Prostate CancerPhase 2NCT00500110
Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer
A Phase 2 study testing Docetaxel, Imatinib Mesylate and Leuprolide in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: 1. To evaluate the pathological complete response rate to neoadjuvant hormonal ablation, Imatinib and Docetaxel (HID) in high-risk localized prostate cancer. Secondary Objectives: 1. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Docetaxel, Imatinib Mesylate and Leuprolide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Feb 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with adenocarcinoma of the prostate that in the opinion of the surgeon is resectable. Ductal adenocarcinoma of the prostate is included.
- All patients must be regarded as low anesthetic risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the neoadjuvant therapy.
- All patients must have at least one of the following high-risk features: clinical or pathological T3 disease, or cT2c or PSA>20ng/ml or Gleason 8-10 adenocarcinoma or clinical T2b and PSA>10ng/ml and Gleason 7 adenocarcinoma. The 1992 AJCC staging system will be followed.
- Prior hormonal therapy up to 2 months is permitted; no concurrent ketoconazole is permitted.
- Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,500/mm3 and platelet count of >/= 100,000/mm3; adequate hepatic function defined with a total bilirubin of </= 1.5 mg/dl and aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) </= 2 times the upper limits of normal; adequate renal function defined as serum creatinine clearance >/= 40 cc/min (measured or calculated).
- Patients must sign a written informed consent form prior to treatment. All patients must have a surgical and medical oncology consult prior to signing informed consent.
Who cannot join
- Patients with small cell or sarcomatoid prostate cancers are not eligible.
- Patients with clinical or radiological evidence of metastatic disease
- Prior chemotherapy or experimental agents
- Patients with severe intercurrent infection.
- Patients with The New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina or myocardial infarction (MI) in the last 6 months.
- Contraindications to corticosteroids.
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- Uncontrolled severe hypertension, uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease or human immunodeficiency virus (HIV) infection.
- Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years.
- Overt psychosis, mental disability or otherwise incompetent to give informed consent or history of non-compliance.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Neoadjuvant Hormonal Ablation, Imatinib Mesylate and Docetaxel Followed by Radical Prostatectomy for High-Risk Localized Prostate Cancer
Primary Objective:
- To evaluate the pathological complete response rate to neoadjuvant hormonal ablation, Imatinib and Docetaxel (HID) in high-risk localized prostate cancer.
Secondary Objectives:
- To describe the time to prostate specific antigen (PSA)-progression after neoadjuvant HID and radical prostatectomy in high-risk localized prostate cancer.
- To correlate pathological response with modulation of the Platelet-Derived Growth Factor Receptor (PDGFR) pathway.
Read the detailed description
Docetaxel is a drug that was designed to help kill cancer cells. Imatinib mesylate is a drug designed to block cancer cells from growing and dividing. Hormonal treatment with Lupron (leuprolide) or Zoladex (goserelin acetate) is used to lower testosterone levels in the body because prostate cancer cells need testosterone to survive. All patients will have their prostate gland removed after treatment with these drugs.
Before treatment starts, you will be asked questions about your medical history and have a complete physical examination. You will have blood drawn (2 tablespoons) for routine blood tests. You will be asked questions about any medications you are currently taking and have taken in the past. You will have an electrocardiogram (ECG - a test that measures electrical activity of the heart). As part of your standard care for prostate cancer, you will also have a computed tomography (CT) scan (or magnetic resonance imaging ((MRI)) scan) of the abdomen and pelvis along with a bone scan (x-rays of the bones) to see if the prostate cancer has moved to other parts of your body.
For this study, you will receive hormone injections to lower the levels of testosterone in the blood. You will also take imatinib mesylate capsules by mouth and receive treatment with docetaxel by vein to help kill the cancer cells before surgery.
You will receive hormone therapy with either leuprolide or goserelin acetate injections, whichever your doctor feels will give you the most benefit. The hormone injections will be given every other month or every 3 months. During treatment with the hormones, you will also take an anti-androgen drug called Casodex (bicalutamide) by mouth for up to 2 weeks. This drug is being used to help decrease the risks of developing side effects due to the hormone injections (this is the standard of care with hormone treatments). You will take imatinib mesylate capsules every day for 6 weeks starting with the hormone treatments. You will also receive treatment with docetaxel. Docetaxel injections are given by vein over 60 minutes once a week for 4 weeks in a row. This will be followed by 2 weeks with no docetaxel. This 6 week period is considered a course of treatment. You will have up to 3 courses of treatment (18 weeks) with docetaxel. After this treatment is complete, you will have prostate surgery within 4 weeks or when you have fully recovered from treatment.
During treatment, your general health will be monitored and you will have physical exams and blood tests (about 1-2 tablespoons) often to make sure that you are tolerating the treatment safely. If the disease gets worse or you experience intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
Before surgery, you will be given a general anesthetic. An incision (cut) will be made in your abdomen (lower stomach area) and your prostate gland and lymph nodes in the pelvis will be removed. Before the procedure, the risks will be explained to you and you will need to sign a separate consent form.
After surgery, you will have check-up visits every 3 months for 1 year, then every 6 months for the rest of your life. At these visits, you will have a physical exam and around 1-2 tablespoons of blood collected for routine lab tests. If your doctor feels it is necessary, you may also have CT scans, bone scans, and/or x-rays. These tests are being done to check if the cancer has come back. If the cancer comes back, you will be removed from the study and your doctor will discuss treatment options with you.
This is an investigational study. The leuprolide or goserelin acetate injections, bicalutamide tablets, imatinib mesylate capsules, and docetaxel injections are all FDA approved and are commercially available. Up to 36 participants will take part in this study. All will be enrolled at UT MD Anderson Cancer Center.
- Conditions
- Prostate Cancer
- Being tested
- Docetaxel, Imatinib Mesylate, Leuprolide, Goserelin Acetate
- Keywords
- Prostate Cancer, Hormonal Ablation, Docetaxel, Imatinib Mesylate, STI571, Gleevec, Taxotere, Goserelin Acetate, Zoladex, Leuprolide, Lupron
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
30 mg/m^2 by vein (IV) Weekly Over 60 Minutes on Days 1, 8, 15, and 22. This will be followed by 2 weeks with no docetaxel.
Imatinib MesylateDrug
Also called Gleevec, STI571
600 mg by mouth (PO) Daily x 42 Days.
LeuprolideDrug
Also called Lupron
Hormone injections given every other month or every 3 months, as determined by the doctor.
Goserelin AcetateDrug
Also called Zoladex
Hormone injections given every other month or every 3 months, as determined by the doctor.
| Study group | Role | What they receive |
|---|---|---|
| Hormonal Ablation, Imatinib + Docetaxel | Experimental | Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months Receives: Drug: Docetaxel; Drug: Imatinib Mesylate; Drug: Leuprolide; Drug: Goserelin Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Pathological Complete Response
Probability of response, defined as pathological complete remission based on tissue obtained at surgery. Pathological Complete Response (pCR): Patients without gross or microscopic evidence of residual disease at Radical Prostatectomy defined as pCR.
Measured: Every 3 months for 1 year, then every 6 months until disease progression or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startJun 2003
- Primary completionFeb 2010
- Study completionFeb 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Paul Mathew, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500110
- Sponsor's protocol ID
- ID03-0112
- Status last verified
- Aug 2012
- First submitted
- 10 Jul 2007
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mathew P, Pisters LL, Wood CG, Papadopoulos JN, Williams DL, Thall PF, Wen S, Horne E, Oborn CJ, Langley R, Fidler IJ, Pettaway CA. Neoadjuvant platelet derived growth factor receptor inhibitor therapy combined with docetaxel and androgen ablation for high risk localized prostate cancer. J Urol. 2009 Jan;181(1):81-7; discussion 87. doi: 10.1016/j.juro.2008.09.006. Epub 2008 Nov 13.
PubMed 19012911
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Hormonal Ablation, Imatinib Mesylate and Docetaxel Followed by Radical Prostatectomy for High-Risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00500110
- Acronym / sponsor ID
- ID03-0112
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Hormonal Ablation, Docetaxel, Imatinib Mesylate, STI571, Gleevec, Taxotere, Goserelin Acetate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jun 2003
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 12 Jul 2007 (estimated)
- Results
- Posted 4 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To evaluate the pathological complete response rate to neoadjuvant hormonal ablation, Imatinib and Docetaxel (HID) in high-risk localized prostate cancer.
Secondary Objectives:
- To describe the time to prostate specific antigen (PSA)-progression after neoadjuvant HID and radical prostatectomy in high-risk localized prostate cancer.
- To correlate pathological response with modulation of the Platelet-Derived Growth Factor Receptor (PDGFR) pathway.
Detailed description
Docetaxel is a drug that was designed to help kill cancer cells. Imatinib mesylate is a drug designed to block cancer cells from growing and dividing. Hormonal treatment with Lupron (leuprolide) or Zoladex (goserelin acetate) is used to lower testosterone levels in the body because prostate cancer cells need testosterone to survive. All patients will have their prostate gland removed after treatment with these drugs.
Before treatment starts, you will be asked questions about your medical history and have a complete physical examination. You will have blood drawn (2 tablespoons) for routine blood tests. You will be asked questions about any medications you are currently taking and have taken in the past. You will have an electrocardiogram (ECG - a test that measures electrical activity of the heart). As part of your standard care for prostate cancer, you will also have a computed tomography (CT) scan (or magnetic resonance imaging ((MRI)) scan) of the abdomen and pelvis along with a bone scan (x-rays of the bones) to see if the prostate cancer has moved to other parts of your body.
For this study, you will receive hormone injections to lower the levels of testosterone in the blood. You will also take imatinib mesylate capsules by mouth and receive treatment with docetaxel by vein to help kill the cancer cells before surgery.
You will receive hormone therapy with either leuprolide or goserelin acetate injections, whichever your doctor feels will give you the most benefit. The hormone injections will be given every other month or every 3 months. During treatment with the hormones, you will also take an anti-androgen drug called Casodex (bicalutamide) by mouth for up to 2 weeks. This drug is being used to help decrease the risks of developing side effects due to the hormone injections (this is the standard of care with hormone treatments). You will take imatinib mesylate capsules every day for 6 weeks starting with the hormone treatments. You will also receive treatment with docetaxel. Docetaxel injections are given by vein over 60 minutes once a week for 4 weeks in a row. This will be followed by 2 weeks with no docetaxel. This 6 week period is considered a course of treatment. You will have up to 3 courses of treatment (18 weeks) with docetaxel. After this treatment is complete, you will have prostate surgery within 4 weeks or when you have fully recovered from treatment.
During treatment, your general health will be monitored and you will have physical exams and blood tests (about 1-2 tablespoons) often to make sure that you are tolerating the treatment safely. If the disease gets worse or you experience intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
Before surgery, you will be given a general anesthetic. An incision (cut) will be made in your abdomen (lower stomach area) and your prostate gland and lymph nodes in the pelvis will be removed. Before the procedure, the risks will be explained to you and you will need to sign a separate consent form.
After surgery, you will have check-up visits every 3 months for 1 year, then every 6 months for the rest of your life. At these visits, you will have a physical exam and around 1-2 tablespoons of blood collected for routine lab tests. If your doctor feels it is necessary, you may also have CT scans, bone scans, and/or x-rays. These tests are being done to check if the cancer has come back. If the cancer comes back, you will be removed from the study and your doctor will discuss treatment options with you.
This is an investigational study. The leuprolide or goserelin acetate injections, bicalutamide tablets, imatinib mesylate capsules, and docetaxel injections are all FDA approved and are commercially available. Up to 36 participants will take part in this study. All will be enrolled at UT MD Anderson Cancer Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hormonal Ablation, Imatinib + Docetaxel | Experimental | Drug: Docetaxel, Drug: Imatinib Mesylate, Drug: Leuprolide, Drug: Goserelin AcetateImatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with adenocarcinoma of the prostate that in the opinion of the surgeon is resectable. Ductal adenocarcinoma of the prostate is included.
- All patients must be regarded as low anesthetic risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the neoadjuvant therapy.
- All patients must have at least one of the following high-risk features: clinical or pathological T3 disease, or cT2c or PSA>20ng/ml or Gleason 8-10 adenocarcinoma or clinical T2b and PSA>10ng/ml and Gleason 7 adenocarcinoma. The 1992 AJCC staging system will be followed.
- Prior hormonal therapy up to 2 months is permitted; no concurrent ketoconazole is permitted.
- Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,500/mm3 and platelet count of >/= 100,000/mm3; adequate hepatic function defined with a total bilirubin of </= 1.5 mg/dl and aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) </= 2 times the upper limits of normal; adequate renal function defined as serum creatinine clearance >/= 40 cc/min (measured or calculated).
Key exclusion criteria (9 listed)
- Patients with small cell or sarcomatoid prostate cancers are not eligible.
- Patients with clinical or radiological evidence of metastatic disease
- Prior chemotherapy or experimental agents
- Patients with severe intercurrent infection.
- Patients with The New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina or myocardial infarction (MI) in the last 6 months.
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 |
|---|---|---|
| DocetaxelAlso: Taxotere30 mg/m^2 by vein (IV) Weekly Over 60 Minutes on Days 1, 8, 15, and 22. This will be followed by 2 weeks with no docetaxel. | Drug | Hormonal Ablation, Imatinib + Docetaxel |
| Imatinib MesylateAlso: Gleevec, STI571600 mg by mouth (PO) Daily x 42 Days. | Drug | Hormonal Ablation, Imatinib + Docetaxel |
| LeuprolideAlso: LupronHormone injections given every other month or every 3 months, as determined by the doctor. | Drug | Hormonal Ablation, Imatinib + Docetaxel |
| Goserelin AcetateAlso: ZoladexHormone injections given every other month or every 3 months, as determined by the doctor. | Drug | Hormonal Ablation, Imatinib + Docetaxel |
Primary outcome
Number of Participants Achieving Pathological Complete Response
Time frame: Every 3 months for 1 year, then every 6 months until disease progression or death
Probability of response, defined as pathological complete remission based on tissue obtained at surgery. Pathological Complete Response (pCR): Patients without gross or microscopic evidence of residual disease at Radical Prostatectomy defined as pCR.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19012911Mathew P, Pisters LL, Wood CG, Papadopoulos JN, Williams DL, Thall PF, Wen S, Horne E, Oborn CJ, Langley R, Fidler IJ, Pettaway CA. Neoadjuvant platelet derived growth factor receptor inhibitor therapy combined with docetaxel and androgen ablation for high risk localized prostate cancer. J Urol. 2009 Jan;181(1):81-7; discussion 87. doi: 10.1016/j.juro.2008.09.006. Epub 2008 Nov 13.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
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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.
Paul Mathew, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Imatinib Mesylate and Leuprolide in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site 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 6 inclusion and 9 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 28 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 1 site 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 4 Aug 2011). 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?
Number of Participants Achieving Pathological Complete Response (time frame: Every 3 months for 1 year, then every 6 months until disease progression or death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00500110, which also lists 1 linked publication.
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 28 Apr 2015.