OligoprogressiveCastration-Resistant Prostate Cancer
Investigational drug(s) / intervention(s)
Stereotactic Body Radiation Therapy (SABR)
Stereotactic Body Radiation Therapy (SABR): SABR to oligoprogressive metastases while continuing abiraterone therapy
Study 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 metastases. The latter applies to a situation whereby patients with widespread metastases undergoing systemic therapy present with a solitary or a few metastatic tumors that progress, while all other metastases are stable or responding. The usual practice would be to change systemic therapy at this point, but another approach is to locally ablate the "rogue" metastases and continue the same systemic therapy. SABR used in this scenario may delay the need to switch to another line of systemic therapy and improve progression-free survival while patients stay on the same systemic therapy.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
SABR-related toxicities — 12 months Incidence of acute and late toxicities (including radiation induced bone fractures) after comprehensive SABR to all progressing metastases seen on conventional imaging.
Progression-free survival — 24 months Time to clinical (i.e., radiological and/or symptomatic) progression following SABR.
Trial sites (1)
Facility
City
Region
Status
Odette Cancer Centre
Toronto
Ontario
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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