TOward a comPrehensive supportive Care intervention for Older men with metastatic Prostate cancer (TOPCOP3): A pilot randomized controlled trial and process evaluation.

Current management of metastatic prostate cancer (mPC) includes androgen receptor axis-targeted therapy (ARATs), which is associated with substantial toxicity in older adults. Geriatric assessment and management and remote symptom monitoring have been shown to reduce toxicity and improve quality of life in patients undergoing chemotherapy, but their efficacy in patients being treated with ARATs has not been explored.

The purpose of this study is to examine whether these interventions, alone or in combination, can improve treatment tolerability and quality of life (QOL) for older adults with metastatic prostate cancer on ARATs.

TOPCOP3 is a multi-centre, factorial pilot clinical trial coupled with an embedded process evaluation. The study includes four treatment arms: geriatric assessment and management (GA + M); remote symptom monitoring (RSM); geriatric assessment and management plus remote symptom monitoring; and usual care and will be followed for six months. The aim is to recruit 168 patients between two cancer centres in Toronto, Canada. Eligible participants will be randomized equally via REDCap. Participants in all arms will complete a comprehensive baseline assessment upon enrollment following the Geriatric Core dataset, as well as follow-up assessments at 1.5, 3, 4.5, and 6 months. The co-primary outcomes will be grade 3-5 toxicity and QOL. Toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. QOL will be measured by patient self-reporting using the EuroQol 5 dimensions of health questionnaire. Secondary outcomes include fatigue, insomnia, and depression. Finally, four process evaluation outcomes will also be observed, namely feasibility, fidelity, and acceptability, along with implementation barriers and facilitators.

Data will be collected to observe the effects of GA + M and RSM on QOL and toxicities experienced by older adults receiving ARATs for metastatic prostate cancer. Data will also be collected to help the design and conduct of a definitive multicentre phase III randomized controlled trial. This study will extend supportive care interventions for older adults with cancer into new areas and inform the design of larger trials.

The trial is registered at (registration number: NCT05582772).

Journal of geriatric oncology. 2024 Mar 22 [Epub ahead of print]

Shabbir M H Alibhai, Martine Puts, Rana Jin, Kian Godhwani, Maryjo Antonio, Soha Abdallah, Gregory Feng, Monika K Krzyzanowska, Enrique Soto-Perez-de-Celis, Efthymios Papadopoulos, Calvin Mach, Ferozah Nasiri, Srikala S Sridhar, Rachel Glicksman, Lesley Moody, Jacqueline Bender, Hance Clarke, Andrew Matthew, Dennis McIntosh, Winston Klass, Urban Emmenegger

Department of Medicine, University Health Network, Toronto, Ontario, Canada. Electronic address: ., Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada., Department of Medicine, University Health Network, Toronto, Ontario, Canada., Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada., Department of Geriatrics, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico., School of Kinesiology, Louisiana State University, Baton Rouge, LA, USA., Department of Anesthesia and Pain Management, Toronto General Hospital, Toronto, Ontario, Canada., Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network; Department of Radiation Oncology, University of Toronto, Canada., Varian Medical Systems, Winnipeg, Manitoba, Canada., Department of Supportive Care, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada., Department of Surgical Oncology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada., Patient Partner, Toronto, Ontario, Canada., Division of Medical Oncology & Hematology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.

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