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 prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (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 hormonea chemical substance produced by glands in the endocrine system that regulates various functions in the body (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 imagingtests that create detailed images of areas inside the body 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 tissuetissue/the material that joins, holds up or surrounds inside body parts such as fat, muscle, ligaments and lining around joints 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.
- Plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding 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 oncologythe study, diagnosis and treatment of cancer 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 dosethe amount of medication taken of study therapy through 120 days after the last dose of study therapy.