Clinical trial Recruiting at 3 sites Interventional Ages 65 and up Men only

Supportive care for older men with metastatic prostate cancer

Official title: TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer (TOPCOP3): a Pilot RCT and Process Evaluation

Run by University Health Network, Toronto · NCT05582772 · Data updated 2026-11-12

This study is testing whether a special care plan and remote symptom tracking can help older men with advanced prostate cancer feel better when starting or changing their hormone treatments.

Quick facts

Study typeInterventional
Ages65 Years and up
SexMen only
Enrollment168 (estimated)
SponsorUniversity Health Network, Toronto
Academic / other
Drugs / interventionschemotherapy
Locations3 sites (Toronto, Ontario and 2 other locations)
StatusRecruiting
StartedMay 23, 2023
Main results expectedFebruary 28, 2027
Study endsFebruary 28, 2027
Registry record updatedJuly 3, 2025
Trial IDNCT05582772 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men aged 65 and older who are starting or have recently started ARATs for metastatic prostate cancer.

Probably not a fit

Patients with major neuropsychiatric conditions or a life expectancy of less than three months may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial evaluates the effectiveness of geriatric assessment and management (GA+M) and remote symptom monitoring (RSM) in older men with metastatic prostate cancer who are starting or switching androgen receptor-targeted therapies (ARATs). The study aims to determine the feasibility of these interventions and gather data on their potential impact on treatment tolerability and quality of life. By comparing these interventions to usual care, the trial seeks to inform the design of a larger definitive phase III trial. The study is designed in collaboration with patients to ensure relevance and applicability of findings.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the quality of life and treatment outcomes for older men with metastatic prostate cancer.

How similar studies have gone: Previous studies have shown promise for supportive care interventions in cancer treatment, suggesting potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Starting an ARAT or started an ARAT within 2 weeks prior to being approached or switching ARATs due to progression or toxicity
2. Diagnosed with mPC (castration-sensitive or resistant) or nmCRPC (non-metastatic castration-resistant prostate cancer)
3. At least 65 years old
4. Able to provide written informed consent
5. Has a working telephone

Exclusion Criteria:

1. Unable to speak English (as contact with the nurse interventionist is via phone, not all outcome measures are available in multiple languages)
2. Major neuropsychiatric abnormalities (severe depression or moderate-severe dementia)
3. Life expectancy \<3 months as estimated by the oncologist

Where it's running

  • St. Michael's hospital
    Toronto, Ontario, Canada
    Recruiting
  • University Health Network - Princess Margaret Cancer Centre
    Toronto, Ontario, Canada
    Recruiting
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.