Idronoxil Suppository Combine With Radiotherapy for Metastatic Prostate Cancer

Royal North Shore Hospital

Status and phase: Terminated; Phase 1

Conditions: Metastatic Castrate- Resistant Prostate Cancer

Treatments: Radiation: Stereotactic Body Radiation Therapy; Drug: idronoxil (NOX66) suppository

Study type: Interventional

Funder types: Other

Identifiers

NCT03041285

NOX66 version 1

Details and patient eligibility

About

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

Full description

Who is it for? Patient may be eligible for this study if they have late stage metastatic prostate cancer which is castrate resistant and have metastatic lesions that are suitable for radiotherapy.

Study details There are two groups of patients in this study and no randomisation. The two groups will have two different doses of idronoxil (NOX66), representing a 2-step dose escalation. Both groups receive the same standard radiotherapy dose.

Group 1 will receive the lower dose (400 mg) of idronoxil suppository daily and Group 2 800 mg daily.

Recruitment into Group 2 will only commence once all Group 1 patients have completed the 13-day treatment course of idronoxil suppository without excessive unexpected toxicity. The total treatment duration will be 13-15 days for both groups depends on whether radiotherapy is given on consecutive days or over the weekend.

Day 0: commence idronoxil (NOX66) Days 1-5: 1 or 2 lesions will receive 20 Gy (radiotherapy dose unit) radiotherapy in 5 daily fractionated doses and continue daily NOX66 Day 6-12: Continue NOX66 (the duration of NOX66 will be 13-15 days depends on whether radiotherapy is given on consecutive days or over the weekend).

Both groups will have prostate-specific membrane antigen positron emission tomography (PSMA-PET) scans before starting treatment and three months after the last fraction of radiotherapy to assess treatment response.

Enrollment: 1 patient

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Group 1 NOX66 400mg and SBRT

Experimental group

Description:

Group 1 patients will receive 400mg of Idronoxil (NOX66) suppository (1 suppository) daily from Day 0 (1 day before radiotherapy) until 7 days after completion of radiotherapy. Stereotactic Body Radiation Therapy will be given on Days1-5 (5 fractions). Total treatment course is 13-15 days, depends on whether radiotherapy is given on consecutive days or over the weekend.

Treatment:

Drug: idronoxil (NOX66) suppository

Radiation: Stereotactic Body Radiation Therapy

Group 2 NOX66 800mg and SBRT

Experimental group

Description:

Group 2 patients will receive 800mg of Idronoxil (NOX66) suppository (2 suppositories) daily from Day 0 (1 day before radiotherapy) until 7 days after completion of radiotherapy. Stereotactic Body Radiation Therapy will be given on Days1-5 (5 fractions). Total treatment course is 13-15 days, depends on whether radiotherapy is given on consecutive days or over the weekend.

Treatment:

Drug: idronoxil (NOX66) suppository

Radiation: Stereotactic Body Radiation Therapy