Actively Recruiting
Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)
Led by University Health Network, Toronto · Updated on 2024-11-25
132
Participants Needed
2
Research Sites
144 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
A
Astellas Pharma Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-centre, investigator-initiated, two-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor to standard of care radiation and hormone therapy improve quality of life. Participants will either receive standard of care radiation and hormone (ADT) therapy (Arm 1) or standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months (Arm 3). Participants will be routinely follow-up in clinic or remotely for up to 5 years.
CONDITIONS
Official Title
Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Able to provide informed consent
- Histologic diagnosis of prostate adenocarcinoma
- ECOG performance status 0-2
- Stage IV castrate sensitive metachronous metastatic prostate cancer diagnosed within 6 months with 1-10 metastases
- Maximum one metastatic deposit visible on conventional imaging (CT, bone scan, or MRI)
- Additional metastases may be detectable only by PSMA PET
- All sites of disease can be safely treated with radiotherapy
- Patients who decline continuous use of ADT
You will not qualify if you...
- Significant health problems making ADT, enzalutamide, or SBRT unsuitable
- History of other malignancy within the past 5 years except non-melanoma skin cancer and non-curative in-situ cancer
- Prior use of salvage systemic therapy
- Evidence of spinal cord compression
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
2
Sunnybrook Research Institute
Toronto, Ontartio, Canada, M4N 3M5
Active, Not Recruiting
Research Team
R
Rachel Glicksman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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