Supportive care 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
NA · University Health Network, Toronto · NCT05582772
This study is testing whether a special care plan and remote symptom tracking can help older men with advanced prostate cancer feel better when starting or changing their hormone treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 65 Years and up |
| Sex | Male |
| Sponsor | University Health Network, Toronto (other) |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Toronto, Ontario and 2 other locations) |
| Trial ID | NCT05582772 on ClinicalTrials.gov |
What this trial studies
This pilot trial evaluates the effectiveness of geriatric assessment and management (GA+M) and remote symptom monitoring (RSM) in older men with metastatic prostate cancer who are starting or switching androgen receptor-targeted therapies (ARATs). The study aims to determine the feasibility of these interventions and gather data on their potential impact on treatment tolerability and quality of life. By comparing these interventions to usual care, the trial seeks to inform the design of a larger definitive phase III trial. The study is designed in collaboration with patients to ensure relevance and applicability of findings.
Who should consider this trial
Good fit: Ideal candidates are men aged 65 and older who are starting or have recently started ARATs for metastatic prostate cancer.
Not a fit: Patients with major neuropsychiatric conditions or a life expectancy of less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and treatment outcomes for older men with metastatic prostate cancer.
How similar studies have performed: Previous studies have shown promise for supportive care interventions in cancer treatment, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario and 2 other locations
- St. Michael's hospital — Toronto, Ontario, Canada (RECRUITING)
- University Health Network - Princess Margaret Cancer Centre — Toronto, Ontario, Canada (RECRUITING)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Shabbir Alibhai, MD — UHN - Princess Margaret Cancer Centre
- Study coordinator: Shabbir Alibhai, MD
- Email: shabbir.alibhai@uhn.ca
- Phone: (416) 340-5125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastatic Prostate Cancer, Geriatric assessment, ARAT, Supportive Care, Older men