Prostate CancerPhase 2NCT00668642
Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer
A Phase 2 study testing Dutasteride in people with Prostate Cancer, run by Endeavor Health at 3 sites in United States.
Trial summary
The purpose of this study is to determine if the drug dutasteride increases expression of genes that slow the growth of prostate cancer during treatment with intermittent androgen ablation therapy (hormone therapy). 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?
- Dutasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2007to May 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 proven prostate cancer
- Patients are hormone-naive
- Patients either to begin androgen ablation therapy with luteinizing hormone-releasing hormone (LHRH) agonist or already receiving therapy with LHRH agonist
- Advanced prostate cancer with either positive pelvic nodes or bone/visceral metastasis
- Must have an intact prostate (no previous surgery or XRT)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Recovery from any major infection or surgical procedure
- Signed informed consent
Who cannot join
- Known intolerance or allergy to dutasteride
- Concomitant chemotherapy, biologic therapy, or XRT to prostate
- Bilateral orchiectomy
- Prior malignancy within 5 years of registration
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern University Medical Center
Chicago, Illinois, 60611
University of Chicago Hospitals and Clinics
Chicago, Illinois, 60637
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
Official title: Effect of Dutasteride on Androgen-Response Gene Expression During the Tumor Regrowth Phase of Intermittent Androgen Ablation Therapy in Patients With Advanced Prostate Cancer
The purpose of this study is to determine if the drug dutasteride increases expression of genes that slow the growth of prostate cancer during treatment with intermittent androgen ablation therapy (hormone therapy).
Read the detailed description
We have shown in a murine model of treatment with intermittent androgen ablation therapy of prostate cancer that when dutasteride is given during the regrowth phase (off-phase) of intermittent therapy, that tumor growth is inhibited and that survival is improved. We have also shown that testosterone is a more potent inducer of certain tumor suppressor androgen response genes than dihydrotestosterone. In this murine model, we showed that use of a 5-alpha reductase inhibitor (dutasteride) resulted in significant hyperinduction of the U19 tumor suppressor androgen response gene during the regrowth phase of treatment. In the current clinical trial, we will determine if use of dutasteride in men with advanced prostate cancer during the off-phase of intermittent androgen ablation therapy will also result in hyperinduction of these tumor suppressor androgen response genes. Gene expression will be measured in tumor tissue obtained by prostate biopsies during the off-phase when the testosterone level has normalized. Prostate-specific antigen (PSA) levels will also be measured to determine the PSA doubling time during the off-phase to determine the effect of dutasteride on PSA kinetics.
- Conditions
- Prostate Cancer
- Being tested
- Dutasteride, Placebo
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DutasterideDrug
Also called Avodart
0.5 mg capsule given orally on daily basis
PlaceboDrug
Identical placebo
| Study group | Role | What they receive |
|---|---|---|
| A: Dutasteride During First Off-Cycle | Experimental | Arm A patients received dutasteride (0.5 mg/day) during the first off-cycle and received placebo during the second off-cycle Receives: Drug: Dutasteride |
| B: Placebo During First Off-Cycle | Placebo comparator | Arm B patients received placebo during the first off-cycle and received dutasteride (0.5 mg/day) during the second off-cycle Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Expression of U19 Gene in Tumor From Prostate Gland During First Off-cycle.
Calculation of the level of gene expression of the U19 tumor suppressor gene compared between the 2 arms at the end of "off-treatment" cycle 1.
Measured: At the end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months)
Secondary outcomes (1)
Determination of Prostate-specific Antigen (PSA) Doubling Time During First Off-cycle
Calculation of number of months when baseline PSA doubles compared between the 2 arms at the end of "off-treatment" cycle 1.
Measured: At month 9 and ongoing monthly until end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startMar 2007
- Primary completionMay 2013
- Study completionMay 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.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago, Northwestern University
- Responsible party
- Principal investigator, Daniel Shevrin, Endeavor Health
- Investigators
- Daniel H Shevrin, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668642
- Sponsor's protocol ID
- EH07-109
- Status last verified
- Jul 2023
- First submitted
- 28 Apr 2008
- Last updated
- 22 Aug 2023
- 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 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dutasteride on Androgen-Response Gene Expression During the Tumor Regrowth Phase of Intermittent Androgen Ablation Therapy in Patients With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT00668642
- Acronym / sponsor ID
- EH07-109
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- University of Chicago, Northwestern University
- Study start
- Mar 2007 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Posted 22 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the drug dutasteride increases expression of genes that slow the growth of prostate cancer during treatment with intermittent androgen ablation therapy (hormone therapy).
Detailed description
We have shown in a murine model of treatment with intermittent androgen ablation therapy of prostate cancer that when dutasteride is given during the regrowth phase (off-phase) of intermittent therapy, that tumor growth is inhibited and that survival is improved. We have also shown that testosterone is a more potent inducer of certain tumor suppressor androgen response genes than dihydrotestosterone. In this murine model, we showed that use of a 5-alpha reductase inhibitor (dutasteride) resulted in significant hyperinduction of the U19 tumor suppressor androgen response gene during the regrowth phase of treatment. In the current clinical trial, we will determine if use of dutasteride in men with advanced prostate cancer during the off-phase of intermittent androgen ablation therapy will also result in hyperinduction of these tumor suppressor androgen response genes. Gene expression will be measured in tumor tissue obtained by prostate biopsies during the off-phase when the testosterone level has normalized. Prostate-specific antigen (PSA) levels will also be measured to determine the PSA doubling time during the off-phase to determine the effect of dutasteride on PSA kinetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Dutasteride During First Off-Cycle | Experimental | Drug: DutasterideArm A patients received dutasteride (0.5 mg/day) during the first off-cycle and received placebo during the second off-cycle |
| B: Placebo During First Off-Cycle | Placebo comparator | Drug: PlaceboArm B patients received placebo during the first off-cycle and received dutasteride (0.5 mg/day) during the second off-cycle |
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 proven prostate cancer
- Patients are hormone-naive
- Patients either to begin androgen ablation therapy with luteinizing hormone-releasing hormone (LHRH) agonist or already receiving therapy with LHRH agonist
- Advanced prostate cancer with either positive pelvic nodes or bone/visceral metastasis
- Must have an intact prostate (no previous surgery or XRT)
Key exclusion criteria (4 listed)
- Known intolerance or allergy to dutasteride
- Concomitant chemotherapy, biologic therapy, or XRT to prostate
- Bilateral orchiectomy
- Prior malignancy within 5 years of registration
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 |
|---|---|---|
| DutasterideAlso: Avodart0.5 mg capsule given orally on daily basis | Drug | A: Dutasteride During First Off-Cycle |
| PlaceboIdentical placebo | Drug | B: Placebo During First Off-Cycle |
Primary outcome
Relative Expression of U19 Gene in Tumor From Prostate Gland During First Off-cycle.
Time frame: At the end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months)
Calculation of the level of gene expression of the U19 tumor suppressor gene compared between the 2 arms at the end of "off-treatment" cycle 1.
1 secondary outcome
Determination of Prostate-specific Antigen (PSA) Doubling Time During First Off-cycle
Time frame: At month 9 and ongoing monthly until end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- 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.
Daniel H Shevrin, MD principal investigator
Endeavor Health
3 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 Dutasteride in people with Prostate Cancer, run by Endeavor Health at 3 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 8 inclusion and 4 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 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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 Aug 2023). 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?
Relative Expression of U19 Gene in Tumor From Prostate Gland During First Off-cycle. (time frame: At the end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 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 Aug 2023.