NCT05582772Recruiting
TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer
TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer (TOPCOP3): a Pilot RCT and Process Evaluation
Source: ClinicalTrials.gov · Last updated 3 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 168 (estimated)
- First submitted
- 16 Sept 2022
- Start date
- 23 May 2023
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Prostate cancer
- NCT number
- NCT05582772
What you commit to
- Study type: Interventional
- Planned participants: 168
- From 23 May 2023 to the primary completion date, 28 Feb 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Major neuropsychiatric abnormalities (severe depression or moderate-severe dementia)
Other
- Unable to speak English (as contact with the nurse interventionist is via phone, not all outcome measures are available in multiple languages)
- Life expectancy \<3 months as estimated by the oncologist
Who the study is looking for
- Starting an ARAT or started an ARAT within 2 weeks prior to being approached or switching ARATs due to progression or toxicity
- Diagnosed with mPC (castration-sensitive or resistant) or nmCRPC (non-metastatic castration-resistant prostate cancer)
- At least 65 years old
- Able to provide written informed consent
- Has a working telephone
Age in the registry: 65 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network - Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.