Prostate CancerPhase 2NCT00887458
A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy
A Phase 2 study testing Itraconazole 200 mg and Itraconazole 300mg in people with Prostate Cancer, run by Johns Hopkins University at 4 sites in United States.
Trial summary
This research is being done to test an investigational drug, called itraconazole, in the treatment of prostate cancer. Itraconazole is approved by the Food and Drug Administration (FDA) for the treatment of various fungal infections such as fingernail/toenail infections and other more serious fungal infections. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Itraconazole 200 mg and Itraconazole 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2009to Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Presence of distant metastases on bone scan, CT scan, or MRI scan.
- Progression after androgen deprivation (and anti-androgen withdrawal).
- Rising serum PSA (Prostate Cancer Working Group (PCWG2) definition).
- Castrate levels of serum testosterone (i.e., ≤ 50 ng/dL).
- Age > 18 years.
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- ECOG performance status score ≤ 2, and/or Karnofsky score ≥ 50%.
- Life expectancy > 6 months.
- Adequate kidney, liver, and bone marrow function.
- Willingness to sign informed consent and adhere to study requirements.
Who cannot join
- Recent surgery, radiation therapy, combined androgen blockade, or investigational therapies in the last 8 weeks.
- Previous chemotherapy for metastatic prostate cancer.
- Concomitant use of second-line hormonal agents (e.g., ketoconazole, DES)
- Current use of corticosteroids, except if on a stable dose for ≥ 3 months.
- History of malabsorption syndrome (may affect itraconazole absorption).
- Allergic reactions to itraconazole or similar compounds.
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- Concurrent use of drugs that interact with the CYP3A4 system (caution only).
- Presence of known brain metastases.
- Prior malignancy in the last 3 years, with some exceptions.
- Uncontrolled major infectious, cardiac, or pulmonary illnesses.
- Prolonged corrected QT interval (> 450 msec) on electrocardiography.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Johns Hopkins Hospital
Baltimore, Maryland, 21231
Karmanos Cancer Center
Detroit, Michigan, 48201
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Randomized Phase II Clinical Trial of Two Dose-levels of Itraconazole in Patients With Metastatic Castration-resistant Prostate Cancer
This research is being done to test an investigational drug, called itraconazole, in the treatment of prostate cancer. Itraconazole is approved by the Food and Drug Administration (FDA) for the treatment of various fungal infections such as fingernail/toenail infections and other more serious fungal infections. The word "investigational" means that itraconazole is not approved for use in people with cancer. However, the FDA is allowing the use of itraconazole in this research study. Itraconazole has been shown to have activity against cancer (including prostate cancer) in the laboratory, but has not been tested against cancer in humans.
The purpose of this study is to find out:
- If itraconazole is safe when given at two different doses
- How itraconazole affects prostate specific antigen (PSA): a blood test that measures substances released by prostate cancer
- Whether itraconazole can delay further prostate cancer growth and spread
- How itraconazole affects other markers of prostate cancer
Read the detailed description
Itraconazole is an oral, generic, and commercially available antifungal drug with a long safety record when used at doses ranging from 200 to 600 mg daily.
Itraconazole has been shown in cellular and animal models to be a potent angiogenesis inhibitor as well as a Hedgehog pathway antagonist; both pathways are considered important in prostate cancer. Itraconazole has not previously been tested as an antineoplastic agent, but given its well-established safety profile, the gap between further preclinical studies and human clinical trials can be narrowed to accelerate development of this agent as a putative anticancer drug. The investigators hypothesize that itraconazole will prevent PSA progression in a significant proportion of men with metastatic CRPC and that it will have an acceptable safety profile at both doses. Itraconazole may ultimately delay the need for chemotherapy in these men.
- Conditions
- Prostate Cancer
- Being tested
- Itraconazole 200 mg, Itraconazole 300mg
- Keywords
- metastatic prostate cancer, castration resistant prostate cancer, rising PSA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itraconazole 200 mgDrug
Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)
Itraconazole 300mgDrug
Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Active comparator | Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) Receives: Drug: Itraconazole 200 mg |
| High Dose | Active comparator | Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose) Receives: Drug: Itraconazole 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy With One of Two Dose-levels of Itraconazole: 200 mg or 600 mg Daily.
To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy. "PSA progression" is defined as a 25% increase in PSA over baseline [or nadir (lowest)] and an increase in absolute PSA level by at least 2 ng/mL, both confirmed by a second value at least 4 weeks later.
Measured: Up to 24 weeks
Secondary outcomes (1)
To Determine the Proportion of Men With ≥ 50% PSA Reduction From Baseline.
Will be reported as the percentage of men with ≥ 50% PSA reduction from baseline.
Measured: Baseline and approximately 2 years from open enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor
- Investigators
- Michael A Carducci, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887458
- Sponsor's protocol ID
- J0932
- Other IDs
- JHMI-IRB number: NA_00027099
- Status last verified
- Sep 2017
- First submitted
- 23 Apr 2009
- Last updated
- 16 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Clinical Trial of Two Dose-levels of Itraconazole in Patients With Metastatic Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT00887458
- Acronym / sponsor ID
- J0932
- Conditions
- Prostate Cancer
- Keywords
- metastatic prostate cancer, castration resistant prostate cancer, rising PSA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Study start
- Jul 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Apr 2009 (estimated)
- Results
- Posted 27 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to test an investigational drug, called itraconazole, in the treatment of prostate cancer. Itraconazole is approved by the Food and Drug Administration (FDA) for the treatment of various fungal infections such as fingernail/toenail infections and other more serious fungal infections. The word "investigational" means that itraconazole is not approved for use in people with cancer. However, the FDA is allowing the use of itraconazole in this research study. Itraconazole has been shown to have activity against cancer (including prostate cancer) in the laboratory, but has not been tested against cancer in humans.
The purpose of this study is to find out:
- If itraconazole is safe when given at two different doses
- How itraconazole affects prostate specific antigen (PSA): a blood test that measures substances released by prostate cancer
- Whether itraconazole can delay further prostate cancer growth and spread
- How itraconazole affects other markers of prostate cancer
Detailed description
Itraconazole is an oral, generic, and commercially available antifungal drug with a long safety record when used at doses ranging from 200 to 600 mg daily.
Itraconazole has been shown in cellular and animal models to be a potent angiogenesis inhibitor as well as a Hedgehog pathway antagonist; both pathways are considered important in prostate cancer. Itraconazole has not previously been tested as an antineoplastic agent, but given its well-established safety profile, the gap between further preclinical studies and human clinical trials can be narrowed to accelerate development of this agent as a putative anticancer drug. The investigators hypothesize that itraconazole will prevent PSA progression in a significant proportion of men with metastatic CRPC and that it will have an acceptable safety profile at both doses. Itraconazole may ultimately delay the need for chemotherapy in these men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Active comparator | Drug: Itraconazole 200 mgItraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) |
| High Dose | Active comparator | Drug: Itraconazole 300mgItraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Presence of distant metastases on bone scan, CT scan, or MRI scan.
- Progression after androgen deprivation (and anti-androgen withdrawal).
- Rising serum PSA (Prostate Cancer Working Group (PCWG2) definition).
- Castrate levels of serum testosterone (i.e., ≤ 50 ng/dL).
Key exclusion criteria (11 listed)
- Recent surgery, radiation therapy, combined androgen blockade, or investigational therapies in the last 8 weeks.
- Previous chemotherapy for metastatic prostate cancer.
- Concomitant use of second-line hormonal agents (e.g., ketoconazole, DES)
- Current use of corticosteroids, except if on a stable dose for ≥ 3 months.
- History of malabsorption syndrome (may affect itraconazole absorption).
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 |
|---|---|---|
| Itraconazole 200 mgItraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) | Drug | Low Dose |
| Itraconazole 300mgItraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose) | Drug | High Dose |
Primary outcome
To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy With One of Two Dose-levels of Itraconazole: 200 mg or 600 mg Daily.
Time frame: Up to 24 weeks
To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy. "PSA progression" is defined as a 25% increase in PSA over baseline [or nadir (lowest)] and an increase in absolute PSA level by at least 2 ng/mL, both confirmed by a second value at least 4 weeks later.
1 secondary outcome
To Determine the Proportion of Men With ≥ 50% PSA Reduction From Baseline.
Time frame: Baseline and approximately 2 years from open enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael A Carducci, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Itraconazole 200 mg and Itraconazole 300mg in people with Prostate Cancer, run by Johns Hopkins University at 4 sites in United States.
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 10 inclusion and 11 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: finished, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy With One of Two Dose-levels of Itraconazole: 200 mg or 600 mg Daily. (time frame: Up to 24 weeks). 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 16 Oct 2017; AzTrials last refreshed its copy on 8 Nov 2026.