Idronoxil Suppository Combine With Radiotherapy for Metastatic Prostate Cancer

• Status: Terminated
• Trial end date: 2019-09-17
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of the study is to determine the toxicity of Idronoxil (NOX66) when used in combination with palliative radiotherapy for metastatic prostate cancer

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal North Shore Hospital

Criteria

Inclusion Criteria:

• Confirmed metastatic prostate cancer that is castrate-resistant.

• 2-3 lesions suitable for radiotherapy.

• ECOG Performance status 0-2.

• Adequate bone marrow, hepatic and renal function

• At least 4 weeks must have elapsed prior to commencement of idronoxil treatment since prior chemotherapy, investigational drug or biologic therapy

Exclusion Criteria:

• Chemotherapy regimens with delayed toxicity within the last 4 weeks.

• Any situation where the use of suppository therapy is contra-indicated or impractical(eg. chronic diarrhoea, colostomy, ulcerative colitis).

• No concurrent systemic chemotherapy or biologic therapy is allowed.

• Psychiatric disorder or social or geographic situation that would preclude study participation.

• Patient unable to provide consent