Clinical trial · Interventional
TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer
TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer (TOPCOP3): a Pilot RCT and Process Evaluation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GA+M Intervention | Other | — | UNRESOLVED |
| GA+RSM intervention | Other | — | UNRESOLVED |
| RSM intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- GA+M Intervention
- description
- 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.
- interventionNames
- Other: GA+M Intervention
- type
- ACTIVE_COMPARATOR
- label
- RSM Intervention
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAlibhai 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