Prostate CancerPhase 1NCT00790595
Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy
A Phase 1 study testing SU011248 in people with Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
Prostate cancer is prevalent in the United States, with approximately 230,110 new cases and 29,900 deaths in 2004. Approximately 30% of new cases will be clinical stage T3 when they are diagnosed. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- SU011248
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jul 2009
- Phase
- Phase 1
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate glad.
- Informed of, willing, and able to comply with, the requirements of the investigational study and have signed a written informed consent in accordance with institutional regulatory guidelines.
- Subjects defined as being at high risk for disease relapse based on the following criteria: PSA > 10 ng/ml, and any one of the following: Gleason > 7 or T stage > T2b.
- Patients must have elected to and are a candidate to undergo a radical prostatectomy.
- Males greater than 18 years of age and less than or equal to 75 years of age (physiologic) any racial/ethnic group.
- Free of significant abnormal findings as determined by screening history, physical exam, vital signs (blood pressure, heart rate, respiration rate, and temperature), and urinalysis.
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- Performance status: ECOG < 2.
- Life expectancy of at least 5 years.
- Absolute granulocyte count > 1,500/mm3.
- Platelet count > 100,000.
- Hemoglobin > 9.0 g/dL.
- Serum calcium < 12.0 mg/dL Adequate hepatic function as evidenced by ALT and AST values within normal range. Adequate organ function as defined by the following criteria: Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) < 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT < 5 x ULN if liver function abnormalities are due to underlying malignancy.
- Creatinine < 1.5 ULN.
Who cannot join
- Patients who have stage T2a or less prostate cancer, Gleason < 6, PSA <10-ng/mL.
- Prior hormonal, surgical, radiopharmaceutical or radiation therapy, cryotherapy, biological response modifiers, or systematic chemotherapy to treat prostatic carcinoma.
- Surgery within four weeks of study entry.
- Evidence of regional and/or distant metastases.
- Use of an investigational drug within 30 days prior to study entry.
- NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment.
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- Any of the following thing the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade > 2.
- Prolonged QTc interval on baseline EKG.
- Uncontrolled Hypertension (>150/100 mm Hg despite optimal medical therapy).
- Patients receiving CYP3A4 inducers or inhibitors; patients should not take grapefruit juice or St. John's Wort while on the study
- Known active infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles, Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Phase I, Open Label, Single Center, Multiple Dose, Dose Escalation Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy
Prostate cancer is prevalent in the United States, with approximately 230,110 new cases and 29,900 deaths in 2004. Approximately 30% of new cases will be clinical stage T3 when they are diagnosed. This is a stage in which there is high probability that the cancer has spread beyond the prostate gland itself, making it much more difficult to treat. In these cases, when surgery is done by itself and the prostate is removed, it is still very likely that some cancer that has spread beyond the prostate remains and will get worse. Radiation applied to the prostate also does not work well on tumors that have spread beyond the prostate. Even surgery and radiation combined have not eliminated the problems caused by prostate cancer that has spread into the tissue outside the prostate itself.
New treatments are needed to deal with prostate cancer at this more serious stage. Study doctors believe that it might be possible to shrink the prostate cancer using a new drug called SUO11248 or Sunitinib. After the patients take the drug, study doctors believe the cancer will shrink back to within the prostate, and they can then surgically remove the prostate and all the cancer. Patients on this study also will be given increasing doses of Sunitinib to find out how much of the drug can be given safely.
- Conditions
- Prostate Cancer
- Being tested
- SU011248
- Keywords
- 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.
SU011248Drug
5 Subjects will receive 50.0 mg/d of the study drug for 2 weeks.
SU011248Drug
5 Subjects will receive 50.0 mg/d of the study drug for 4 weeks.
SU011248Drug
5 Subjects will receive 50.0 mg/d of the study drug for 1 week.
SU011248Drug
5 Subjects will receive 37.5 mg/d of the study drug for 1 week.
SU011248Drug
5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 5 Subjects will receive 37.5 mg/d of the study drug for 1 week. Receives: Drug: SU011248 |
| Group B | Experimental | 5 Subjects will receive 50.0 mg/d of the study drug for 1 week. Receives: Drug: SU011248 |
| Group C | Experimental | 5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks. Receives: Drug: SU011248 |
| Group D | Experimental | 5 Subjects will receive 50.0 mg/d of the study drug for 2 weeks. Receives: Drug: SU011248 |
| Group E | Experimental | 5 Subjects will receive 50.0 mg/d of the study drug for 4 weeks. Receives: Drug: SU011248 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of SU011248 by histological examination of prostate tumors following radical prostatectomy.
Measured: 24 months
To determine maximum tolerable dose of SU011248 when administered with prostate cancer prior to radical prostatectomy.
Measured: 4 weeks
Secondary outcomes (1)
To evaluate the effects of SUO11248 on tumoral phospho VEGF/PDGF, receptor TK pathways, microvessel density, antiangiogenic activities and serum PSA levels.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startJun 2006
- Primary completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)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 Jonsson Comprehensive 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Arie Belldegrun, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790595
- Sponsor's protocol ID
- 06-03-129
- Other IDs
- Pfizer2005-0958
- Status last verified
- Jul 2012
- First submitted
- 12 Nov 2008
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weir HK, Thun MJ, Hankey BF, Ries LA, Howe HL, Wingo PA, Jemal A, Ward E, Anderson RN, Edwards BK. Annual report to the nation on the status of cancer, 1975-2000, featuring the uses of surveillance data for cancer prevention and control. J Natl Cancer Inst. 2003 Sep 3;95(17):1276-99. doi: 10.1093/jnci/djg040.
PubMed 12953083Cancer Facts and Figures 2004. American Cancer Society, 2004.
Pound CR, Partin AW, Eisenberger MA, Chan DW, Pearson JD, Walsh PC. Natural history of progression after PSA elevation following radical prostatectomy. JAMA. 1999 May 5;281(17):1591-7. doi: 10.1001/jama.281.17.1591.
PubMed 10235151Roehl KA, Han M, Ramos CG, Antenor JA, Catalona WJ. Cancer progression and survival rates following anatomical radical retropubic prostatectomy in 3,478 consecutive patients: long-term results. J Urol. 2004 Sep;172(3):910-4. doi: 10.1097/01.ju.0000134888.22332.bb.
PubMed 15310996Kasamon KM, Dawson NA. Update on hormone-refractory prostate cancer. Curr Opin Urol. 2004 May;14(3):185-93. doi: 10.1097/00042307-200405000-00008.
PubMed 15069310Zagars GK. Prostate-specific antigen as a prognostic factor for prostate cancer treated by external beam radiotherapy. Int J Radiat Oncol Biol Phys. 1992;23(1):47-53. doi: 10.1016/0360-3016(92)90542-p.
PubMed 1374065Stamey TA, Kabalin JN, Ferrari M. Prostate specific antigen in the diagnosis and treatment of adenocarcinoma of the prostate. III. Radiation treated patients. J Urol. 1989 May;141(5):1084-7. doi: 10.1016/s0022-5347(17)41176-1.
PubMed 2468796Kabalin JN, Hodge KK, McNeal JE, Freiha FS, Stamey TA. Identification of residual cancer in the prostate following radiation therapy: role of transrectal ultrasound guided biopsy and prostate specific antigen. J Urol. 1989 Aug;142(2 Pt 1):326-31. doi: 10.1016/s0022-5347(17)38746-3.
PubMed 2473221Zagars GK, von Eschenbach AC, Johnson DE, Oswald MJ. Stage C adenocarcinoma of the prostate. An analysis of 551 patients treated with external beam radiation. Cancer. 1987 Oct 1;60(7):1489-99. doi: 10.1002/1097-0142(19871001)60:73.0.co;2-9.
PubMed 3113715Bagshaw MA, Cox RS, Ramback JE. Radiation therapy for localized prostate cancer. Justification by long-term follow-up. Urol Clin North Am. 1990 Nov;17(4):787-802.
PubMed 2219577Wheeler JA, Zagars GK, Ayala AG. Dedifferentiation of locally recurrent prostate cancer after radiation therapy. Evidence for tumor progression. Cancer. 1993 Jun 1;71(11):3783-7. doi: 10.1002/1097-0142(19930601)71:113.0.co;2-x.
PubMed 8490929Cumming JA, Ritchie AW, Goodman CM, McIntyre MA, Chisholm GD. De-differentiation with time in prostate cancer and the influence of treatment on the course of the disease. Br J Urol. 1990 Mar;65(3):271-4. doi: 10.1111/j.1464-410x.1990.tb14725.x.
PubMed 2337747Stamey TA and McNeal JE: Adenocarcinoma of the prostate. In Campbell's Urology 6th edition (Walsh PC, Retik AB, Stamey MA and Vaughan ED, eds), W.B. Saunders Co., pp 1159-1221, 1992.
Stamey TA, Villers AA, McNeal JE, Link PC, Freiha FS. Positive surgical margins at radical prostatectomy: importance of the apical dissection. J Urol. 1990 Jun;143(6):1166-72; discussion 1172-3. doi: 10.1016/s0022-5347(17)40216-3.
PubMed 2342177Rosen MA, Goldstone L, Lapin S, Wheeler T, Scardino PT. Frequency and location of extracapsular extension and positive surgical margins in radical prostatectomy specimens. J Urol. 1992 Aug;148(2 Pt 1):331-7. doi: 10.1016/s0022-5347(17)36587-4.
PubMed 1635129
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open Label, Single Center, Multiple Dose, Dose Escalation Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT00790595
- Acronym / sponsor ID
- 06-03-129
- Conditions
- Prostate Cancer
- Keywords
- Prostatectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2006
- Primary completion
- Jul 2009 (actual)
- First posted
- 13 Nov 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.
Prostate cancer is prevalent in the United States, with approximately 230,110 new cases and 29,900 deaths in 2004. Approximately 30% of new cases will be clinical stage T3 when they are diagnosed. This is a stage in which there is high probability that the cancer has spread beyond the prostate gland itself, making it much more difficult to treat. In these cases, when surgery is done by itself and the prostate is removed, it is still very likely that some cancer that has spread beyond the prostate remains and will get worse. Radiation applied to the prostate also does not work well on tumors that have spread beyond the prostate. Even surgery and radiation combined have not eliminated the problems caused by prostate cancer that has spread into the tissue outside the prostate itself.
New treatments are needed to deal with prostate cancer at this more serious stage. Study doctors believe that it might be possible to shrink the prostate cancer using a new drug called SUO11248 or Sunitinib. After the patients take the drug, study doctors believe the cancer will shrink back to within the prostate, and they can then surgically remove the prostate and all the cancer. Patients on this study also will be given increasing doses of Sunitinib to find out how much of the drug can be given safely.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: SU0112485 Subjects will receive 37.5 mg/d of the study drug for 1 week. |
| Group B | Experimental | Drug: SU0112485 Subjects will receive 50.0 mg/d of the study drug for 1 week. |
| Group C | Experimental | Drug: SU0112485 Subjects will receive 37.5 mg/d of the study drug for 2 weeks. |
| Group D | Experimental | Drug: SU0112485 Subjects will receive 50.0 mg/d of the study drug for 2 weeks. |
| Group E | Experimental | Drug: SU0112485 Subjects will receive 50.0 mg/d of the study drug for 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed adenocarcinoma of the prostate glad.
- Informed of, willing, and able to comply with, the requirements of the investigational study and have signed a written informed consent in accordance with institutional regulatory guidelines.
- Subjects defined as being at high risk for disease relapse based on the following criteria: PSA > 10 ng/ml, and any one of the following: Gleason > 7 or T stage > T2b.
- Patients must have elected to and are a candidate to undergo a radical prostatectomy.
- Males greater than 18 years of age and less than or equal to 75 years of age (physiologic) any racial/ethnic group.
Key exclusion criteria (12 listed)
- Patients who have stage T2a or less prostate cancer, Gleason < 6, PSA <10-ng/mL.
- Prior hormonal, surgical, radiopharmaceutical or radiation therapy, cryotherapy, biological response modifiers, or systematic chemotherapy to treat prostatic carcinoma.
- Surgery within four weeks of study entry.
- Evidence of regional and/or distant metastases.
- Use of an investigational drug within 30 days prior to study entry.
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 |
|---|---|---|
| SU0112485 Subjects will receive 50.0 mg/d of the study drug for 2 weeks. | Drug | Group D |
| SU0112485 Subjects will receive 50.0 mg/d of the study drug for 4 weeks. | Drug | Group E |
| SU0112485 Subjects will receive 50.0 mg/d of the study drug for 1 week. | Drug | Group B |
| SU0112485 Subjects will receive 37.5 mg/d of the study drug for 1 week. | Drug | Group A |
| SU0112485 Subjects will receive 37.5 mg/d of the study drug for 2 weeks. | Drug | Group C |
Primary outcome
To evaluate the effects of SU011248 by histological examination of prostate tumors following radical prostatectomy.
Time frame: 24 months
To determine maximum tolerable dose of SU011248 when administered with prostate cancer prior to radical prostatectomy.
Time frame: 4 weeks
1 secondary outcome
To evaluate the effects of SUO11248 on tumoral phospho VEGF/PDGF, receptor TK pathways, microvessel density, antiangiogenic activities and serum PSA levels.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- Background: PubMed 12953083Weir HK, Thun MJ, Hankey BF, Ries LA, Howe HL, Wingo PA, Jemal A, Ward E, Anderson RN, Edwards BK. Annual report to the nation on the status of cancer, 1975-2000, featuring the uses of surveillance data for cancer prevention and control. J Natl Cancer Inst. 2003 Sep 3;95(17):1276-99. doi: 10.1093/jnci/djg040.
- BackgroundCancer Facts and Figures 2004. American Cancer Society, 2004.
- Background: PubMed 10235151Pound CR, Partin AW, Eisenberger MA, Chan DW, Pearson JD, Walsh PC. Natural history of progression after PSA elevation following radical prostatectomy. JAMA. 1999 May 5;281(17):1591-7. doi: 10.1001/jama.281.17.1591.
- Background: PubMed 15310996Roehl KA, Han M, Ramos CG, Antenor JA, Catalona WJ. Cancer progression and survival rates following anatomical radical retropubic prostatectomy in 3,478 consecutive patients: long-term results. J Urol. 2004 Sep;172(3):910-4. doi: 10.1097/01.ju.0000134888.22332.bb.
- Background: PubMed 15069310Kasamon KM, Dawson NA. Update on hormone-refractory prostate cancer. Curr Opin Urol. 2004 May;14(3):185-93. doi: 10.1097/00042307-200405000-00008.
- Background: PubMed 1374065Zagars GK. Prostate-specific antigen as a prognostic factor for prostate cancer treated by external beam radiotherapy. Int J Radiat Oncol Biol Phys. 1992;23(1):47-53. doi: 10.1016/0360-3016(92)90542-p.
- Background: PubMed 2468796Stamey TA, Kabalin JN, Ferrari M. Prostate specific antigen in the diagnosis and treatment of adenocarcinoma of the prostate. III. Radiation treated patients. J Urol. 1989 May;141(5):1084-7. doi: 10.1016/s0022-5347(17)41176-1.
- Background: PubMed 2473221Kabalin JN, Hodge KK, McNeal JE, Freiha FS, Stamey TA. Identification of residual cancer in the prostate following radiation therapy: role of transrectal ultrasound guided biopsy and prostate specific antigen. J Urol. 1989 Aug;142(2 Pt 1):326-31. doi: 10.1016/s0022-5347(17)38746-3.
- Background: PubMed 3113715Zagars GK, von Eschenbach AC, Johnson DE, Oswald MJ. Stage C adenocarcinoma of the prostate. An analysis of 551 patients treated with external beam radiation. Cancer. 1987 Oct 1;60(7):1489-99. doi: 10.1002/1097-0142(19871001)60:73.0.co;2-9.
- Background: PubMed 2219577Bagshaw MA, Cox RS, Ramback JE. Radiation therapy for localized prostate cancer. Justification by long-term follow-up. Urol Clin North Am. 1990 Nov;17(4):787-802.
- Background: PubMed 8490929Wheeler JA, Zagars GK, Ayala AG. Dedifferentiation of locally recurrent prostate cancer after radiation therapy. Evidence for tumor progression. Cancer. 1993 Jun 1;71(11):3783-7. doi: 10.1002/1097-0142(19930601)71:113.0.co;2-x.
- Background: PubMed 2337747Cumming JA, Ritchie AW, Goodman CM, McIntyre MA, Chisholm GD. De-differentiation with time in prostate cancer and the influence of treatment on the course of the disease. Br J Urol. 1990 Mar;65(3):271-4. doi: 10.1111/j.1464-410x.1990.tb14725.x.
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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.
Arie Belldegrun, M.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SU011248 in people with Prostate Cancer, run by Jonsson Comprehensive 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 13 inclusion and 12 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 31 Jul 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 evaluate the effects of SU011248 by histological examination of prostate tumors following radical prostatectomy. (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT00790595, which also lists 19 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 31 Jul 2012.