Stereotactic Ablative Radiotherapy for Oligoprogressive Metastatic Castration-Resistant Prostate Cancer During Abiraterone Therapy

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Odette Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
Urban Emmenegger, MD
urban.emmenegger@sunnybrook.ca
+416-480-4928
Time Frame
Start Date: 2016-07-16
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Treatment Arm
All metastases that fulfill the definition of oligoprogression seen on conventional imaging will be treated with standard SABR dose fractionation schemes routinely used at Sunnybrook Odette Cancer Centre. The prostate (if present and not previously treated) will be treated to a dose of 35 Gy in 5 fractions. Non-spine bone metastases will be treated to a dose of 30-40 Gy in 5 fractions. Spine metastases will be treated to a dose of 24 Gy in 2-3 fractions or 30-40 Gy in 5 fractions. Involved lymphadenopathy will be treated to a dose of 30-40 Gy in 5 fractions. Similarly, brain, lung, liver, and adrenal metastases will be treated with standard Sunnybrook SABR doses. Patients will remain on abiraterone during and after SABR treatments.
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov