TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer (NCT05582772)
TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer (TOPCOP3): a Pilot RCT and Process Evaluation
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (4 items).
Location: St. Michael's hospital — Toronto, Ontario
Age range: 65 Years
🧪 Interventions in This Study
- GA+M Intervention (OTHER)
- RSM intervention (OTHER)
- GA+RSM intervention (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- St. Michael's hospital — Toronto, Ontario
- University Health Network - Princess Margaret Cancer Centre — Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (416) 340-5125
Email: shabbir.alibhai@uhn.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: GA+RSM Combination: Participants will receive both strategies as detailed above, with a GA at baseline.
More studies in Metastatic Prostate Cancer
- 177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer — San Francisco, California
- Phase Ia/Ib Talazoparib + Tazemetostat for mCRPC — Boston, Massachusetts
- Physician- and Patient-based Barriers to NGS Testing — Baltimore, Maryland
- A Journey Into Participation Patterns Among Metastatic Prostate Cancer Patients — San Francisco, California
- PSMAtrack-tracking Changes in PSMA-PET During Initial Therapy for Metastatic Hormone-sensitive Prostate Cancer — Boston, Massachusetts
Explore by condition: All Metastatic Prostate Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.