Stereotactic Ablative Radiation Therapy for Abiraterone-Resistant, Oligoprogressive Metastatic Prostate Cancer

NCT04838899 | Recruiting

• 1 other identifier: #351
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• SABR-related toxicities

  Incidence of acute and late toxicities (including radiation induced bone fractures) after comprehensive SABR to all progressing metastases seen on conventional imaging.

  12 months

• Progression-free survival

  Time to clinical (i.e., radiological and/or symptomatic) progression following SABR.

  24 months

Secondary Outcomes (6)

• Biochemical progression-free survival

  24 months

• Time to changing systemic therapy

  24 months

• Radiographic local control rate of the SABR-treated areas

  24 months

• Radiographic distant progression-free survival

  24 months

• Overall survival

  36 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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.

Radiation: Stereotactic Body Radiation Therapy (SABR)

Interventions

Stereotactic Body Radiation Therapy (SABR) RADIATION

SABR to oligoprogressive metastases while continuing abiraterone therapy

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Odette Cancer Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Urban Emmenegger, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: April 3, 2021
• First Posted: April 9, 2021
• Study Start: July 16, 2016
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

CA (1)