Idronoxil Suppository Combine With Radiotherapy for Metastatic Prostate Cancer

• ClinicalTrials.gov Identifier: NCT03041285
• Recruitment Status: Terminated
• First Posted: February 2, 2017
• Last Update Posted: September 20, 2019
• Sponsor: Royal North Shore Hospital
• Information provided by (Responsible Party): Associate Professor Thomas Eade, Royal North Shore Hospital

Study Description

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

Condition or disease	Intervention/treatment	Phase
Metastatic Castrate- Resistant Prostate Cancer	Drug: idronoxil (NOX66) suppository; Radiation: Stereotactic Body Radiation Therapy	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• 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.
• Masking: None (Open Label)
• Masking Description: There is no masking.
• Primary Purpose: Treatment
• Official Title: Phase I Study of Idronoxil Combined With Radiation Treatment in Men With Metastatic Prostate Cancer
• Actual Study Start Date: August 31, 2017
• Actual Primary Completion Date: September 17, 2019
• Actual Study Completion Date: September 17, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1 NOX66 400mg and SBRT; 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.	Drug: idronoxil (NOX66) suppository; Patients in Group 1 will be given 400mg of Idronoxil suppository (NOX66) (1 suppository) daily from Day 0(1 day before radiotherapy) until 7 days after radiotherapy. Group 2 will be given Idronoxil (NOX66) 800mg (2 suppositories) daily from Day 0 until 7 days after radiotherapy. All patients will receive one course of Stereotactic Body Radiation Therapy (SBRT), to be delivered in 20 Gray in 5 fractions. Radiotherapy session will involve irradiation of 1-2 lesions. .; Other Name: NOX66; Radiation: Stereotactic Body Radiation Therapy; All patients (Group 1 and Group 2) will receive one course of Stereotactic Body Radiation Therapy (SBRT), to be delivered in 20 Gray in 5 daily fractions on consecutive days. Radiotherapy session (week 1) will involve irradiation to 1-2 lesions.
Experimental: Group 2 NOX66 800mg and SBRT; 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.	Drug: idronoxil (NOX66) suppository; Patients in Group 1 will be given 400mg of Idronoxil suppository (NOX66) (1 suppository) daily from Day 0(1 day before radiotherapy) until 7 days after radiotherapy. Group 2 will be given Idronoxil (NOX66) 800mg (2 suppositories) daily from Day 0 until 7 days after radiotherapy. All patients will receive one course of Stereotactic Body Radiation Therapy (SBRT), to be delivered in 20 Gray in 5 fractions. Radiotherapy session will involve irradiation of 1-2 lesions. .; Other Name: NOX66; Radiation: Stereotactic Body Radiation Therapy; All patients (Group 1 and Group 2) will receive one course of Stereotactic Body Radiation Therapy (SBRT), to be delivered in 20 Gray in 5 daily fractions on consecutive days. Radiotherapy session (week 1) will involve irradiation to 1-2 lesions.

Outcome Measures

Primary Outcome Measures :

1. safety of Idronoxil dose escalation [ Time Frame: From start of NOX66 with stereotactic radiotherapy up to three months post treatment. ]
   Toxicity and relationship with study drug NOX66 will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V4.3

Secondary Outcome Measures :

1. evidence of clinical tumour response [ Time Frame: 3 months post treatment ]

   PSMA-PET CT will be done before and 3 months after treatment. The change in SUV in PSMA PET will be used to assess tumour metabolic response.

   Pre and post treatment tumour size on CT will be measured and RECIST criteria will be used to measure tumour response.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Australia, New South Wales

Royal North Shore Hospital

St Leonards, New South Wales, Australia, 2065

Sponsors and Collaborators

Royal North Shore Hospital

Investigators

• Principal Investigator: Thomas Eade; Northern Sydney Local Health District

More Information

• Responsible Party: Associate Professor Thomas Eade, Principal Investigator, Royal North Shore Hospital
• ClinicalTrials.gov Identifier: NCT03041285
• Other Study ID Numbers: NOX66 version 1
• First Posted: February 2, 2017
• Last Update Posted: September 20, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases