Prostate CancerPhase 2NCT00860158
Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer
A Phase 2 study testing Dasatinib, Leuprolide Acetate (LHRH Analogue) and Radical Prostatectomy in people with Prostate Cancer, run by Noah Hahn, M.D. at 6 sites in United States.
Trial summary
This trial will investigate the activity of dasatinib plus LHRH analogue therapy in high-risk localized 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?
- Dasatinib, Leuprolide Acetate (LHRH Analogue) and Radical Prostatectomy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2009to Dec 2010
- 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 confirmed adenocarcinoma of the prostate.
- Clinical stage T1-T3a disease.
- Must be willing to have a tumor biopsy, if previous tumor tissue unavailable for tumor marker analysis.
- Kattan pre-operative nomogram-predicted (based on stage, Prostate Specific Antigen (PSA) and Gleason score) 5-year risk of recurrence-free survival of 80% or less
- Must be deemed eligible for radical prostatectomy.
- Must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
- Written informed consent and HIPAA authorization for release of personal health information.
- Age > 18 years at the time of consent.
Who cannot join
- No evidence of regional, lymph node or distant metastasis on clinical or radiological assessments. All baseline radiology studies must be performed within 28 days prior to registration for protocol therapy.
- No prior malignancy in the past 2 years except for basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), and colonic polyp with focus of adenocarcinoma) can be enrolled after approval from the Sponsor Investigator.
- No prior hormonal therapy with the exception of oral 5-alpha-reductase inhibitors (finasteride, dutasteride, etc.). Patients who have received prior oral anti-androgen therapies (bicalutamide, flutamide, nilutamide, etc.), prior LHRH agonist therapy (leuprolide, goserelin acetate, etc.), or prior orchiectomy are ineligible.
- No prior systemic chemotherapy or radiotherapy for prostate cancer is allowed. Transurethral resection of the prostate for benign prostatic hypertrophy (BPH) and oral alpha-blockers (terazosin, tamsulosin, doxazosin) are permitted.
- No history of hemorrhage or thrombotic events (cerebrovascular accident, deep vein thrombosis, pulmonary embolism, etc.) within 6 months prior to registration for protocol therapy.
- No history of diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
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- No history of diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) of registration on protocol therapy.
- No history of ongoing or recent (≤ 3 months of registration on protocol therapy) significant gastrointestinal bleeding
- No ongoing anti-coagulation and/or anti-platelet therapies allowed.
- No unresolved pleural or pericardial effusion of any grade within 3 months of registration for protocol therapy.
- No uncontrolled angina, congestive heart failure or MI within 6 months prior to registration for protocol therapy.
- No diagnosed congenital long QT syndrome.
- No history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes).
- No prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)
- Following medications must be discontinued at least 7 days prior to registration for protocol therapy and be withheld for the duration of dasatinib therapy:
- Drugs that are generally accepted to have a risk of causing Torsades de Pointes
- Patient must not be receiving any prohibited CYP3A4 inhibitors /inducers/ substrates
- Anti-coagulation and/or anti-platelet therapies - to avoid potential bleeding risks.
- No major surgical procedure, open biopsy, or significant trauma within 28 days prior to registration for protocol therapy.
- Ability to comply with study and/or follow-up procedures and requirements.
- No treatment with any investigational agent for any medical condition within 28 days prior to registration for protocol therapy.
- No clinically significant infections or any other condition which, in the investigator's opinion, deems the patient an unsuitable candidate to receive the study drug.
- Ability to take oral medication (dasatinib must be swallowed whole).
- No known history of hypokalemia that cannot be corrected prior to registration on protocol therapy.
- No known history of hypomagnesemia that cannot be corrected prior to registration on protocol therapy.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Chicago
Chicago, Illinois, 60637
University of Florida
Gainesville, Florida, 32610
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
Virginia Oncology Associates
Norfolk, Virginia, 23502
Mayo Clinic Hospital
Scottsdale, Arizona, 85054
About this study
Official title: A Phase II Study of Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer
This trial will investigate the activity of dasatinib plus LHRH analogue therapy in high-risk localized prostate cancer.
Read the detailed description
OUTLINE: This is a multi-center study.
- Dasatinib -100 mg administered once daily per oral route for 28 consecutive days.
- Leuprolide acetate - 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).
The 28 days of dasatinib and leuprolide injection (plus the time required to recover from toxicity if encountered) is defined as a cycle. Patients will be treated for up to a maximum of 3 cycles of dasatinib and leuprolide acetate.
Radical Prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Hematopoietic:
- Hemoglobin (Hgb) ≥ 8.0 g/dL
- Platelets ≥ 100 K/mm3
- Absolute neutrophil count (ANC) ≥ 1.0 K/mm3
Hepatic:
- Total bilirubin < 2.0 X Upper Limit Normal (ULN)
- Aspartate aminotransferase (AST) < 2.5 X ULN
- Alanine aminotransferase (ALT) < 2.5 X ULN
Renal:
- Calculated creatinine clearance of ≥ 60 cc/min using the Cockcroft-Gault formula
Cardiovascular:
- No uncontrolled angina, congestive heart failure or myocardial infarction within 6 months prior to registration for protocol therapy.
- Conditions
- Prostate Cancer
- Being tested
- Dasatinib, Leuprolide Acetate (LHRH Analogue), Radical Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Dasatinib 100 mg administered once daily per oral route for 28 consecutive days
Leuprolide Acetate (LHRH Analogue)Drug
Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).
Radical ProstatectomyProcedure or surgery
Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Assignment | Experimental | Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy Receives: Drug: Dasatinib; Drug: Leuprolide Acetate (LHRH Analogue); Procedure: Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Estimate the Pathologic Complete Response (pCR) Rate
Measured: 18 months
Secondary outcomes (5)
To Estimate Partial Pathologic Responses (pPR)
Measured: 18 months
To Estimate PSA Response Rate
Measured: 18 months
To Estimate Progression Free Survival
Measured: 18 months
To Evaluate the Impact of Dasatinib Plus LHRH on Expression of Selected Biomarkers
Measured: 18 months
To Estimate Safety and Tolerability of LHRH Plus Dasatinib
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Slow accrual; closed by funder
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noah Hahn, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Noah Hahn, M.D., Hoosier Cancer Research Network
- Investigators
- Noah Hahn, M.D., Study chair, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860158
- Sponsor's protocol ID
- HOG GU07-124
- Status last verified
- Feb 2018
- First submitted
- 11 Mar 2009
- Last updated
- 14 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00860158
- Acronym / sponsor ID
- HOG GU07-124
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual; closed by funder
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Noah Hahn, M.D.University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Mar 2009 (estimated)
- Results
- Posted 5 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will investigate the activity of dasatinib plus LHRH analogue therapy in high-risk localized prostate cancer.
Detailed description
OUTLINE: This is a multi-center study.
- Dasatinib -100 mg administered once daily per oral route for 28 consecutive days.
- Leuprolide acetate - 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).
The 28 days of dasatinib and leuprolide injection (plus the time required to recover from toxicity if encountered) is defined as a cycle. Patients will be treated for up to a maximum of 3 cycles of dasatinib and leuprolide acetate.
Radical Prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Hematopoietic:
- Hemoglobin (Hgb) ≥ 8.0 g/dL
- Platelets ≥ 100 K/mm3
- Absolute neutrophil count (ANC) ≥ 1.0 K/mm3
Hepatic:
- Total bilirubin < 2.0 X Upper Limit Normal (ULN)
- Aspartate aminotransferase (AST) < 2.5 X ULN
- Alanine aminotransferase (ALT) < 2.5 X ULN
Renal:
- Calculated creatinine clearance of ≥ 60 cc/min using the Cockcroft-Gault formula
Cardiovascular:
- No uncontrolled angina, congestive heart failure or myocardial infarction within 6 months prior to registration for protocol therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Assignment | Experimental | Drug: Dasatinib, Drug: Leuprolide Acetate (LHRH Analogue), Procedure: Radical ProstatectomyNeoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy |
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 confirmed adenocarcinoma of the prostate.
- Clinical stage T1-T3a disease.
- Must be willing to have a tumor biopsy, if previous tumor tissue unavailable for tumor marker analysis.
- Kattan pre-operative nomogram-predicted (based on stage, Prostate Specific Antigen (PSA) and Gleason score) 5-year risk of recurrence-free survival of 80% or less
- Must be deemed eligible for radical prostatectomy.
Key exclusion criteria (25 listed)
- No evidence of regional, lymph node or distant metastasis on clinical or radiological assessments. All baseline radiology studies must be performed within 28 days prior to registration for protocol therapy.
- No prior malignancy in the past 2 years except for basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), and colonic polyp with focus of adenocarcinoma) can be enrolled after approval from the Sponsor Investigator.
- No prior hormonal therapy with the exception of oral 5-alpha-reductase inhibitors (finasteride, dutasteride, etc.). Patients who have received prior oral anti-androgen therapies (bicalutamide, flutamide, nilutamide, etc.), prior LHRH agonist therapy (leuprolide, goserelin acetate, etc.), or prior orchiectomy are ineligible.
- No prior systemic chemotherapy or radiotherapy for prostate cancer is allowed. Transurethral resection of the prostate for benign prostatic hypertrophy (BPH) and oral alpha-blockers (terazosin, tamsulosin, doxazosin) are permitted.
- No history of hemorrhage or thrombotic events (cerebrovascular accident, deep vein thrombosis, pulmonary embolism, etc.) within 6 months prior to registration for protocol therapy.
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 |
|---|---|---|
| DasatinibDasatinib 100 mg administered once daily per oral route for 28 consecutive days | Drug | Single Arm Assignment |
| Leuprolide Acetate (LHRH Analogue)Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days). | Drug | Single Arm Assignment |
| Radical ProstatectomyRadical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose. | Procedure or surgery | Single Arm Assignment |
Primary outcome
To Estimate the Pathologic Complete Response (pCR) Rate
Time frame: 18 months
5 secondary outcomes
To Estimate Partial Pathologic Responses (pPR)
Time frame: 18 months
To Estimate PSA Response Rate
Time frame: 18 months
To Estimate Progression Free Survival
Time frame: 18 months
To Evaluate the Impact of Dasatinib Plus LHRH on Expression of Selected Biomarkers
Time frame: 18 months
To Estimate Safety and Tolerability of LHRH Plus Dasatinib
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Hoosier Oncology Group HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Noah Hahn, M.D. study chair
Hoosier Cancer Research Network
6 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 Dasatinib, Leuprolide Acetate (LHRH Analogue) and Radical Prostatectomy in people with Prostate Cancer, run by Noah Hahn, M.D. at 6 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 25 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 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 5 Feb 2016). 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 Estimate the Pathologic Complete Response (pCR) Rate (time frame: 18 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 14 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.