Clinical trial NCT03041285: Idronoxil Suppository Combine With Radiotherapy for Metastatic Prostate Cancer
Official title: Phase I Study of Idronoxil Combined With Radiation Treatment in Men With Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Metastatic Castrate- Resistant Prostate Cancer
Lead sponsor: Royal North Shore Hospital
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Group 1 (6 participants) will receive 400mg of Idronoxil (NOX66) daily in the form of one suppository. Group 2 (6 participants) will receive 800mg of Idronoxil daily (two suppositories). Group 2 will only commence once all group 1 participants have completed their treatment course and have experienced no toxicity greater than grade 2 according CTCAE version 4.03 for adverse events assessment.
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: safety of Idronoxil dose escalation
timeFrame: From start of NOX66 with stereotactic radiotherapy up to three months post treatment.
Secondary outcomes:
measure: evidence of clinical tumour response
timeFrame: 3 months post treatment
Other outcomes:
Locations:
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
Study officials:
affiliation: Northern Sydney Local Health District
name: Thomas Eade
role: PRINCIPAL_INVESTIGATOR
References: