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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorSunnybrook Health Sciences Centre

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

ECOG performance status 0-1.

Histologic confirmation of prostate adenocarcinoma.

Documentation of metastatic, castration-resistant prostate cancer.

Patient being treated with abiraterone.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Stereotactic Body Radiation Therapy (SABR)

    Radiation

    SABR to oligoprogressive metastases while continuing abiraterone therapy

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

Progression-free survival

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

Time frame
24 months

Secondary outcomes

1

Biochemical progression-free survival

Time to PSA progression

Time frame
24 months
2

Time to changing systemic therapy

Time to starting subsequent line of systemic therapy

Time frame
24 months
3

Radiographic local control rate of the SABR-treated areas

Monitoring lack of progression of oligoprogressive sites of disease

Time frame
24 months
4

Radiographic distant progression-free survival

Time to metastatic progression outside of SABR-treated areas

Time frame
24 months

Other outcomes

Sponsors and contacts

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