Metastatic Castrate- Resistant Prostate CancerPhase 1NCT03041285
Idronoxil Suppository Combine With Radiotherapy for Metastatic Prostate Cancer
A Phase 1 study testing idronoxil (NOX66) suppository and Stereotactic Body Radiation Therapy in people with Metastatic Castrate- Resistant Prostate Cancer, run by Royal North Shore Hospital at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castrate- Resistant Prostate Cancer
- What is being tested?
- idronoxil (NOX66) suppository and Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteAustralia
- Study dates
- 31 Aug 2017to 17 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Australia1 site
Royal North Shore Hospital
St Leonards, New South Wales, 2065
About this study
Official title: Phase I Study of Idronoxil Combined With Radiation Treatment in Men With Metastatic Prostate Cancer
The aim of the study is to determine the toxicity of Idronoxil (NOX66) when used in combination with palliative radiotherapy for metastatic prostate cancer
Read the 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.
- Being tested
- idronoxil (NOX66) suppository, Stereotactic Body Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
idronoxil (NOX66) suppositoryDrug
Also called NOX66
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.
.
Stereotactic Body Radiation TherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 NOX66 400mg and SBRT | Experimental | 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. Receives: Drug: idronoxil (NOX66) suppository; Radiation: Stereotactic Body Radiation Therapy |
| Group 2 NOX66 800mg and SBRT | Experimental | 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. Receives: Drug: idronoxil (NOX66) suppository; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of Idronoxil dose escalation
Toxicity and relationship with study drug NOX66 will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V4.3
Measured: From start of NOX66 with stereotactic radiotherapy up to three months post treatment.
Secondary outcomes (1)
evidence of clinical tumour response
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.
Measured: 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start31 Aug 2017
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Why it stopped: have difficulty finding eligible participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castrate- Resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal North Shore Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Thomas Eade, Royal North Shore Hospital
- Investigators
- Thomas Eade, Principal investigator, Northern Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041285
- Sponsor's protocol ID
- NOX66 version 1
- Status last verified
- May 2022
- First submitted
- 20 Jan 2017
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Idronoxil Combined With Radiation Treatment in Men With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT03041285
- Acronym / sponsor ID
- NOX66 version 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: have difficulty finding eligible participants
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Royal North Shore HospitalUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 NOX66 400mg and SBRT | Experimental | Drug: idronoxil (NOX66) suppository, Radiation: Stereotactic Body Radiation TherapyGroup 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. |
| Group 2 NOX66 800mg and SBRT | Experimental | Drug: idronoxil (NOX66) suppository, Radiation: Stereotactic Body Radiation TherapyGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed metastatic prostate cancer that is castrate-resistant.
- 2-3 lesions suitable for radiotherapy.
- ECOG Performance status 0-2.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| idronoxil (NOX66) suppositoryAlso: NOX66Patients 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. . | Drug | Group 1 NOX66 400mg and SBRT, Group 2 NOX66 800mg and SBRT |
| Stereotactic Body Radiation TherapyAll 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. | Radiation | Group 1 NOX66 400mg and SBRT, Group 2 NOX66 800mg and SBRT |
Primary outcome
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
1 secondary outcome
evidence of clinical tumour response
Time frame: 3 months post treatment
Results and safety
The study was stopped early (reason given: have difficulty finding eligible participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No
Related trials for Metastatic Castrate- Resistant Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
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RADIANT: A Study of Radium-223 Dichloride (Xofigo) vs Enzalutamide or Abiraterone (ARPIs, Androgen Receptor Pathway Inhibitors) in Patients With Prostate Cancer That Has Spread to the Bones (mCRPC, Metastatic Castration-Resistant Prostate Cancer)
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Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer
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An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)
Progressive Metastatic Castrate Resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Eade principal investigator
Northern Sydney Local Health District
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing idronoxil (NOX66) suppository and Stereotactic Body Radiation Therapy in people with Metastatic Castrate- Resistant Prostate Cancer, run by Royal North Shore Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: have difficulty finding eligible participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety of Idronoxil dose escalation (time frame: From start of NOX66 with stereotactic radiotherapy up to three months post treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.