Status:
RECRUITING
Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Metastatic Prostate Cancer
Eligibility:
MALE
18-100 years
Phase:
PHASE2
Brief Summary
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 q...
Eligibility Criteria
Inclusion
- Age \> 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 of study enrollment with 1-10 metastases
- Maximum one metastatic deposit on conventional imaging (CT or bone scan or MR)
- Additional metastases can be detectable by PSMA PET only
- All sites of disease are amenable to and can be safely treated with radiotherapy
- Patients decline continuous use of ADT
Exclusion
- Significant comorbidities rendering patient not suitable for ADT, enzalutamide and SBRT
- History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively
- Prior use of salvage systemic therapy
- Evidence of spinal cord compression
Key Trial Info
Start Date :
May 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT05404139
Start Date
May 24 2023
End Date
March 1 2026
Last Update
November 25 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2M9
2
Sunnybrook Research Institute
Toronto, Ontartio, Canada, M4N 3M5