TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer

NCT05582772 | Recruiting

• 1 other identifier: 4090
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 3

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

Keywords

Geriatric assessment; ARAT; Supportive Care; Older men

Outcome Measures

Primary Outcomes (2)

• Number of participants with Grade 3-5 Toxicity

  Grade 3-5 toxicity. This will be coded as at least one grade 3-5 toxicity vs none, measured based on review of clinical notes supplemented by interviews with patients by trained research staff and verified by a blinded physician. Toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  6 months

• Health related quality of life in patients with metastatic prostate cancer

  QOL will be measured by patient self-report using the EQ-5D-5L, which is the EuroQol 5 dimensions of health questionnaire. This is a widely used, psychometrically valid brief generic QOL questionnaire.

  6 months

Secondary Outcomes (9)

• Number of patients with treatment discontinuation

  6 months

• Number of patients with treatment modification

  6 months

• Number of patients with severe symptoms

  6 months

• Number of patients with decline in Instrumental Activities of Daily Living (IADL)

  6 months

• Number of patients with unplanned health care

  6 months

Other Outcomes (2)

• Process evaluation: Feasibility

  6 months

• Process evaluation: Acceptability

  6 months

Study Arms (4)

GA+M Intervention

ACTIVE COMPARATOR

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.

Other: GA+M Intervention

RSM Intervention

ACTIVE COMPARATOR

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.

Other: RSM intervention

GA+RSM intervention

ACTIVE COMPARATOR

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

Other: GA+RSM intervention

Control

NO INTERVENTION

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 OTHER

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.

Also known as: Geriatric assessment and management

GA+M Intervention

RSM intervention OTHER

Telephone-based, symptom management of patients with cancer

Also known as: Remote symptom monitoring

RSM Intervention

GA+RSM intervention OTHER

Combining a geriatric assessment and remote symptom control

Also known as: Geriatric assessment and remote symptom monitoring

GA+RSM intervention

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: This RCT is in metastatic prostate cancer, which occurs in men only.
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Starting an ARAT or started an ARAT within 2 weeks prior to being approached or switching ARATs due to progression or toxicity
• Diagnosed with mPC (castration-sensitive or resistant) or nmCRPC (non-metastatic castration-resistant prostate cancer)
• At least 65 years old
• Able to provide written informed consent
• Has a working telephone

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Rising Tide Foundation: collaborator

Study Sites (3)

St. Michael's hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

RECRUITING

Related Publications (1)

• Alibhai SMH, Puts M, Jin R, Godhwani K, Antonio M, Abdallah S, Feng G, Krzyzanowska MK, Soto-Perez-de-Celis E, Papadopoulos E, Mach C, Nasiri F, Sridhar SS, Glicksman R, Moody L, Bender J, Clarke H, Matthew A, McIntosh D, Klass W, Emmenegger U. TOward a comPrehensive supportive Care intervention for Older men with metastatic Prostate cancer (TOPCOP3): A pilot randomized controlled trial and process evaluation. J Geriatr Oncol. 2024 Jul;15(6):101750. doi: 10.1016/j.jgo.2024.101750. Epub 2024 Mar 23.

  PMID: 38521641 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Geriatric Assessment; Therapeutics

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Shabbir Alibhai, MD

  UHN - Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shabbir Alibhai, MD

CONTACT

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

Soha Abdallah, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given the nature of the intervention, it is not possible to blind patients or the project team to allocation, however, the statistician is blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This model will provide within-group change scores for both co-primary outcomes (i.e., grade 3-5 toxicity and QOL) along with standard deviations and responsiveness measure. These data will guide selection of the single or dual primary outcome for the definitive phase III RCT as well as inform sample size calculations. Importantly, they will not be used to determine the clinically important difference used to plan for the phase III RCT. These 2 co-primary outcomes were selected based on literature review, clinical input, and patient-partner input.

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: October 17, 2022
• Study Start: May 23, 2023
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)