Brief Summary
The purpose of this study is to investigate the safety and efficacy of stereotactic ablative body radiotherapy (SABR) plus Avelumab in patients with metastatic castration-resistant prostate cancer (mCRPC).
Intervention/Treatment
- Intervention: SABR (stereotactic ablative body radiosurgery).
- Drug: Avelumab
Inclusion Criteria
- 18 years of age.
- Willing and able to provide informed written consent.
- Life expectancy of at least 6 months.
- Adenocarcinomacancer arising from mucus-producing glands in organs of the prostate diagnosed histologically without small cell differentiation.
- Prior surgical orchiectomyremoval of one or both testicles, also known as orchidectomy or maintained on luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy.
- Prior treatment with 1 of the following agents: CYP17 inhibitors (including abiraterone acetate (ABI), TAK-700, TOK-001 and ketoconazole), enzalutamide or other experimental anti-androgens (e.g. ARN-509, TOK-001).
- Prior treatment with up to 1 line of systemic chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells for mCRPC is permitted.
- Evidence of biochemical or imaging progression in the setting of surgical or medical castration. PD for study entry is defined by one of the following three criteria:
- PSA progression: minimum of two rising PSA values from a baseline measurement with an interval of 1 week between each measurement.
- Soft tissue or visceral disease progression as per RECIST 1.1 criteria.
- Bone progression: 2 new lesions on bone scana type of medical imaging that uses a radioactive tracer to detect bone conditions or abnormalities.
- Radiographic evidence of metastatic disease documented with bone scan or CT scan. Patients with any number of metastatic sites are permitted to enrol.
- Adequate organ function laboratory values:
- Absolute neutrophil count (ANC) at 1.5 x 109/L.
- Platelets at 100 x 109/L.
- Hemoglobin at 9 g/dL.
- Creatinine at 1.5 X upper limit of normal (ULN) OR at 60 mL/min calculated creatinine clearance for subject with creatinine levels greater than 1.5 X ULN.
- Serum total bilirubin at 1.5 X ULN OR direct bilirubin at ULN for participants with total bilirubin levels greater than 1.5 ULN.
- Aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) at 2.5 X ULN OR at 5 X ULN for participants with liver metastases.
- International normalised ratio (INR)/activated partial prothrombin time (aPTT) at 1.5 X ULN unless subject is receiving anticoagulantmedication used to prevent or reduce blood clots; also known as blood thinners therapy as long as prothrombin time (PT) or partial prothrombin time (PTT) is within therapeutic range of intended use of anticoagulants.
- Eastern cooperative oncology group (ECOG) performance status 0-1.
- Be willing and able to comply with all study requirements, including treatment, attending assessments and follow-up.
- Participants should agree to use a highly efficient method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.