Prostate CancerPhase 22007-5904NCT00598858
Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate
A Phase 2 study testing Docetaxel and Prednisone in people with Prostate Cancer and Adenocarcinoma of the Prostate, run by John P. Fruehauf.
Trial summary
This pilot phase II trial studies docetaxel and prednisone in treating patients with newly diagnosed stage I-II prostate cancer undergoing prostatectomy. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Adenocarcinoma of the Prostate, Stage I Prostate Cancer
- What is being tested?
- Docetaxel and Prednisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Patient must have a histological diagnosis of adenocarcinoma of the prostate which is measurable or evaluable Stage I or II.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Patient must have a pre-study PSA within 28 days prior to start of therapy.
- Patients who have received prior radiotherapy are not eligible.
- Patient must have an adequate renal function
- Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- Age > 18
- Patients must be able to take oral medications
Who cannot join
- Patients with measurable metastatic diseases by a CT scan of the abdomen and pelvis within 28 days and by a bone scan within 42 days prior to start of therapy.
- Patient must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to start of therapy and must have recovered from toxicities of prior therapy to grade 1 or less with the exception of alopecia.
- Patients must not be treated with non-steroidal anti-androgens (flutamide, bicalutamide, nilutamide or ketoconazole).
- Patients must not take vitamins, herbs, or micronutrient supplement within 28 days prior to start of therapy.
- Patients may not have ongoing problems with bowel obstruction or short bowel syndrome characterized by grade 2 or greater diarrhea or malabsorptive disorders.
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
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- Patients should not have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up or compliance with the study protocol.
- Patients should not have any medical life-threatening complications of their malignancies
- Patients should not have a known severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, active uncontrolled infection, or HIV).
- Patients should not have current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
- Patients with history of myocardial infarction, cerebrovascular accident, transient ischemic attack, or unstable angina within 6 months
- Patients with clinically significant peripheral vascular disease
- Patients with evidence of bleeding diathesis or coagulopathy
- Patients with central nervous system or brain metastases
- Patients who had major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
- Patients with minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
- Patients with history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
- Patients with serious, non-healing wound, ulcer, or bone
- Patients who are diagnosed of any other malignancy except non-melanomatous skin cancer in the past 5 years
- Patients receiving anticoagulation therapy (e.g. Coumadin) prior to registration
About this study
Official title: Phase II Study to Determine the Effects of Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate in Patients Who Are Scheduled for Radical Prostatectomy With Genomic Correlates of Pathological Response
This pilot phase II trial studies docetaxel and prednisone in treating patients with newly diagnosed stage I-II prostate cancer undergoing prostatectomy. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as prednisone, may stimulate the immune system in different ways and stop cancer cells from growing. Giving docetaxel and prednisone together may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the rate of a 3-month prostate-specific antigen (PSA) decline of at least 30% by chemotherapy regimen of docetaxel and prednisone in patients with stage I/II prostate cancer, who are scheduled for prostatectomy.
II. To compare tumor, pathological and PSA responses to neoadjuvant docetaxel between patients with intermediate and high grades of prostate cancer.
III. To obtain prostate specimens for genomic correlates with responses of the chemotherapy regimen of docetaxel and prednisone.
OUTLINE:
Patients receive docetaxel intravenously (IV) over 60 minutes on days 1 and 2 and prednisone orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy within 3 weeks after completion of chemotherapy.
After completion of study treatment, patients are followed up within 7 days.
- Conditions
- Prostate Cancer, Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage II Prostate Cancer
- Being tested
- Docetaxel, Prednisone
- Keywords
- prostate cancer, 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.
DocetaxelDrug
Also called 114977-28-5, 40466, 628503, RP 56976
Given IV
PrednisoneDrug
Also called Adasone, Cortancyl, Dacortin, DeCortin
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (docetaxel and prednisone) | Experimental | Patients receive docetaxel IV over 60 minutes on days 1 and 2 and prednisone PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Docetaxel; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA response rate (partial response (PR) + complete response (CR))
Expressed with two-sided exact binomial confidence intervals. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. The difference of response rates between different pre-treatment pathological stages or Gleason scores will also be examined by Fisher's exact test. Associations between PSA response and tumor response, and PSA response and gene expression will also be examined by Fisher's exact test.
Measured: 9 weeks
Secondary outcomes (4)
Rates of tumor response
Expressed with two-sided exact binomial confidence intervals.
Measured: Up to 7 days after completion of study treatment
The rate of negative surgical margin
Measured: Up to 7 days after completion of study treatment
The proportion of patients with pathological down-staging defined as evidence of decreased pathological stage or Gleason score when compared with pretreatment pathological stage
Measured: Up to 7 days after completion of study treatment
Adverse events defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment
Severity will be categorized by toxicity grade according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: Up to 28 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startJan 2009
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Halted due to zero accrual and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- John P. Fruehauf
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor-investigator, John P. Fruehauf, University of California, Irvine
- Investigators
- John P. Fruehauf, MD, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598858
- Sponsor's protocol ID
- UCI 07-14
- Other IDs
- 2007-5904, NCI-2012-02085
- Acronym
- 2007-5904
- Status last verified
- Apr 2013
- First submitted
- 10 Jan 2008
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Determine the Effects of Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate in Patients Who Are Scheduled for Radical Prostatectomy With Genomic Correlates of Pathological Response
- ClinicalTrials.gov ID
- NCT00598858
- Acronym / sponsor ID
- 2007-5904 / UCI 07-14
- Conditions
- Prostate Cancer, Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage II Prostate Cancer
- Keywords
- prostate cancer, Prostatectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Halted due to zero accrual and lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- John P. FruehaufUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jan 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 23 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot phase II trial studies docetaxel and prednisone in treating patients with newly diagnosed stage I-II prostate cancer undergoing prostatectomy. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as prednisone, may stimulate the immune system in different ways and stop cancer cells from growing. Giving docetaxel and prednisone together may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- To determine the rate of a 3-month prostate-specific antigen (PSA) decline of at least 30% by chemotherapy regimen of docetaxel and prednisone in patients with stage I/II prostate cancer, who are scheduled for prostatectomy.
II. To compare tumor, pathological and PSA responses to neoadjuvant docetaxel between patients with intermediate and high grades of prostate cancer.
III. To obtain prostate specimens for genomic correlates with responses of the chemotherapy regimen of docetaxel and prednisone.
OUTLINE:
Patients receive docetaxel intravenously (IV) over 60 minutes on days 1 and 2 and prednisone orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy within 3 weeks after completion of chemotherapy.
After completion of study treatment, patients are followed up within 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (docetaxel and prednisone) | Experimental | Drug: Docetaxel, Drug: PrednisonePatients receive docetaxel IV over 60 minutes on days 1 and 2 and prednisone PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
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)
- Patient must have a histological diagnosis of adenocarcinoma of the prostate which is measurable or evaluable Stage I or II.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Patient must have a pre-study PSA within 28 days prior to start of therapy.
- Patients who have received prior radiotherapy are not eligible.
- Patient must have an adequate renal function
Key exclusion criteria (20 listed)
- Patients with measurable metastatic diseases by a CT scan of the abdomen and pelvis within 28 days and by a bone scan within 42 days prior to start of therapy.
- Patient must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to start of therapy and must have recovered from toxicities of prior therapy to grade 1 or less with the exception of alopecia.
- Patients must not be treated with non-steroidal anti-androgens (flutamide, bicalutamide, nilutamide or ketoconazole).
- Patients must not take vitamins, herbs, or micronutrient supplement within 28 days prior to start of therapy.
- Patients may not have ongoing problems with bowel obstruction or short bowel syndrome characterized by grade 2 or greater diarrhea or malabsorptive disorders.
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: 114977-28-5, 40466, 628503, RP 56976Given IV | Drug | Treatment (docetaxel and prednisone) |
| PrednisoneAlso: Adasone, Cortancyl, Dacortin, DeCortinGiven PO | Drug | Treatment (docetaxel and prednisone) |
Primary outcome
PSA response rate (partial response (PR) + complete response (CR))
Time frame: 9 weeks
Expressed with two-sided exact binomial confidence intervals. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. The difference of response rates between different pre-treatment pathological stages or Gleason scores will also be examined by Fisher's exact test. Associations between PSA response and tumor response, and PSA response and gene expression will also be examined by Fisher's exact test.
4 secondary outcomes
Rates of tumor response
Time frame: Up to 7 days after completion of study treatment
The rate of negative surgical margin
Time frame: Up to 7 days after completion of study treatment
The proportion of patients with pathological down-staging defined as evidence of decreased pathological stage or Gleason score when compared with pretreatment pathological stage
Time frame: Up to 7 days after completion of study treatment
Adverse events defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment
Time frame: Up to 28 days after completion of study treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
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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.
John P. Fruehauf, MD, PhD principal investigator
University of California, Irvine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Prednisone in people with Prostate Cancer and Adenocarcinoma of the Prostate, run by John P. Fruehauf.
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 20 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: withdrawn, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 rate (partial response (PR) + complete response (CR)) (time frame: 9 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 8 Dec 2016.