The use of NOX66 as a tumour cell-specific sensitiser of radiation therapy may provide greater response to targeted radiation therapy within the tumour cells, with the tumour specific nature of NOX66 activity leading to no greater effect on non-tumour cells. As such, NOX66 is expected to increase the response to palliative dose radiation therapy, reducing target tumour size beyond those expected with palliative radiation therapy alone, with no significant increase in serious and severe adverse events.
- Provision of informed consent
- > 18 tears of age
- Histologically confirmed prostate cancer or PSA of >100 ng/mL at original diagnosis
- Metastatic disease evidenced by either CT/MRI imaging or bone scan
- Objective evidence of disease progression as defined by either:
- Radiographic progression of in nodal or visceral metastases and bone disease progression with 2 or more new lesions
- Rising PSA value >2ng/mL in at least 3 measurements, at least 1 week apart, with castrate levels of serum testosterone
- Eligible to receive palliative radiation therapy for management of disease
- At least two lesions, one of which is measurable and one which is suitable for radiation therapy
- ECOG Performance status 0-2
- A minimum life expectancy of 24 weeks
- Adequate bone marrow, hepatic and renal function
- Ongoing androgen deprivation therapy with luteinizing hormone releasing hormone (LHRH) agonist or antagonist
- At least 4 weeks must have elapsed prior to commencement of NOX66 treatment since prior chemotherapy, investigational drug or biologic therapy and any toxicity associated with these treatments has recover
- At least 21 days must have elapsed following major surgery and any surgical incision should be completely healed
- Tumour involvement of the central nervous system
- Uncontrolled infection or systemic disease
- Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease, angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months.
- Concurrent systemic chemotherapy or biological therapy
- Any situation where the use of suppository therapy is contra-indicated or impractical (eg. chronic diarrhoea, colostomy, ulcerative colitis).
- Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both)
- Any subject whose testosterone is not suppressed i.e. is > 0.5nmols/L
- Any other reason which, in the opinion of the investigator, will preclude suitable participation in the study.
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