Prostate Cancer
Conditions
Keywords
Prostate cancer, Chemotherapy, mCRPC
Brief summary
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
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.
Interventions
None listed
Sponsors
Prostate Cancer Canada
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 65 years of age 2. 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) 3. 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
1. Unable to speak English fluently. 2. Severe neuropsychiatric abnormalities that prevent study participation. 3. Limited life expectancy (\<3 months) as estimated by the primary oncologist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective physical function | Participants will be followed for the duration of treatment up to 2 years | Will be assessed by 3 physical performance measures |
| Number of falls provided by the participant | Participants will be followed for the duration of treatment up to 2 years | Falls |
| Body fat percentage will be measured using a Tanita 300A analyzer | Participants will be followed for the duration of treatment up to 2 years | Body composition analysis |
| Daily function assessed by questionnaires | Participants will be followed for the duration of treatment up to 2 years | Daily function |
| Grade 3+ toxicity using Common Terminology Criteria for Adverse Events (CTC-AE) version 4.0 | Participants will be followed for the duration of treatment up to 2 years | Toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QOL) | 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 |
| The Montreal Cognitive Assessment (MoCA test) and Trail making tests A&B | Participants will be followed for the duration of treatment up to 2 years | Cognition composite |
Countries
Canada
Outcome results
None listed