Recruiting

Supportive Care

Sponsor:

University Health Network, Toronto

Code:

NCT05582772

Conditions

Metastatic Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 65+

Healthy Volunteers: Not accepted

Interventions

GA+M Intervention

RSM intervention

GA+RSM intervention

Study Details

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.

Conditions

Metastatic Prostate Cancer

Study ID

NCT05582772

Start date

May 23, 2023

Status verified date

Jun, 2025

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: GA+M Intervention

GA+M intervention arm All participants in the GA+M intervention arm will undergo a standardized GA by a trained nurse and geriatrician. The GA will include 8 domains (comorbidity, medication review, function, falls risk, nutrition, social supports, cognition, and mood) similar to our 5C protocol.

Based on any detected abnormalities or issues, a standardized set of strategies will be implemented (e.g. increased falls risk will lead to detailed assessment of balance and gait, consideration of gait aid, and referral to outpatient physiotherapy). This follows the standard approach to implementing GA similar to recent trials in geriatric oncology including 5C. Telephone follow-ups at 1, 3 and 6 months by the nurse and review with the geriatrician as needed will be done to ensure identified issues have been addressed.

active comparator: RSM Intervention

RSM Intervention All participants in the RSM intervention arm will receive once-weekly symptom monitoring via email-based surveys using the 9-item Edmonton Symptom Assessment Scale within a secure customized REDCap interface. If patients prefer, weekly telephone calls will be done instead by a research assistant to elicit If there are moderate or severe symptoms (score of 4+ out of 10), an oncology nurse will obtain more detailed symptom information and provide evidence-based symptom-targeted recommendations using the pan-Canadian Oncology Symptom Triage and Remote Support (COSTaRS) Practice Guide. Symptom monitoring will continue for 6 months or discontinuation of treatment.

active comparator: GA+RSM intervention

GA+RSM Combination Participants will receive both strategies as detailed above, with a GA at baseline.

no intervention: Control

Control Usual care consists of brief verbal education and a drug pamphlet to all patients when starting an ARAT. There is no GA+M and no RSM at either site. Patients have access to a 24x7 oncology nursing line or a 24/7 pharmacy line.

Interventions

GA+M Intervention

Typically 8 domains (cognition, comorbidities, falls risk, functional status, medication use, mood - depression, nutritional status, social support) are examined by a team consisting of a nurse and geriatrician. A GA has multiple benefits and has been recommended for all older adults considering chemotherapy by the American Society of Clinical Oncology (ASCO). For a GA to be most useful it needs to be followed by co-management of identified issues.

RSM intervention

Telephone-based, symptom management of patients with cancer

GA+RSM intervention

Combining a geriatric assessment and remote symptom control

Primary outcome measure

  • Number of participants with Grade 3-5 Toxicity [ Time Frame: 6 months ]
  • Health related quality of life in patients with metastatic prostate cancer [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Shabbir Alibhai, MD

(416) 340-5125shabbir.alibhai@uhn.ca

Soha Abdallah, PhD

416-946-4501soha.abdallah@uhn.ca

Locations

St. Michael's hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Ronita Lee, MD

416-864-5912Ronita.Lee@unityhealth.to

University Health Network - Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2C1

Contacts

Shabbir Alibhai, MD

4163405125shabbir.alibhai@uhn.ca

Soha Abdallah

416-946-4501soha.abdallah@uhn.ca

Principal Investigator:

Shabbir Alibhai, MD

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada

Contacts

Urban Emmenegger, MD

416-480-4928urban.emmenegger@sunnybrook.ca

Principal Investigator:

Urban Emmenegger, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jul 3, 2025

Last verified

Jun, 2025

Keywords

  • Geriatric assessment
  • ARAT
  • Supportive Care
  • Older men

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-07-03.