A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment
Description
This is a prospective, open-label, randomized, cross-over, pilot study of reprogramming therapy in patients with recurrent PCa based on rising PSA only. The primary objectives are to compare the disease progression-free rate at the end of 12 weeks between 5-AZA+ATRA and no therapy and to assess safety of the 5-AZA and ATRA combination. All study enrollees will receive Lupron. After one month, they will be assigned in a 1:1 randomization to either the `5-AZA+ATRA' group or the `no therapy' group. Patients in the `5-AZA + ATRA' group will receive treatment on a 28-day cycle, in the absence of prohibitive toxicities, for 3 cycles. Patients will initially be observed for 3 cycles under either no therapy or combination therapy, before crossing over to receive the opposite treatment for another 3 cycles in the absence of prohibitive toxicities. After the treatment period, all patients will be followed for a total of 24 months from the start of the study or until the events leading to discontinuation are observed.
Study Start Date
June, 25 2018
Estimated Completion Date
August 2021
Interventions
- Drug: 5-Azacitidine
- Drug: all trans retinoic acid
- Drug: Lupron
Study ID
Icahn School of Medicine at Mount Sinai -- GCO 16-0752
Status
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Error Details:
| struct | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Cause |
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| Detail | An exception occurred while invoking an event handler method from Application.cfc. The method name is: onRequest. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Message | Event handler exception. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| RootCause |
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| StackTrace | coldfusion.runtime.EventHandlerException: Event handler exception. at coldfusion.runtime.AppEventInvoker.onRequest(AppEventInvoker.java:309) at coldfusion.filter.ApplicationFilter.invoke(ApplicationFilter.java:470) at coldfusion.filter.RequestMonitorFilter.invoke(RequestMonitorFilter.java:42) at coldfusion.filter.MonitoringFilter.invoke(MonitoringFilter.java:40) at coldfusion.filter.PathFilter.invoke(PathFilter.java:153) at coldfusion.filter.ExceptionFilter.invoke(ExceptionFilter.java:94) at coldfusion.filter.BrowserDebugFilter.invoke(BrowserDebugFilter.java:78) at coldfusion.filter.ClientScopePersistenceFilter.invoke(ClientScopePersistenceFilter.java:28) at coldfusion.filter.BrowserFilter.invoke(BrowserFilter.java:38) at coldfusion.filter.NoCacheFilter.invoke(NoCacheFilter.java:58) at coldfusion.filter.GlobalsFilter.invoke(GlobalsFilter.java:38) at coldfusion.filter.DatasourceFilter.invoke(DatasourceFilter.java:22) at coldfusion.filter.CachingFilter.invoke(CachingFilter.java:62) at coldfusion.CfmServlet.service(CfmServlet.java:219) at coldfusion.bootstrap.BootstrapServlet.service(BootstrapServlet.java:89) at org.apache.catalina.core.ApplicationFilterChain.internalDoFilter(ApplicationFilterChain.java:303) at org.apache.catalina.core.ApplicationFilterChain.doFilter(ApplicationFilterChain.java:208) at coldfusion.monitor.event.MonitoringServletFilter.doFilter(MonitoringServletFilter.java:42) at coldfusion.bootstrap.BootstrapFilter.doFilter(BootstrapFilter.java:46) at org.apache.catalina.core.ApplicationFilterChain.internalDoFilter(ApplicationFilterChain.java:241) at org.apache.catalina.core.ApplicationFilterChain.doFilter(ApplicationFilterChain.java:208) at coldfusion.inspect.weinre.MobileDeviceDomInspectionFilter.doFilter(MobileDeviceDomInspectionFilter.java:57) at coldfusion.bootstrap.BootstrapFilter.doFilter(BootstrapFilter.java:46) at org.apache.catalina.core.ApplicationFilterChain.internalDoFilter(ApplicationFilterChain.java:241) at org.apache.catalina.core.ApplicationFilterChain.doFilter(ApplicationFilterChain.java:208) at org.apache.catalina.core.StandardWrapperValve.invoke(StandardWrapperValve.java:219) at org.apache.catalina.core.StandardContextValve.invoke(StandardContextValve.java:110) at org.apache.catalina.authenticator.AuthenticatorBase.invoke(AuthenticatorBase.java:494) at org.apache.catalina.core.StandardHostValve.invoke(StandardHostValve.java:169) at org.apache.catalina.valves.ErrorReportValve.invoke(ErrorReportValve.java:104) at org.apache.catalina.core.StandardEngineValve.invoke(StandardEngineValve.java:116) at org.apache.catalina.connector.CoyoteAdapter.service(CoyoteAdapter.java:458) at org.apache.coyote.ajp.AjpProcessor.process(AjpProcessor.java:196) at org.apache.coyote.AbstractProtocol$AbstractConnectionHandler.process(AbstractProtocol.java:637) at org.apache.tomcat.util.net.JIoEndpoint$SocketProcessor.run(JIoEndpoint.java:316) at java.util.concurrent.ThreadPoolExecutor.runWorker(Unknown Source) at java.util.concurrent.ThreadPoolExecutor$Worker.run(Unknown Source) at org.apache.tomcat.util.threads.TaskThread$WrappingRunnable.run(TaskThread.java:61) at java.lang.Thread.run(Unknown Source) Caused by: coldfusion.runtime.CFPage$InvalidDateException: Date value passed to date function DateDiff is unspecified or invalid. at coldfusion.runtime.CFPage.DateDiff(CFPage.java:1604) at cftrial2ddetails2ecfm1310202973.runPage(C:\inetpub\wwwroot\trial-details.cfm:187) at coldfusion.runtime.CfJspPage.invoke(CfJspPage.java:247) at coldfusion.tagext.lang.IncludeTag.handlePageInvoke(IncludeTag.java:736) at coldfusion.tagext.lang.IncludeTag.doStartTag(IncludeTag.java:572) at coldfusion.runtime.CfJspPage._emptyTcfTag(CfJspPage.java:3011) at cfindex2ecfm944125949._factor8(C:\inetpub\wwwroot\index.cfm:302) at cfindex2ecfm944125949.runPage(C:\inetpub\wwwroot\index.cfm:1) at coldfusion.runtime.CfJspPage.invoke(CfJspPage.java:247) at coldfusion.tagext.lang.IncludeTag.handlePageInvoke(IncludeTag.java:736) at coldfusion.tagext.lang.IncludeTag.doStartTag(IncludeTag.java:572) at coldfusion.runtime.CfJspPage._emptyTcfTag(CfJspPage.java:3011) at cfApplication2ecfc953308886$funcONREQUEST.runFunction(C:\inetpub\wwwroot\Application.cfc:147) at coldfusion.runtime.UDFMethod.invoke(UDFMethod.java:487) at coldfusion.runtime.UDFMethod$ReturnTypeFilter.invoke(UDFMethod.java:420) at coldfusion.runtime.UDFMethod$ArgumentCollectionFilter.invoke(UDFMethod.java:383) at coldfusion.filter.FunctionAccessFilter.invoke(FunctionAccessFilter.java:95) at coldfusion.runtime.UDFMethod.runFilterChain(UDFMethod.java:334) at coldfusion.runtime.UDFMethod.invoke(UDFMethod.java:231) at coldfusion.runtime.TemplateProxy.invoke(TemplateProxy.java:646) at coldfusion.runtime.TemplateProxy.invoke(TemplateProxy.java:435) at coldfusion.runtime.TemplateProxy.invoke(TemplateProxy.java:405) at coldfusion.runtime.AppEventInvoker.invoke(AppEventInvoker.java:108) at coldfusion.runtime.AppEventInvoker.onRequest(AppEventInvoker.java:301) ... 38 more | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Suppressed |
|
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| TagContext |
|
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| Type | Expression | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| name | onRequest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Session:
| struct | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| authorized | no | ||||||||||||
| cfid | 8695572 | ||||||||||||
| cftoken | f65f26fa75202733-F6889243-5056-B902-14C290AD34A99CE3 | ||||||||||||
| confirm_token | 0 | ||||||||||||
| confirmed_ind | 0 | ||||||||||||
| country | [empty string] | ||||||||||||
| [empty string] | |||||||||||||
| fname | [empty string] | ||||||||||||
| last_login | [empty string] | ||||||||||||
| lname | [empty string] | ||||||||||||
| locstruct |
|
||||||||||||
| opt_in_ind | 0 | ||||||||||||
| profession | [empty string] | ||||||||||||
| professiontblvar | REF_PROFESSION | ||||||||||||
| refspecialtytblvar | REF_SPECIALTY | ||||||||||||
| refspectblvar | REF_SPEC | ||||||||||||
| sessionid | CLINICALTRIALSLOCATOR_PROD_8695572_f65f26fa75202733-F6889243-5056-B902-14C290AD34A99CE3 | ||||||||||||
| spec_id | [empty string] | ||||||||||||
| sponsored_modal | 0 | ||||||||||||
| state_cd | [empty string] | ||||||||||||
| u_spec | [empty string] | ||||||||||||
| urltoken | CFID=8695572&CFTOKEN=f65f26fa75202733-F6889243-5056-B902-14C290AD34A99CE3 | ||||||||||||
| user_id | [empty string] | ||||||||||||
| user_type | [empty string] | ||||||||||||
| zip | [empty string] | ||||||||||||
Form:
| struct [empty] |
|---|
CGI:
| struct | |
|---|---|
| AUTH_PASSWORD | [empty string] |
| AUTH_TYPE | [empty string] |
| AUTH_USER | [empty string] |
| CERT_COOKIE | [empty string] |
| CERT_FLAGS | [empty string] |
| CERT_ISSUER | [empty string] |
| CERT_KEYSIZE | 256 |
| CERT_SECRETKEYSIZE | 4096 |
| CERT_SERIALNUMBER | [empty string] |
| CERT_SERVER_ISSUER | C=US, S=Arizona, L=Scottsdale, O="GoDaddy.com, Inc.", OU=http://certs.godaddy.com/repository/, CN=Go Daddy Secure Certificate Authority - G2 |
| CERT_SERVER_SUBJECT | OU=Domain Control Validated, CN=*.clinicaltrialslocator.com |
| CERT_SUBJECT | [empty string] |
| CF_TEMPLATE_PATH | C:\inetpub\wwwroot\index.cfm |
| CONTENT_LENGTH | 0 |
| CONTENT_TYPE | [empty string] |
| CONTEXT_PATH | [empty string] |
| GATEWAY_INTERFACE | CGI/1.1 |
| HTTPS | on |
| HTTPS_KEYSIZE | 256 |
| HTTPS_SECRETKEYSIZE | 4096 |
| HTTPS_SERVER_ISSUER | C=US, S=Arizona, L=Scottsdale, O="GoDaddy.com, Inc.", OU=http://certs.godaddy.com/repository/, CN=Go Daddy Secure Certificate Authority - G2 |
| HTTPS_SERVER_SUBJECT | OU=Domain Control Validated, CN=*.clinicaltrialslocator.com |
| HTTP_ACCEPT | text/html,application/xhtml+xml,application/xml;q=0.9,*/*;q=0.8 |
| HTTP_ACCEPT_ENCODING | br,gzip |
| HTTP_ACCEPT_LANGUAGE | en-US,en;q=0.5 |
| HTTP_CONNECTION | Keep-Alive |
| HTTP_COOKIE | [empty string] |
| HTTP_HOST | clinicaltrialslocator.com |
| HTTP_REFERER | [empty string] |
| HTTP_URL | [empty string] |
| HTTP_USER_AGENT | CCBot/2.0 (https://commoncrawl.org/faq/) |
| LOCAL_ADDR | clinicaltrialslocator.com |
| PATH_INFO | /index.cfm |
| PATH_TRANSLATED | C:\inetpub\wwwroot\index.cfm |
| QUERY_STRING | pg=trial-details&nct_id=NCT03572387&srch_radius=0&srch_zip=06828&srch_phase=&alpha_filter=A&actively_recruiting=Y&srch_condition= |
| REMOTE_ADDR | 75.101.173.236 |
| REMOTE_HOST | 75.101.173.236 |
| REMOTE_USER | [empty string] |
| REQUEST_METHOD | GET |
| SCRIPT_NAME | /index.cfm |
| SERVER_NAME | clinicaltrialslocator.com |
| SERVER_PORT | 443 |
| SERVER_PORT_SECURE | 1 |
| SERVER_PROTOCOL | HTTP/1.1 |
| SERVER_SOFTWARE | Microsoft-IIS/8.5 |
| WEB_SERVER_API | [empty string] |
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