NCT04838899Recruiting
Stereotactic Ablative Radiation Therapy for Abiraterone-Resistant, Oligoprogressive Metastatic Prostate Cancer
Stereotactic Ablative Radiotherapy for Oligoprogressive Metastatic Castration-Resistant Prostate Cancer During Abiraterone Therapy
Source: ClinicalTrials.gov · Last updated 12 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 3 Apr 2021
- Start date
- 16 Jul 2016
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Prostate cancer
- NCT number
- NCT04838899
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 16 Jul 2016 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, and in-situ cancer.
Other
- Evidence of spinal cord compression.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Odette Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.