Investigating a new treatment approach for metastatic prostate cancer
Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate
This study is testing if adding a new drug to regular radiation and hormone therapy can help men with metastatic prostate cancer feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Male |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT05404139 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of adding an androgen receptor pathway inhibitor, abiraterone, to standard radiation and hormone therapy for patients with oligometastatic prostate cancer. Participants are randomly assigned to receive either standard treatment or the combination treatment for 8-9 months, followed by routine follow-ups for up to 5 years. The goal is to determine if this combination improves quality of life compared to standard care alone.
Who should consider this trial
Good fit: Ideal candidates are men over 18 with a recent diagnosis of stage IV castrate-sensitive metastatic prostate cancer and limited metastases.
Not a fit: Patients with significant comorbidities or a history of recent malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance the quality of life for patients with metastatic prostate cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \> 18 years 2. Able to provide informed consent 3. Histologic diagnosis of prostate adenocarcinoma 4. ECOG performance status 0-2 5. Stage IV castrate sensitive metachronous metastatic prostate cancer. diagnosed within 6 months of study enrollment with 1-10 metastases 1. Maximum one metastatic deposit on conventional imaging (CT or bone scan or MR) 2. Additional metastases can be detectable by PSMA PET only 6. All sites of disease are amenable to and can be safely treated with radiotherapy 7. Patients decline continuous use of ADT Exclusion Criteria: 1. Significant comorbidities rendering patient not suitable for ADT, enzalutamide and SBRT 2. History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively 3. Prior use of salvage systemic therapy 4. Evidence of spinal cord compression
Where this trial is running
Toronto, Ontario and 1 other locations
- Princess Margaret Cancer Center — Toronto, Ontario, Canada (Recruiting)
- Sunnybrook Research Institute — Toronto, Ontartio, Canada (Active_not_recruiting)
Study contacts
- Study coordinator: Rachel Glicksman, MD
- Email: rachel.glicksman@uhn.ca
- Phone: 416-946-4961
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.