Towards Optimal Prescription of Chemotherapy in Prostate Cancer

NCT02512185 | Completed

• 1 other identifier: 15-9075
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 4

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Chemotherapy; mCRPC

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Quality of Life (QOL)

  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

  Participants will be followed for the duration of treatment up to 2 years

Study Arms (3)

Chemotherapy

Men starting first-line chemotherapy for mCRPC (typically Docetaxel and Prednisone)

Abiraterone

Men with mCRPC starting Abiraterone

Enzalutamide

Men with mCRPC starting Enzalutamide

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Unable to speak English fluently.
• Severe neuropsychiatric abnormalities that prevent study participation.
• Limited life expectancy (\<3 months) as estimated by the primary oncologist.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Prostate Cancer Canada: collaborator

Study Sites (4)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Health Sciences Centre -KGH

Kingston, Ontario, K7L 2V7, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 30, 2015
• Study Start: July 1, 2015
• Primary Completion: April 30, 2019
• Study Completion: December 31, 2019
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)