Recruiting

Stereotactic Ablative Radiation Therapy

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04838899

Conditions

Oligoprogressive

Castration-Resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Body Radiation Therapy (SABR)

Study Details

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.

Conditions

Oligoprogressive

Castration-Resistant Prostate Cancer

Study ID

NCT04838899

Start date

Jul 16, 2016

Status verified date

Apr, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Stereotactic Body Radiation Therapy (SABR)

SABR to oligoprogressive metastases while continuing abiraterone therapy

Primary outcome measure

  • SABR-related toxicities [ Time Frame: 12 months ]
  • Progression-free survival [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Urban Emmenegger, MD

+416-480-4928urban.emmenegger@sunnybrook.ca

Locations

Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

Urban Emmenegger, MD

+1-416-480-4928urban.emmenegger@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Apr 12, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2024-04-12.