Actively Recruiting
Stereotactic Ablative Radiotherapy for Oligoprogressive Metastatic Castration-Resistant Prostate Cancer During Abiraterone Therapy
Led by Sunnybrook Health Sciences Centre · Updated on 2024-04-12
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating stereotactic ablative body radiotherapy (SABR) as a treatment for men with metastatic castration-resistant prostate cancer (mCRPC) who have oligoprogressive disease while on abiraterone therapy. Oligoprogression means a few metastatic tumors worsen while others remain stable or respond to treatment. This study aims to see if SABR can delay the need to switch systemic therapy and improve progression-free survival in this setting. The trial also focuses on measuring the safety of SABR in this group of patients. Participants will receive SABR directed at all progressive metastatic sites identified on conventional imaging. Standard SABR doses are used depending on the location of metastases, such as 35 Gy in 5 fractions for the prostate, 30-40 Gy in 5 fractions for non-spine bone metastases, and appropriate doses for spine, lymph nodes, brain, lung, liver, and adrenal metastases. Patients will continue taking abiraterone during and after the SABR treatments. Throughout the study, participants will be monitored for SABR-related toxicities up to 12 months and progression-free survival over 24 months. Additional assessments include biochemical progression, time to change of systemic therapy, radiographic control of treated areas, distant progression-free survival, overall survival up to 36 months, and quality of life evaluations. The study is sponsored by Sunnybrook Health Sciences Centre and involves ongoing follow-up to understand SABR's effects in this patient group.
CONDITIONS
Brief Title
Stereotactic Ablative Radiation Therapy for Abiraterone-Resistant, Oligoprogressive Metastatic Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status 0-1
- Histologic confirmation of prostate adenocarcinoma
- Documented metastatic, castration-resistant prostate cancer
- Currently treated with abiraterone
- Evidence of oligoprogression with 5 or fewer metastatic lesions progressing on imaging, with no more than 3 progressing in any one organ system, or PSA progression with up to 5 metastases seen on imaging
- All metastases must be suitable for SABR treatment
You will not qualify if you...
- Clinical progression defined by cancer pain requiring opioids, immediate need for chemotherapy, or ECOG performance status 3 or higher
- Evidence of spinal cord compression
- Prior malignancy within the past 5 years, except non-melanoma skin cancer or in-situ cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 fractions over 1 to 2 weeks
Participants receive stereotactic ablative radiation therapy (SABR) targeting all progressive metastatic sites while continuing abiraterone therapy.
1 to 5 visits (in-person) depending on SABR dose fractionation
Duration - Up to 24 months
Participants are monitored for SABR-related toxicities and progression-free survival while continuing abiraterone.
Regular visits during follow-up period as per study schedule
Trial Site Locations
Total: 1 location
1
Odette Cancer Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
Research Team
U
Urban Emmenegger, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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