Prostate CancerPhase 2NCT00299741
Study of SU11248 in Men With Advanced Prostate Cancer
A Phase 2 study testing Sunitinib in people with Prostate Cancer, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new cancer treatments. SU011248 is an exciting, new, experimental drug that inhibits a number of proteins, or more specifically receptor tyrosine kinases, in tumor cells. 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?
- Sunitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2006to Jun 2008
- 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
- Signed informed consent indicating that the subject has been informed of all pertinent aspects of the trial.
- Adenocarcinoma of the prostate
- Male subjects, 18 years of age or older
- Life expectancy of > 12 weeks
- Resolution of all acute toxic effects of prior chemotherapy, radiotherapy or surgical procedure to National Cancer Institute Common Toxicity Criteria Adverse Event (NCI CTCAE) grade <1
- Surgical or ongoing chemical castration
Show all 23Show fewer
- Androgen-independent disease, defined as progressive disease despite surgical or ongoing chemical castration. See section 8.2.3 for definition of progressive disease.
- Eastern Cooperative Oncology Group performance status of 0, 1 or 2
- Adequate bone marrow reserve:
- Neutrophil count > 1,500/ul
- Platelet count > 75,000/ul
- Adequate hepatic function:
- Serum bilirubin < 1.5 x upper limit of normal
- Asparate aminotransferase and alanine aminotransferase < 2.5 x upper limit of normal
- Adequate renal function, with serum creatinine < 2 x upper limit of normal
- Prostate Specific Antigen (PSA) > 5.0 ng/mL, based on PSA Working Group Criteria
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
- For Group A only:
- No prior treatment for prostate cancer with cytotoxic chemotherapy
- For Group B only:
- Radiographic evidence of metastatic prostate cancer
- One prior docetaxel-based chemotherapy regimen, minimum of two cycles
- Disease progression during treatment with docetaxel, or within 60 days of receiving docetaxel
Who cannot join
- Small cell carcinoma of the prostate
- Treatment with extensive external beam radiation therapy or radionuclide therapy within six weeks of study entry. Palliative radiation involving less than 20% of bone marrow reserves must have been completed within four weeks of entry.
- Any of the following within the prior 6 months: unstable angina, myocardial infarction, symptomatic congestive heart failure or cerebrovascular accident
- Receipt of any investigational anti-cancer agent within 4 weeks of the study
- NCI CTCAE grade 3 hemorrhage < 4 weeks of starting study treatment
- Uncontrolled hypertension
- Prolongation of the QTc interval to > 450 msec
- Other serious acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel-Deaconess Medical Center
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Study of SU011248 in Men With Advanced Prostate Cancer
- There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new cancer treatments.
- SU011248 is an exciting, new, experimental drug that inhibits a number of proteins, or more specifically receptor tyrosine kinases, in tumor cells. These proteins are active in cellular pathways that are important for development and growth of a variety of different cancers. The targets of SU011248 include the receptors for vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and others. By blocking the VEGF and PDGF pathways, SU011248 can induce death of the blood vessels that nourish the cancer cells and death of the cancer cells themselves.
- SU011248 has demonstrated significant anti-tumor activity in renal cell carcinoma, gastrointestinal stromal tumors, and other cancers. Its effect against prostate cancer has not been studied to date.
- This study is directed at two populations of men with advanced prostate cancer:
- Men with advanced prostate cancer who have a rising PSA despite hormone therapy, but have not yet received any chemotherapy.
- Men with metastatic prostate cancer who have received prior chemotherapy (with a docetaxel-based regimen) and have increasing disease following chemotherapy.
Read more
- Men in this study will receive SU011248 on a six-week repeating schedule, with four weeks of daily treatment followed by a two-week rest. The goals of the study are:
- to determine whether SU011248 is an important therapeutic agent in men with advanced prostate cancer, and
- to identify predictive markers of anti-cancer activity within individual subjects that would allow selective treatment of appropriate subjects in the future.
Read the detailed description
Background: There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new therapeutics. The mainstay of therapy for advanced prostate cancer is androgen deprivation therapy (ADT). Although ADT is effective in the large majority of men with advanced prostate cancer, the favorable response to ADT is only transient. In hormone-refractory, metastatic prostate cancer the only effective systemic treatment is cytotoxic chemotherapy. The median duration of response to standard, taxane-based chemotherapy is approximately six months, and median survival in contemporary studies is only 16-18 months. Thus, there is an urgent need for new therapeutic agents to treat advanced prostate cancer.
SU011248 is an orally administered inhibitor of the vascular endothelial growth factor (VEGF) receptors, platelet-derived growth factor (PDGF) receptor, FLT-3 and c-KIT. SU011248 has demonstrated significant clinical activity in other malignancies, but its activity in prostate cancer has not been studied to date. Clinical trials have demonstrated that SU011248 is generally well tolerated, with mild fatigue and diarrhea the most common adverse effects. Preclinical studies have demonstrated that levels of VEGF and PDGF are elevated in prostate cancer and may correlate with worse outcome. The inhibition of several pathways implicated in prostate cancer progression by SU011248 suggests that it might have significant anti-tumor activity in men with AIPC.
Many of the new, targeted agents are efficacious in only a subset of patients with a particular malignancy, and these subsets may be definable on the basis of specific tumor mutations or patterns of gene expression. Identification of reliable predictive methods is crucial in moving forward with targeted therapies, and we believe that exploratory clinical trials such as this one should incorporate assays designed to address this issue.
Objective/Hypothesis: The objective of this proposal is to determine whether SU011248 is an effective treatment in two cohorts of men with advanced prostate cancer: men with androgen-independent prostate cancer (AIPC) who have not been treated with chemotherapy (Group A), and men with taxane-refractory, metastatic disease (Group B). We hypothesize that specific serum biomarkers and tumor mutations may predict response and may allow optimal subject selection in the future.
Specific Aims: (1) To evaluate the efficacy and safety of SU011248 in men with chemo-naïve AIPC, (2) to evaluate the efficacy and safety of SU011248 in men with metastatic, taxane-resistant AIPC, (3) to measure serum biomarkers in men with AIPC prior to and following treatment with SU011248 and correlate these markers with clinical response, and (4) to mutational analysis from tumor specimens of men with metastatic prostate cancer treated with SU011248 and correlate with clinical response.
Study Design: We will conduct a phase II clinical trial in two groups of subjects: men with AIPC who have not yet developed overt metastases (Group A), and men with taxane-refractory, metastatic disease (Group B). Men in both groups will receive single-agent SU011248 on a six-week repeating schedule, with four weeks of daily treatment followed by a two-week rest. The primary endpoint will be PSA response rate. Secondary endpoints will include time to disease progression, objective response rate, and safety parameters. Eligibility for this study will require signed informed consent, adenocarcinoma of the prostate, documented PSA progression despite ADT, reasonable functional status, resolution of toxic effects from prior treatments, and acceptable bone marrow, hepatic, renal and cardiac function. A Simon's two-stage design will be employed to allow early termination for lack of efficacy. Ultimately, 30 patients will be enrolled in each group, for a total of 60 patients. A defined program of history and physical examinations, radiographic studies, and laboratory tests including PSA will be carried out to determine the efficacy and safety of SU011248 in this patient population.
All subjects will have blood and urine collected for research purposes, and men in Group B will have tumor biopsy prior to enrollment. Translational studies aimed at identifying specific biomarkers in the blood will include analysis of serum cytokine levels including VEGF and others, circulating endothelial cells and endothelial precursors, white blood cell differential, and bone turnover markers. Tumor samples will be analyzed for the presence of predictive tumor mutations.
Relevance: Our ultimate goals are to determine whether SU011248 is an important therapeutic agent in men with advanced prostate cancer, and to identify predictive markers of anti-cancer activity within individual subjects that would allow selective treatment of appropriate subjects in the future. The data obtained should also contribute to our general understanding of serum biomarkers and genetic changes in advanced prostate cancer. Positive results of our trial would lead to expanded, multi-center trials of SU011248 in men with advanced prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Sunitinib
- Keywords
- Sutent, Sunitinib, Bone, Metastatic, Hormone-refractory, Biomarkers
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Also called Sutent
Sunitinib 50 mg daily, 4/2 schedule
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sunitinib Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Men With Advanced Prostate Cancer Treated With Sunitinib Who Have a Prostate Specific Antigen (PSA) Response
Prostate specific antigen (PSA) responses, defined as the number of men who exhibit PSA decline of at least 50% that is confirmed by a second PSA value 4 or more weeks later (PSA Working Group I Criteria)
Measured: were followed until disease progression, an average of 12 weeks
Secondary outcomes (1)
Objective Responses, Defined as the Number of Participants With Complete or Partial Response
The response rate is defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions as assessed by radiographic evaluation. Complete response(CR): disappearance of all target lesions; Partial response(PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall response = CR + PR.
Measured: Participants were followed until the time of disease progression, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionJun 2008
- Study completionJun 2008
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 (2)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 Massachusetts General HospitalThe 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Dror Michaelson, MD, Massachusetts General Hospital
- Investigators
- Dror Michaelson, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299741
- Sponsor's protocol ID
- W81XWH-05-1-0439
- Status last verified
- Dec 2012
- First submitted
- 3 Mar 2006
- Last updated
- 19 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dror Michaelson M, Regan MM, Oh WK, Kaufman DS, Olivier K, Michaelson SZ, Spicer B, Gurski C, Kantoff PW, Smith MR. Phase II study of sunitinib in men with advanced prostate cancer. Ann Oncol. 2009 May;20(5):913-20. doi: 10.1093/annonc/mdp111.
PubMed 19403935Saylor PJ, Mahmood U, Kunawudhi A, Smith MR, Palmer EL, Michaelson MD. Multitargeted tyrosine kinase inhibition produces discordant changes between 99mTc-MDP bone scans and other disease biomarkers: analysis of a phase II study of sunitinib for metastatic castration-resistant prostate cancer. J Nucl Med. 2012 Nov;53(11):1670-5. doi: 10.2967/jnumed.112.105007. Epub 2012 Sep 14.
PubMed 22984218
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of SU011248 in Men With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT00299741
- Acronym / sponsor ID
- W81XWH-05-1-0439
- Conditions
- Prostate Cancer
- Keywords
- Sutent, Sunitinib, Bone, Metastatic, Hormone-refractory, Biomarkers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Mar 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 Mar 2006 (estimated)
- Results
- Posted 13 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new cancer treatments.
- SU011248 is an exciting, new, experimental drug that inhibits a number of proteins, or more specifically receptor tyrosine kinases, in tumor cells. These proteins are active in cellular pathways that are important for development and growth of a variety of different cancers. The targets of SU011248 include the receptors for vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and others. By blocking the VEGF and PDGF pathways, SU011248 can induce death of the blood vessels that nourish the cancer cells and death of the cancer cells themselves.
- SU011248 has demonstrated significant anti-tumor activity in renal cell carcinoma, gastrointestinal stromal tumors, and other cancers. Its effect against prostate cancer has not been studied to date.
- This study is directed at two populations of men with advanced prostate cancer:
- Men with advanced prostate cancer who have a rising PSA despite hormone therapy, but have not yet received any chemotherapy.
- Men with metastatic prostate cancer who have received prior chemotherapy (with a docetaxel-based regimen) and have increasing disease following chemotherapy.
- Men in this study will receive SU011248 on a six-week repeating schedule, with four weeks of daily treatment followed by a two-week rest. The goals of the study are:
- to determine whether SU011248 is an important therapeutic agent in men with advanced prostate cancer, and
- to identify predictive markers of anti-cancer activity within individual subjects that would allow selective treatment of appropriate subjects in the future.
Detailed description
Background: There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new therapeutics. The mainstay of therapy for advanced prostate cancer is androgen deprivation therapy (ADT). Although ADT is effective in the large majority of men with advanced prostate cancer, the favorable response to ADT is only transient. In hormone-refractory, metastatic prostate cancer the only effective systemic treatment is cytotoxic chemotherapy. The median duration of response to standard, taxane-based chemotherapy is approximately six months, and median survival in contemporary studies is only 16-18 months. Thus, there is an urgent need for new therapeutic agents to treat advanced prostate cancer.
SU011248 is an orally administered inhibitor of the vascular endothelial growth factor (VEGF) receptors, platelet-derived growth factor (PDGF) receptor, FLT-3 and c-KIT. SU011248 has demonstrated significant clinical activity in other malignancies, but its activity in prostate cancer has not been studied to date. Clinical trials have demonstrated that SU011248 is generally well tolerated, with mild fatigue and diarrhea the most common adverse effects. Preclinical studies have demonstrated that levels of VEGF and PDGF are elevated in prostate cancer and may correlate with worse outcome. The inhibition of several pathways implicated in prostate cancer progression by SU011248 suggests that it might have significant anti-tumor activity in men with AIPC.
Many of the new, targeted agents are efficacious in only a subset of patients with a particular malignancy, and these subsets may be definable on the basis of specific tumor mutations or patterns of gene expression. Identification of reliable predictive methods is crucial in moving forward with targeted therapies, and we believe that exploratory clinical trials such as this one should incorporate assays designed to address this issue.
Objective/Hypothesis: The objective of this proposal is to determine whether SU011248 is an effective treatment in two cohorts of men with advanced prostate cancer: men with androgen-independent prostate cancer (AIPC) who have not been treated with chemotherapy (Group A), and men with taxane-refractory, metastatic disease (Group B). We hypothesize that specific serum biomarkers and tumor mutations may predict response and may allow optimal subject selection in the future.
Specific Aims: (1) To evaluate the efficacy and safety of SU011248 in men with chemo-naïve AIPC, (2) to evaluate the efficacy and safety of SU011248 in men with metastatic, taxane-resistant AIPC, (3) to measure serum biomarkers in men with AIPC prior to and following treatment with SU011248 and correlate these markers with clinical response, and (4) to mutational analysis from tumor specimens of men with metastatic prostate cancer treated with SU011248 and correlate with clinical response.
Study Design: We will conduct a phase II clinical trial in two groups of subjects: men with AIPC who have not yet developed overt metastases (Group A), and men with taxane-refractory, metastatic disease (Group B). Men in both groups will receive single-agent SU011248 on a six-week repeating schedule, with four weeks of daily treatment followed by a two-week rest. The primary endpoint will be PSA response rate. Secondary endpoints will include time to disease progression, objective response rate, and safety parameters. Eligibility for this study will require signed informed consent, adenocarcinoma of the prostate, documented PSA progression despite ADT, reasonable functional status, resolution of toxic effects from prior treatments, and acceptable bone marrow, hepatic, renal and cardiac function. A Simon's two-stage design will be employed to allow early termination for lack of efficacy. Ultimately, 30 patients will be enrolled in each group, for a total of 60 patients. A defined program of history and physical examinations, radiographic studies, and laboratory tests including PSA will be carried out to determine the efficacy and safety of SU011248 in this patient population.
All subjects will have blood and urine collected for research purposes, and men in Group B will have tumor biopsy prior to enrollment. Translational studies aimed at identifying specific biomarkers in the blood will include analysis of serum cytokine levels including VEGF and others, circulating endothelial cells and endothelial precursors, white blood cell differential, and bone turnover markers. Tumor samples will be analyzed for the presence of predictive tumor mutations.
Relevance: Our ultimate goals are to determine whether SU011248 is an important therapeutic agent in men with advanced prostate cancer, and to identify predictive markers of anti-cancer activity within individual subjects that would allow selective treatment of appropriate subjects in the future. The data obtained should also contribute to our general understanding of serum biomarkers and genetic changes in advanced prostate cancer. Positive results of our trial would lead to expanded, multi-center trials of SU011248 in men with advanced prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SunitinibSunitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Signed informed consent indicating that the subject has been informed of all pertinent aspects of the trial.
- Adenocarcinoma of the prostate
- Male subjects, 18 years of age or older
- Life expectancy of > 12 weeks
- Resolution of all acute toxic effects of prior chemotherapy, radiotherapy or surgical procedure to National Cancer Institute Common Toxicity Criteria Adverse Event (NCI CTCAE) grade <1
Key exclusion criteria (8 listed)
- Small cell carcinoma of the prostate
- Treatment with extensive external beam radiation therapy or radionuclide therapy within six weeks of study entry. Palliative radiation involving less than 20% of bone marrow reserves must have been completed within four weeks of entry.
- Any of the following within the prior 6 months: unstable angina, myocardial infarction, symptomatic congestive heart failure or cerebrovascular accident
- Receipt of any investigational anti-cancer agent within 4 weeks of the study
- NCI CTCAE grade 3 hemorrhage < 4 weeks of starting study treatment
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 |
|---|---|---|
| SunitinibAlso: SutentSunitinib 50 mg daily, 4/2 schedule | Drug | 1 |
Primary outcome
The Number of Men With Advanced Prostate Cancer Treated With Sunitinib Who Have a Prostate Specific Antigen (PSA) Response
Time frame: were followed until disease progression, an average of 12 weeks
Prostate specific antigen (PSA) responses, defined as the number of men who exhibit PSA decline of at least 50% that is confirmed by a second PSA value 4 or more weeks later (PSA Working Group I Criteria)
1 secondary outcome
Objective Responses, Defined as the Number of Participants With Complete or Partial Response
Time frame: Participants were followed until the time of disease progression, an average of 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19403935Dror Michaelson M, Regan MM, Oh WK, Kaufman DS, Olivier K, Michaelson SZ, Spicer B, Gurski C, Kantoff PW, Smith MR. Phase II study of sunitinib in men with advanced prostate cancer. Ann Oncol. 2009 May;20(5):913-20. doi: 10.1093/annonc/mdp111.
- Derived from this study: PubMed 22984218Saylor PJ, Mahmood U, Kunawudhi A, Smith MR, Palmer EL, Michaelson MD. Multitargeted tyrosine kinase inhibition produces discordant changes between 99mTc-MDP bone scans and other disease biomarkers: analysis of a phase II study of sunitinib for metastatic castration-resistant prostate cancer. J Nucl Med. 2012 Nov;53(11):1670-5. doi: 10.2967/jnumed.112.105007. Epub 2012 Sep 14.
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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.
Dror Michaelson, MD PhD principal investigator
Massachusetts General Hospital
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 Sunitinib in people with Prostate Cancer, run by Massachusetts General Hospital 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 23 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 19 Dec 2012. 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. 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 13 Dec 2012). 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?
The Number of Men With Advanced Prostate Cancer Treated With Sunitinib Who Have a Prostate Specific Antigen (PSA) Response (time frame: were followed until disease progression, an average of 12 weeks). 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 NCT00299741, which also lists 2 linked publications.
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 19 Dec 2012; AzTrials last refreshed its copy on 7 Nov 2026.