Actively Recruiting

Phase Not Applicable
Age: 65Years +
MALE
NCT05582772

TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer

Led by University Health Network, Toronto · Updated on 2025-07-03

168

Participants Needed

3

Research Sites

196 weeks

Total Duration

On this page

Sponsors

U

University Health Network, Toronto

Lead Sponsor

R

Rising Tide Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

TOPCOP3 is a pilot factorial RCT of geriatric assessment and management, remote symptom monitoring, both interventions or neither, accompanied by an embedded process evaluation. This design is widely used to guide the evaluation of complex interventions and provides important data to aid design of larger RCTs. The trial itself falls within pilot trial goals including obtaining variance estimates for outcomes, assessment of recruitment potential, and understanding implementation issues vital to designing a larger trial. The investigators have clear feasibility objectives and an analytic plan as well as criteria to determine success and strong support from cancer advocacy and policy groups.

CONDITIONS

Official Title

TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer

Who Can Participate

Age: 65Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Starting an androgen receptor axis-targeted therapy (ARAT) or started ARAT within 2 weeks prior to being approached or switching ARATs due to progression or toxicity
  • Diagnosed with metastatic prostate cancer (castration-sensitive or resistant) or non-metastatic castration-resistant prostate cancer
  • At least 65 years old
  • Able to provide written informed consent
  • Has a working telephone
Not Eligible

You will not qualify if you...

  • Unable to speak English
  • Major neuropsychiatric abnormalities such as severe depression or moderate-severe dementia
  • Life expectancy less than 3 months as estimated by the oncologist

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

St. Michael's hospital

Toronto, Ontario, Canada, M5B 1W8

Actively Recruiting

2

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2C1

Actively Recruiting

3

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Actively Recruiting

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Research Team

S

Shabbir Alibhai, MD

CONTACT

S

Soha Abdallah, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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