NCT04838899 Stereotactic Ablative Radiation Therapy for Abiraterone-Resistant, Oligoprogressive Metastatic Prostate Cancer
| NCT ID | NCT04838899 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Oligoprogressive |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2016-07-16 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2016-07-16 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04838899 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Oligoprogressive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04838899 currently recruiting?
Yes, NCT04838899 is actively recruiting participants. Contact the research team at urban.emmenegger@sunnybrook.ca for enrollment information.
Where is the NCT04838899 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04838899 clinical trial?
NCT04838899 is sponsored by Sunnybrook Health Sciences Centre. The trial plans to enroll 30 participants.