Prostate CancerPhase 2NCT02065323
A Study of Dovitinib With Androgen Deprivation Therapy (ADT) in Patients With Metastatic Prostate Cancer Receiving Primary ADT
A Phase 2 study testing Standard ADT and Dovitinib in people with Prostate Cancer, run by Oscar Goodman, Jr. at 1 site in United States.
Trial summary
This study will evaluate if adding the investigational drug Dovitinib to standard androgen ablation therapy (ADT) is beneficial in prolonging the time to disease progression in patients with metastatic prostate cancer who are receiving ADT for the first time. 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?
- Standard ADT and Dovitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Aug 2014
- 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
- Men with metastatic hormone-sensitive metastatic prostate cancer
- ECOG (WHO) performance status 0-2
- Age ≥ 18 years old
- PSA > 4.0
- Patients must have the following laboratory values:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
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- Platelets ≥ 100 x 109/L
- Hemoglobin (Hgb) > 9 g/dL
- Serum total bilirubin: ≤ 1.5 x ULN
- ALT and AST ≤ 3.0 x ULN (for patients with or without liver metastases)
- Serum creatinine ≤ 1.5 x ULN or serum creatinine > 1.5 - 3 x ULN if calculated creatinine clearance (CrCl) is ≥ 30 mL/min using the Cockroft-Gault equation
- Urine dipstick reading negative for proteinuria, or if 1+, then total urinary protein must be less than 500 mg and measured creatinine cleaners ≥ 50 mL/min/1.73m2 from a 24 hour urine collection
- Histologically or cytologically confirmed prostate cancer.
- Urine dipstick reading negative for proteinuria, or, if documentation of +1 results for protein on dipstick reading, then total urinary protein ≤ 500 mg and measured creatinine clearance ≥ 50 mL/min/1.73m2 from a 24 hour urine collection.
- Patients may have begun hormonal therapy, but must have done so within 120 days of study treatment.
- Patients must have metastatic disease (extensive or limited).
- Scans (CT chest, abdomen, and pelvis) and bone scan must be obtained within 4 weeks of treatment.
- Written informed consent obtained according to local guidelines
Who cannot join
- Patients with brain metastases
- Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer)
- Patients who have received prior cytotoxic chemotherapy within 3 years of starting study drug.
- Patients who have received targeted therapy (e.g., sunitinib, sorafenib, pazopanib) ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy.
- Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or ≤ 2 weeks prior to starting study drug in the case of localized radiotherapy (e.g., for analgesic purpose or for lytic lesions at risk of fracture), or who have not recovered from radiotherapy toxicities.
- Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury.
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- Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
- Impaired cardiac function or clinically significant cardiac diseases
- Neurological compromise or dysfunction due to metastases
- Ureteral or bladder outlet obstruction due to metastases or local invasion
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
- Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin
- Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
- Rising PSA meeting criteria for progression to CRPC
- Patients unwilling or unable to comply with the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
About this study
Official title: A Randomized Open-label Phase II Study of Oral Dovitinib in Combination With Androgen Deprivation Therapy to Delay the Onset of Castration-resistant Disease in Patients With Metastatic Prostate Cancer Undergoing Primary Androgen Deprivation Therapy
This study will evaluate if adding the investigational drug Dovitinib to standard androgen ablation therapy (ADT) is beneficial in prolonging the time to disease progression in patients with metastatic prostate cancer who are receiving ADT for the first time.
Dovitinib belongs to the class of drugs known as tyrosine kinase receptor inhibitors. Tyrosine kinase receptor inhibitors have been shown to have anti-tumor effects and inhibit new blood vessel formation. New blood vessel development is necessary for the growth and spread of certain tumors, such as prostate cancer. It is thought that by inhibiting new blood vessel formation, any existing or new tumors may be unable to grow. Dovitinib targets existing cancer cells and also works to stop the formation of new blood vessels.
Read more
Patients will be randomly assigned to received ADT alone or ADT plus Dovitinib. ADT will be administered per standard of care. Dovitinib will be taken by mouth once daily for 5 continuous days, followed by 2 days with no Dovitinib. This schedule will repeat and continue until disease progression or removal from treatment for other reasons. Participants may start ADT prior to entering the study; however, treatment with Dovitinib must begin no later than 120 days from the start of ADT.
Participants will be asked to donate blood samples for research purposes; this is an optional part of the study. Research on blood samples will study circulating tumor cells and certain biomarkers (proteins on cells) to increase the understanding of prostate cancer and explore if certain biomarkers can help predict how tumors will react to treatment. Samples of existing tumor tissue will also be examined for research purposes.
Read the detailed description
In 2010, an estimated 217,730 new cases of prostate cancer occurred with 32,050 deaths in the United States of America. Prostate cancer exhibits a unique natural history that is a function of therapies rendered. Initially, the disease is treated with androgen deprivation therapy (ADT) with substantial regression of disease in the vast majority of patients. However, the response is short-lived, on the order of 18-24 months, with subsequent resumption of cancer growth manifesting as an increasing PSA, radiographic disease progression, and progressive symptoms related to the increasing disease burden, so called metastatic castration-resistant prostate cancer (CRPC). Almost all prostate cancer deaths occur in men with metastatic castration-resistant disease (CRPC).
An appropriate therapeutic strategy would be to utilize agents in combination with ADT that could serve to extend the sensitivity of the disease to primary ADT. The hormonal sensitive state, when the tumor burden is dramatically lowered due to therapeutic response, could represent the optimal context to introduce novel agents, leading to cytoreduction and/or maintenance of the hormone-sensitive state.
It has been demonstrated that the proangiogenic factor FGF-2 appears to play a central role in angiogenesis in hormone sensitive prostate cancer (HSPC). Thus targeting FGF-2 in conjunction with primary ADT may represent a novel therapeutic strategy in the initial treatment of metastatic HSPC.
Dovitinib is a broad-targeted-profiled RTK inhibitor active against VEGF, FGF and PDGF. Anti-tumor effects for this agent may, therefore, be secondary to anti-angiogenesis, anti-proliferative activity against tumor cells, and anti-stromal activity.
The study will enroll patients with metastatic prostate disease receiving initial ADT. Participants will be randomized to receive ADT alone, or in combination with Dovitinib. Participants will be stratified based on ECOG PS, Prior ADT > or < 30 days, and disease location (bone only vs. other).
ADT will be administered per standard of care on both treatment arms. Patients randomized to the combination arm will receive ADT plus Dovitinib at a dose of 500 mg/day given on a five-days-on-two-days-off schedule. One cycle equals 28 days. Dovitinib cycles will repeat continuously until disease progression, or removal from study for other reasons. Patients must begin Dovitinib within 120 days after the start of ADT. Thereafter, patients will be allowed to remain on the study until unacceptable side effect(s) occur, or until there is disease progression to castration-resistance status.
Quality of life will be assessed during the course of the study utilizing the Functional Assessment of Cancer Therapy-Prostate (self administered FACT-P).
Blood samples obtained at specified time points will be collected for research purposes from participants who provide consent to do so. Biomarkers pertinent to the hypothesized mechanism of action will be evaluated. Circulating tumor cells (CTC) will be enumerated at baseline (CellSearch™), and every 3 months thereafter. An additional citrate tube of blood will be collected for CTC-based ex-vivo culture analysis with each CTC draw. Samples of archival prostate biopsy specimens will also be analyzed for specific proteins related to Dovitinib's mechanism of action.
- Conditions
- Prostate Cancer
- Being tested
- Standard ADT, Dovitinib
- Keywords
- Prostate Cancer, Metastatic, Hormone-sensitive, Androgen Deprivation Therapy (ADT), Castration-Resistant Prostate Cancer (CRPC), Dovitinib, TKI258, Circulating Tumor Cells
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ADTDrug
Standard androgen deprivation therapy with either continually dosed LHRH agonist or antagonist, or achieved via bilateral orchiectomy.
DovitinibDrug
Also called TKI258
Dovitinib 500 mg/day given on a five-days-on-two-days-off schedule. One cycle equals 28 days. Cycles will repeat continuously until disease progression, or removal from study for other reasons.
| Study group | Role | What they receive |
|---|---|---|
| ADT alone | Active comparator | Standard androgen deprivation therapy (LHRH analogue or orchiectomy) Receives: Drug: Standard ADT |
| ADT plus Dovitinib | Experimental | Standard androgen deprivation therapy (LHRH analogue or orchiectomy)
Dovitinib 500 mg/day given on a five-days-on-two-days-off schedule. One cycle equals 28 days. Cycles will repeat continuously until disease progression, or removal from study for other reasons. Receives: Drug: Standard ADT; Drug: Dovitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to onset of castration resistant prostate cancer (CRPC)
CRPC defined as documented presence of two of the following criteria: PSA progression, radiographic progression, and/or symptomatic deterioration due to prostate cancer.
Measured: Every 12 weeks from the start of treatment until the date of first documented progression, up to 24 months.
Secondary outcomes (6)
Effect on predictive PSA benchmarks
Comparison of PSA at baseline to PSA at 7 months following initiation of ADT, and time to PSA nadir.
Measured: PSA measured at baseline and every 12 weeks until the date of first documented progression, up to 24 months.
Overall survival
Time from first study treatment to date of death. After removal from study patients will be contacted by phone every 6 months.
Measured: From date of randomization until date of death, or patient lost to follow up. Survival will be assessed at least every 4 weeks during treatment and every 6 months after disease progression up to 5 years.
Radiographic response rate and progression free survival in patients with measurable disease.
Radiographic progression documented by CT, MRI, and/or Bone scan. For non-target osseous disease, progressive disease defined as appearance of two or more new lesions that are confirmed by confirmatory scan 6-12 weeks later.
Measured: Radiographic evaluations occur at baseline and every 12 weeks while on study until date of first documented disease progression, up to 24 months.
Adverse event frequency
Appearance of (or worsening of any pre-existing) undesirable sign(s), symptoms(s), or medical conditions(s); assessed according to CTCAE v4.0.
Measured: Assessed every 2 weeks for first 8 weeks, then every 4 weeks while on study and at 30 days following last dose of dovitinib, up to 24 months.
Changes in circulating tumor cell counts
CTC enumeration and comparison among sequential samples.
Measured: Baseline and every 3 months while on study until date of first documented progression, up to 24 months.
Quality of life
Assessed using Functional Assessment of Cancer Therapy-Prostate (self administered FACT-P)
Measured: Assessed at baseline, once every cycle during treatment, and at end of treatment (when treatment stopped for disease progression or any other reason), up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Primary completionAug 2014
Why it stopped: Terminated due to budgetary considerations and length of development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oscar Goodman, Jr.
- Sponsor type
- University, hospital or other
- Collaborators
- Comprehensive Cancer Centers of Nevada
- Responsible party
- Sponsor-investigator, Oscar Goodman, Jr., Comprehensive Cancer Centers of Nevada
- Investigators
- Oscar B Goodman, Jr., MD, PhD, Principal investigator, Comprehensive Cancer Centers of Nevada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065323
- Sponsor's protocol ID
- CCCN-PC1301
- Other IDs
- CTKI258AUS18T
- Status last verified
- Jan 2015
- First submitted
- 3 Feb 2014
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goodman OB Jr, Febbraio M, Simantov R, Zheng R, Shen R, Silverstein RL, Nanus DM. Neprilysin inhibits angiogenesis via proteolysis of fibroblast growth factor-2. J Biol Chem. 2006 Nov 3;281(44):33597-605. doi: 10.1074/jbc.M602490200. Epub 2006 Aug 28.
PubMed 16940054Horiguchi A, Zheng R, Goodman OB Jr, Shen R, Guan H, Hersh LB, Nanus DM. Lentiviral vector neutral endopeptidase gene transfer suppresses prostate cancer tumor growth. Cancer Gene Ther. 2007 Jun;14(6):583-9. doi: 10.1038/sj.cgt.7701047. Epub 2007 Apr 6.
PubMed 17415380Horiguchi A, Chen DY, Goodman OB Jr, Zheng R, Shen R, Guan H, Hersh LB, Nanus DM. Neutral endopeptidase inhibits prostate cancer tumorigenesis by reducing FGF-2-mediated angiogenesis. Prostate Cancer Prostatic Dis. 2008;11(1):79-87. doi: 10.1038/sj.pcan.4500984. Epub 2007 Jun 12.
PubMed 17563767Goodman OB Jr, Symanowski JT, Loudyi A, Fink LM, Ward DC, Vogelzang NJ. Circulating tumor cells as a predictive biomarker in patients with hormone-sensitive prostate cancer. Clin Genitourin Cancer. 2011 Sep;9(1):31-8. doi: 10.1016/j.clgc.2011.04.001. Epub 2011 Jun 25.
PubMed 21705286Mitra R, Chao OS, Nanus DM, Goodman OB Jr. Negative regulation of NEP expression by hypoxia. Prostate. 2013 May;73(7):706-14. doi: 10.1002/pros.22613. Epub 2012 Nov 8.
PubMed 23138928
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-label Phase II Study of Oral Dovitinib in Combination With Androgen Deprivation Therapy to Delay the Onset of Castration-resistant Disease in Patients With Metastatic Prostate Cancer Undergoing Primary Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT02065323
- Acronym / sponsor ID
- CCCN-PC1301
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Metastatic, Hormone-sensitive, Androgen Deprivation Therapy (ADT), Castration-Resistant Prostate Cancer (CRPC), Dovitinib, TKI258, Circulating Tumor Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated due to budgetary considerations and length of development.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oscar Goodman, Jr.University, hospital or other
- Collaborators
- Comprehensive Cancer Centers of Nevada
- Primary completion
- Aug 2014 (actual)
- First posted
- 19 Feb 2014 (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 study will evaluate if adding the investigational drug Dovitinib to standard androgen ablation therapy (ADT) is beneficial in prolonging the time to disease progression in patients with metastatic prostate cancer who are receiving ADT for the first time.
Dovitinib belongs to the class of drugs known as tyrosine kinase receptor inhibitors. Tyrosine kinase receptor inhibitors have been shown to have anti-tumor effects and inhibit new blood vessel formation. New blood vessel development is necessary for the growth and spread of certain tumors, such as prostate cancer. It is thought that by inhibiting new blood vessel formation, any existing or new tumors may be unable to grow. Dovitinib targets existing cancer cells and also works to stop the formation of new blood vessels.
Patients will be randomly assigned to received ADT alone or ADT plus Dovitinib. ADT will be administered per standard of care. Dovitinib will be taken by mouth once daily for 5 continuous days, followed by 2 days with no Dovitinib. This schedule will repeat and continue until disease progression or removal from treatment for other reasons. Participants may start ADT prior to entering the study; however, treatment with Dovitinib must begin no later than 120 days from the start of ADT.
Participants will be asked to donate blood samples for research purposes; this is an optional part of the study. Research on blood samples will study circulating tumor cells and certain biomarkers (proteins on cells) to increase the understanding of prostate cancer and explore if certain biomarkers can help predict how tumors will react to treatment. Samples of existing tumor tissue will also be examined for research purposes.
Detailed description
In 2010, an estimated 217,730 new cases of prostate cancer occurred with 32,050 deaths in the United States of America. Prostate cancer exhibits a unique natural history that is a function of therapies rendered. Initially, the disease is treated with androgen deprivation therapy (ADT) with substantial regression of disease in the vast majority of patients. However, the response is short-lived, on the order of 18-24 months, with subsequent resumption of cancer growth manifesting as an increasing PSA, radiographic disease progression, and progressive symptoms related to the increasing disease burden, so called metastatic castration-resistant prostate cancer (CRPC). Almost all prostate cancer deaths occur in men with metastatic castration-resistant disease (CRPC).
An appropriate therapeutic strategy would be to utilize agents in combination with ADT that could serve to extend the sensitivity of the disease to primary ADT. The hormonal sensitive state, when the tumor burden is dramatically lowered due to therapeutic response, could represent the optimal context to introduce novel agents, leading to cytoreduction and/or maintenance of the hormone-sensitive state.
It has been demonstrated that the proangiogenic factor FGF-2 appears to play a central role in angiogenesis in hormone sensitive prostate cancer (HSPC). Thus targeting FGF-2 in conjunction with primary ADT may represent a novel therapeutic strategy in the initial treatment of metastatic HSPC.
Dovitinib is a broad-targeted-profiled RTK inhibitor active against VEGF, FGF and PDGF. Anti-tumor effects for this agent may, therefore, be secondary to anti-angiogenesis, anti-proliferative activity against tumor cells, and anti-stromal activity.
The study will enroll patients with metastatic prostate disease receiving initial ADT. Participants will be randomized to receive ADT alone, or in combination with Dovitinib. Participants will be stratified based on ECOG PS, Prior ADT > or < 30 days, and disease location (bone only vs. other).
ADT will be administered per standard of care on both treatment arms. Patients randomized to the combination arm will receive ADT plus Dovitinib at a dose of 500 mg/day given on a five-days-on-two-days-off schedule. One cycle equals 28 days. Dovitinib cycles will repeat continuously until disease progression, or removal from study for other reasons. Patients must begin Dovitinib within 120 days after the start of ADT. Thereafter, patients will be allowed to remain on the study until unacceptable side effect(s) occur, or until there is disease progression to castration-resistance status.
Quality of life will be assessed during the course of the study utilizing the Functional Assessment of Cancer Therapy-Prostate (self administered FACT-P).
Blood samples obtained at specified time points will be collected for research purposes from participants who provide consent to do so. Biomarkers pertinent to the hypothesized mechanism of action will be evaluated. Circulating tumor cells (CTC) will be enumerated at baseline (CellSearch™), and every 3 months thereafter. An additional citrate tube of blood will be collected for CTC-based ex-vivo culture analysis with each CTC draw. Samples of archival prostate biopsy specimens will also be analyzed for specific proteins related to Dovitinib's mechanism of action.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADT alone | Active comparator | Drug: Standard ADTStandard androgen deprivation therapy (LHRH analogue or orchiectomy) |
| ADT plus Dovitinib | Experimental | Drug: Standard ADT, Drug: DovitinibStandard androgen deprivation therapy (LHRH analogue or orchiectomy) Dovitinib 500 mg/day given on a five-days-on-two-days-off schedule. One cycle equals 28 days. Cycles will repeat continuously until disease progression, or removal from study for other reasons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Men with metastatic hormone-sensitive metastatic prostate cancer
- ECOG (WHO) performance status 0-2
- Age ≥ 18 years old
- PSA > 4.0
- Patients must have the following laboratory values:
Key exclusion criteria (17 listed)
- Patients with brain metastases
- Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer)
- Patients who have received prior cytotoxic chemotherapy within 3 years of starting study drug.
- Patients who have received targeted therapy (e.g., sunitinib, sorafenib, pazopanib) ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy.
- Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or ≤ 2 weeks prior to starting study drug in the case of localized radiotherapy (e.g., for analgesic purpose or for lytic lesions at risk of fracture), or who have not recovered from radiotherapy toxicities.
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 |
|---|---|---|
| Standard ADTStandard androgen deprivation therapy with either continually dosed LHRH agonist or antagonist, or achieved via bilateral orchiectomy. | Drug | ADT alone, ADT plus Dovitinib |
| DovitinibAlso: TKI258Dovitinib 500 mg/day given on a five-days-on-two-days-off schedule. One cycle equals 28 days. Cycles will repeat continuously until disease progression, or removal from study for other reasons. | Drug | ADT plus Dovitinib |
Primary outcome
Time to onset of castration resistant prostate cancer (CRPC)
Time frame: Every 12 weeks from the start of treatment until the date of first documented progression, up to 24 months.
CRPC defined as documented presence of two of the following criteria: PSA progression, radiographic progression, and/or symptomatic deterioration due to prostate cancer.
6 secondary outcomes
Effect on predictive PSA benchmarks
Time frame: PSA measured at baseline and every 12 weeks until the date of first documented progression, up to 24 months.
Overall survival
Time frame: From date of randomization until date of death, or patient lost to follow up. Survival will be assessed at least every 4 weeks during treatment and every 6 months after disease progression up to 5 years.
Radiographic response rate and progression free survival in patients with measurable disease.
Time frame: Radiographic evaluations occur at baseline and every 12 weeks while on study until date of first documented disease progression, up to 24 months.
Adverse event frequency
Time frame: Assessed every 2 weeks for first 8 weeks, then every 4 weeks while on study and at 30 days following last dose of dovitinib, up to 24 months.
Changes in circulating tumor cell counts
Time frame: Baseline and every 3 months while on study until date of first documented progression, up to 24 months.
Quality of life
Time frame: Assessed at baseline, once every cycle during treatment, and at end of treatment (when treatment stopped for disease progression or any other reason), up to 24 months.
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 19 Jan 2015.
- Background: PubMed 16940054Goodman OB Jr, Febbraio M, Simantov R, Zheng R, Shen R, Silverstein RL, Nanus DM. Neprilysin inhibits angiogenesis via proteolysis of fibroblast growth factor-2. J Biol Chem. 2006 Nov 3;281(44):33597-605. doi: 10.1074/jbc.M602490200. Epub 2006 Aug 28.
- Background: PubMed 17415380Horiguchi A, Zheng R, Goodman OB Jr, Shen R, Guan H, Hersh LB, Nanus DM. Lentiviral vector neutral endopeptidase gene transfer suppresses prostate cancer tumor growth. Cancer Gene Ther. 2007 Jun;14(6):583-9. doi: 10.1038/sj.cgt.7701047. Epub 2007 Apr 6.
- Background: PubMed 17563767Horiguchi A, Chen DY, Goodman OB Jr, Zheng R, Shen R, Guan H, Hersh LB, Nanus DM. Neutral endopeptidase inhibits prostate cancer tumorigenesis by reducing FGF-2-mediated angiogenesis. Prostate Cancer Prostatic Dis. 2008;11(1):79-87. doi: 10.1038/sj.pcan.4500984. Epub 2007 Jun 12.
- Background: PubMed 21705286Goodman OB Jr, Symanowski JT, Loudyi A, Fink LM, Ward DC, Vogelzang NJ. Circulating tumor cells as a predictive biomarker in patients with hormone-sensitive prostate cancer. Clin Genitourin Cancer. 2011 Sep;9(1):31-8. doi: 10.1016/j.clgc.2011.04.001. Epub 2011 Jun 25.
- Background: PubMed 23138928Mitra R, Chao OS, Nanus DM, Goodman OB Jr. Negative regulation of NEP expression by hypoxia. Prostate. 2013 May;73(7):706-14. doi: 10.1002/pros.22613. Epub 2012 Nov 8.
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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.
Oscar B Goodman, Jr., MD, PhD principal investigator
Comprehensive Cancer Centers of Nevada
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 Standard ADT and Dovitinib in people with Prostate Cancer, run by Oscar Goodman, Jr. 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 18 inclusion and 17 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 19 Jan 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?
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?
Time to onset of castration resistant prostate cancer (CRPC) (time frame: Every 12 weeks from the start of treatment until the date of first documented progression, up to 24 months.). 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 NCT02065323, which also lists 5 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 Jan 2015.