Towards Optimal Prescription of Chemotherapy in Prostate Cancer (TOPCOP)

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston Health Sciences Centre -KGH
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Odette Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Men 65 and older starting first line chemotherapy, or Abiraterone, or Enzalutamide for mCRPC

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Chemotherapy; Men starting first-line chemotherapy for mCRPC (typically Docetaxel and Prednisone)
Abiraterone; Men with mCRPC starting Abiraterone
Enzalutamide; Men with mCRPC starting Enzalutamide

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Prostate Cancer Canada

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: July 17, 2015
• First Submitted That Met QC Criteria: July 29, 2015
• First Posted (Estimate): July 30, 2015

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Prostate cancer; Chemotherapy; mCRPC
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 15-9075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO