Towards Optimal Prescription of Chemotherapy in Prostate Cancer

Prostate Cancer Clinical Trial

— TOPCOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512185
• Other study ID #: 15-9075
• Status: Completed
• Start date: July 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: December 31, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Kingston Health Sciences Centre -KGH	Kingston	Ontario
Canada	Odette Cancer Centre	Toronto	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Prostate Cancer Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily function assessed by questionnaires	Daily function	Participants will be followed for the duration of treatment up to 2 years
Primary	Objective physical function	Will be assessed by 3 physical performance measures	Participants will be followed for the duration of treatment up to 2 years
Primary	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
Primary	Number of falls provided by the participant	Falls	Participants will be followed for the duration of treatment up to 2 years
Primary	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	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
Secondary	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