Status:
RECRUITING
Stereotactic Ablative Radiation Therapy for Abiraterone-Resistant, Oligoprogressive Metastatic Prostate Cancer
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Oligoprogressive
Castration-Resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
There is increasing worldwide interest in exploring stereotactic ablative body radiotherapy (SABR) for treating metastases in men with prostate cancer, including for the treatment of oligoprogressive ...
Detailed Description
There is increasing worldwide interest in exploring the use of SABR for metastatic, treatment-naive prostate cancer, eg for delaying the need to start androgen deprivation therapy (ADT), and ultimatel...
Eligibility Criteria
Inclusion
- ECOG performance status 0-1.
- Histologic confirmation of prostate adenocarcinoma.
- Documentation of metastatic, castration-resistant prostate cancer.
- Patient being treated with abiraterone.
- Evidence of oligoprogression (according to RECIST \[V1.1\] and/or Prostate Cancer Working Group criteria \[PCWG3\], as applicable), applying any of the following: (i) ≤ 5 metastatic lesions progressing on conventional imaging (≤ 3 progressing metastases in any one organ system) while all other metastases are controlled or responding; (ii) PSA progression only, but in the setting of oligometastases (≤ 5 metastatic lesions seen on imaging, with ≤ 3 metastases in any one organ system); in this setting, all metastases will be irradiated.
- All metastases of interest amenable to SABR.
Exclusion
- Patients presenting with unequivocal clinical progression, defined as one of the following: (i) cancer pain requiring the initiation of opioid therapy; (ii) immediate need for cytotoxic chemotherapy as per treating physician's discretion; or (iii) deterioration of performance status to grade ≥ 3 according to ECOG.
- Evidence of spinal cord compression.
- Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, and in-situ cancer.
Key Trial Info
Start Date :
July 16 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04838899
Start Date
July 16 2016
End Date
December 31 2026
Last Update
April 12 2024
Active Locations (1)
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1
Odette Cancer Centre
Toronto, Ontario, Canada, M4N3M5