Supportive care for older men with metastatic prostate cancer
Official title: TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer (TOPCOP3): a Pilot RCT and Process Evaluation
Run by University Health Network, Toronto · NCT05582772 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | Men only |
| Enrollment | 168 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Toronto, Ontario and 2 other locations) |
| Status | Recruiting |
| Started | May 23, 2023 |
| Main results expected | February 28, 2027 |
| Study ends | February 28, 2027 |
| Registry record updated | July 3, 2025 |
| Trial ID | NCT05582772 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men aged 65 and older who are starting or have recently started ARATs for metastatic prostate cancer.
✕Probably not a fit
Patients with major neuropsychiatric conditions or a life expectancy of less than three months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promise for supportive care interventions in cancer treatment, suggesting potential for success in this approach.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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JANX013 and JANX007 combo in advanced prostate cancer
A first-in-human study will test JANX013 together with JANX007 to see if this combination is safe and tolerable in adults with metastatic castration-resistant prostate cancer.
-
PSMA PET-Staged Progression-Directed Radiotherapy for Limited Prostate Cancer Progression
A real-world registry tests how well comprehensive progression-directed radiotherapy works for men with metastatic prostate cancer who show a small number of progressing lesions while on systemic therapy.
-
Prostate Radiotherapy and Metastasis-Directed Therapy in Synchronous Oligometastatic Prostate Cancer
This registry follows men with new, limited metastatic prostate cancer who receive targeted radiotherapy to the prostate and all visible metastases to see how they do over time in real-world care.
-
PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer
This phase II trial tests leuprolide acetate alone versus with 177Lu-PSMA-617 (with or without abiraterone acetate and prednisone) in men with hormone-sensitive, low-volume metastatic prostate cancer.
-
First-in-human imaging test of the GRPR-targeted theranostic pair for advanced breast or prostate cancer
This early feasibility study tests a GRPR-targeted imaging agent for PET and a low-dose radiopharmaceutical for SPECT in adults with advanced breast or prostate cancer to see if it is safe and can image tumors.
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Combined treatment approach in metastatic prostate cancer using AZD2265 (FPI-2265) with palacaparib or docetaxel
This study tests how AZD2265 (FPI-2265) with or without palacaparib or docetaxel works in men with metastatic castration-resistant prostate cancer who have already tried AR pathway inhibitors.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.