NCT05582772 TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer
| NCT ID | NCT05582772 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Metastatic Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2023-05-23 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 168 participants in total. It began in 2023-05-23 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Shabbir Alibhai, MD
PRINCIPAL INVESTIGATOR
UHN - Princess Margaret Cancer Centre
Frequently Asked Questions
Who can join the NCT05582772 clinical trial?
This trial is open to male participants only, aged 65 Years or older, studying Metastatic Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05582772 currently recruiting?
Yes, NCT05582772 is actively recruiting participants. Contact the research team at shabbir.alibhai@uhn.ca for enrollment information.
Where is the NCT05582772 trial being conducted?
This trial is being conducted at Toronto, Canada, Toronto, Canada, Toronto, Canada.
Who is sponsoring the NCT05582772 clinical trial?
NCT05582772 is sponsored by University Health Network, Toronto. The principal investigator is Shabbir Alibhai, MD at UHN - Princess Margaret Cancer Centre. The trial plans to enroll 168 participants.
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