Prostate CancerPhase 2KHADNCT00673127
Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
A Phase 2 study testing Ketoconazole, Hydrocortisone and Dutasteride in people with Prostate Cancer, run by Beth Israel Deaconess Medical Center at 7 sites in 2 countries.
Trial summary
The combination of ketaconazole and hydrocortisone is commonly used for the treatment of prostate cancer. The purpose of this study is to determine if the addition of a drug called dutasteride to this approved combination will make the combination more effective in treating prostate cancer. 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?
- Ketoconazole, Hydrocortisone and Dutasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Feb 2005to Dec 2012
- 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 documented evidence of prostate cancer (needle biopsy or prostatectomy). In the abscence of histologically documented evidence of prostate cancer, the diagnosis must be based on elevated serum PSA and metastatic lesions on bone scan.
- Progressive HRPC defined as a PSA increase over baseline of >25% or 5ng/ml or new lesions on bone/CT scan after conventional androgen deprivation and antiandrogen withdrawal. Evidence of metastatic disease based on positive CT or bone scan is not required.
- PSA of greater than or equal to 2ng/ml and serum total testosterone less than or equal to 50ng/ml
- Prior chemotherapy is permitted if discontinued > 4 weeks prior to starting therapy
- Prior therapy with estrogens is permitted but must have been discontinued > 4 weeks prior to registration
- ECOG Performance Status 0-2
- Adequate renal function, hepatic function, and bone marrow function as outlined in protocol
- ECG showing a normal QT interval
Who cannot join
- Prior therapy with ketoconazole or corticosteroids for HRPC
- Major surgery or radiation therapy within 4 weeks
- Strontium-89 or samarium-153 therapy within 4 weeks
- Thromboembolism in past 6 months
- Patients who are taking drugs that may further prolong QT intervals and present a known risk for Torsades de Pointes.
- Concomitant use of drugs known to be narrow therapeutic index CTP3A4
- Drugs that are sensitive CYP3A4 substrates
- Alcohol or drug dependence currently or in the last 6 months
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Sidney Kimmel Comprehensive Cancer Center at John Hopkins University
Baltimore, Maryland
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02214
MD Anderson Cancer Center
Houston, Texas
Oregon Health and Science University
Portland, Oregon
About this study
Official title: A Phase II Trial of Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
The combination of ketaconazole and hydrocortisone is commonly used for the treatment of prostate cancer. The purpose of this study is to determine if the addition of a drug called dutasteride to this approved combination will make the combination more effective in treating prostate cancer.
Read the detailed description
- Participants will be seen by the study physician every four weeks and have a short physical examination, blood tests and be asked to provide information about their condition. Every three months they will undergo a bone scan. If the CT scan that was obtained before the participant started the study shows evidence of cancer, they will be asked to repeat this test every three months.
- Ketaconazole will be taken orally three times a day on an empty stomach. Hydrocortisone will be taken orally in the morning and at night. Dutasteride will be taken orally once a day.
- Participants may remain on study drug until there is evidence of disease progression.
- Conditions
- Prostate Cancer
- Being tested
- Ketoconazole, Hydrocortisone and Dutasteride
- Keywords
- hormone refractory, KHAD, ketoconazole, dutasteride, hydrocortisone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketoconazole, Hydrocortisone and DutasterideDrug
Also called Dutasteride=Avodart
Ketoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Pills should be taken with food or milk.
Dutasteride: 0.5mg orally once a day on an empty stomach or after eating a meal
| Study group | Role | What they receive |
|---|---|---|
| KHAD | Experimental | Ketoconazole, Hydrocortisone and Dutasteride Ketoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Dutasteride: 0.5 mg once a day Receives: Drug: Ketoconazole, Hydrocortisone and Dutasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA Response
PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.
Measured: From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months.
Secondary outcomes (1)
Time to Progression
Duration of time from treatment initiation until documented progression (PSA or Disease progression)
Measured: Duration of time from treatment initiation until documented progression. Maximum 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startFeb 2005
- Primary completionFeb 2012
- Study completionDec 2012
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 Beth Israel Deaconess Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Dana-Farber Cancer Institute, Sunnybrook Health Sciences Centre, Oregon Health and Science University, M.D. Anderson Cancer Center, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Responsible party
- Principal investigator, Steven Balk, MD, Dana-Farber Cancer Institute
- Investigators
- Steven Balk, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673127
- Sponsor's protocol ID
- 04-414
- Acronym
- KHAD
- Status last verified
- Apr 2015
- First submitted
- 5 May 2008
- Last updated
- 22 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00673127
- Acronym / sponsor ID
- KHAD / 04-414
- Conditions
- Prostate Cancer
- Keywords
- hormone refractory, KHAD, ketoconazole, dutasteride, hydrocortisone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Dana-Farber Cancer Institute, Sunnybrook Health Sciences Centre, Oregon Health and Science University, M.D. Anderson Cancer Center, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Study start
- Feb 2005
- Primary completion
- Feb 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Posted 22 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The combination of ketaconazole and hydrocortisone is commonly used for the treatment of prostate cancer. The purpose of this study is to determine if the addition of a drug called dutasteride to this approved combination will make the combination more effective in treating prostate cancer.
Detailed description
- Participants will be seen by the study physician every four weeks and have a short physical examination, blood tests and be asked to provide information about their condition. Every three months they will undergo a bone scan. If the CT scan that was obtained before the participant started the study shows evidence of cancer, they will be asked to repeat this test every three months.
- Ketaconazole will be taken orally three times a day on an empty stomach. Hydrocortisone will be taken orally in the morning and at night. Dutasteride will be taken orally once a day.
- Participants may remain on study drug until there is evidence of disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KHAD | Experimental | Drug: Ketoconazole, Hydrocortisone and DutasterideKetoconazole, Hydrocortisone and Dutasteride Ketoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Dutasteride: 0.5 mg once a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically documented evidence of prostate cancer (needle biopsy or prostatectomy). In the abscence of histologically documented evidence of prostate cancer, the diagnosis must be based on elevated serum PSA and metastatic lesions on bone scan.
- Progressive HRPC defined as a PSA increase over baseline of >25% or 5ng/ml or new lesions on bone/CT scan after conventional androgen deprivation and antiandrogen withdrawal. Evidence of metastatic disease based on positive CT or bone scan is not required.
- PSA of greater than or equal to 2ng/ml and serum total testosterone less than or equal to 50ng/ml
- Prior chemotherapy is permitted if discontinued > 4 weeks prior to starting therapy
- Prior therapy with estrogens is permitted but must have been discontinued > 4 weeks prior to registration
Key exclusion criteria (8 listed)
- Prior therapy with ketoconazole or corticosteroids for HRPC
- Major surgery or radiation therapy within 4 weeks
- Strontium-89 or samarium-153 therapy within 4 weeks
- Thromboembolism in past 6 months
- Patients who are taking drugs that may further prolong QT intervals and present a known risk for Torsades de Pointes.
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 |
|---|---|---|
| Ketoconazole, Hydrocortisone and DutasterideAlso: Dutasteride=AvodartKetoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Pills should be taken with food or milk. Dutasteride: 0.5mg orally once a day on an empty stomach or after eating a meal | Drug | KHAD |
Primary outcome
PSA Response
Time frame: From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months.
PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.
1 secondary outcome
Time to Progression
Time frame: Duration of time from treatment initiation until documented progression. Maximum 32 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- 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.
Steven Balk, MD principal investigator
Beth Israel Deaconess Medical Center
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketoconazole, Hydrocortisone and Dutasteride in people with Prostate Cancer, run by Beth Israel Deaconess Medical Center at 7 sites in 2 countries.
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 8 inclusion and 8 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 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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 22 Apr 2015). 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?
PSA Response (time frame: From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months.). 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 22 Apr 2015.