostate cancer) questionnaires will be administered | Participants will be followed for the duration of treatment up to 2 years | 
| The Montreal Cognitive Assessment (MoCA test) and Trail making tests A&B | Cognition composite | Participants will be followed for the duration of treatment up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Chemotherapy, mCRPC