Trial details
TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer
To find out more about this trial and your cancer treatment options, please speak with your doctor.
Trial short name: TOPCOP3
Official title: TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer
Principal Investigator: Dr. Urban Emmenegger
Cancer type: Genitourinary
Cancer location: Genitourinary
Disease stage: Early Cancer
Trial phase: Other
Intervention: Other: GA+M Intervention Other: RSM intervention Other: GA+RSM intervention
Registration #:
NCT05582772 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
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.
Inclusion Criteria: Starting an ARAT for mPC (castration-sensitive or resistant) At least 70 years old Able to provide written informed consent Has a working telephone Exclusion Criteria: Unable to speak English (as contact with the nurse interventionist is via phone, not all outcome measures are available in multiple languages) Major neuropsychiatric abnormalities (severe depression or moderate-severe dementia) Life expectancy <3 months as estimated by the oncologist
