Clinical trial NCT02512185: Towards Optimal Prescription of Chemotherapy in Prostate Cancer
Official title: TOward Personalizing Care for Older Men With mCRPC - Understanding and Predicting Treatment Toxicities (the TOPCOP Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate cancer
Chemotherapy
mCRPC
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Prostate Cancer Canada
First posted: 2015-07-30
Enrollment: 206
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men 65 and older starting first line chemotherapy, or Abiraterone, or Enzalutamide for 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Daily function assessed by questionnaires
timeFrame: Participants will be followed for the duration of treatment up to 2 years
measure: Objective physical function
timeFrame: Participants will be followed for the duration of treatment up to 2 years
measure: Grade 3+ toxicity using Common Terminology Criteria for Adverse Events (CTC-AE) version 4.0
timeFrame: Participants will be followed for the duration of treatment up to 2 years
measure: Number of falls provided by the participant
timeFrame: Participants will be followed for the duration of treatment up to 2 years
measure: Body fat percentage will be measured using a Tanita 300A analyzer
timeFrame: Participants will be followed for the duration of treatment up to 2 years
Secondary outcomes:
measure: Quality of Life (QOL)
timeFrame: Participants will be followed for the duration of treatment up to 2 years
measure: The Montreal Cognitive Assessment (MoCA test) and Trail making tests A&B
timeFrame: Participants will be followed for the duration of treatment up to 2 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre -KGH
state: Ontario
city: Toronto
country: Canada
facility: Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References: