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Changes in Prostate Specific Antigen Levels During Synergo Therapy-Intravesical Chemotherapy Instillations Combined With Hyperthermia

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ClinicalTrials.gov Identifier: NCT00491296
Recruitment Status : Unknown
Verified June 2007 by HaEmek Medical Center, Israel.
Recruitment status was:  Not yet recruiting
First Posted : June 26, 2007
Last Update Posted : November 7, 2008
Sponsor:
Information provided by:
HaEmek Medical Center, Israel

Tracking Information
First Submitted Date June 19, 2007
First Posted Date June 26, 2007
Last Update Posted Date November 7, 2008
Study Start Date June 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Changes in Prostate Specific Antigen Levels During Synergo Therapy-Intravesical Chemotherapy Instillations Combined With Hyperthermia
Official Title Not Provided
Brief Summary

PURPOSE: We determined whether Synergo therapy- intravesical chemotherapy instillation combined with hyperthermia instillation is associated with elevated prostate specific antigen (PSA). MATERIALS AND METHODS: We will treat 25 consecutive patients with bladder cancer with a 6-week course of Synergo therapy, followed by cystoscopy at 6 weeks. Blood samples for PSA determination will obtain before each synergo therapy application and at cystoscopy with each patient also serving as a control.

Evaluating changes in PSA level in patients undergoing treatment with Synergo delivered local hyperthermia combined with intravesical instillation of Mitomycin C for adjuvant treatment or pt. with recurrent tu of bladder post TURT with BCGtreatment.

Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Bladder Cancer
Intervention
  • Device: SYNERGO
  • Device: SYNERGO-intravesical chemotherapy instillation combined with hyperthermia
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Enrollment Not Provided
Original Enrollment Not Provided
Estimated Study Completion Date June 2007
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Recurrent transitional cell carcinoma of urinary bladder post endoscopic resection
  • PSA Prior synergo therapy application<10
  • Normal rectal examination
  • Patients willing to sign informed consent according

Exclusion Criteria:

  • History of prostate cancer
  • Previous history of TCC stage T2 or higher
  • Invasive tu of bladder
  • Prior pelvic radiotherapy or systemic chemotherapy
  • Active prostatitis
  • Active tuberculosis
Sex/Gender
Sexes Eligible for Study: Male
Ages 30 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00491296
Other Study ID Numbers 0034-07-EMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor HaEmek Medical Center, Israel
Collaborators Not Provided
Investigators
Principal Investigator: PEREZ DORON, M.D. HAEMEK MEDICAL CENTER, UROLOGY DEPARTMENT
Principal Investigator: Perez Doron, M.D haemek medical center
PRS Account HaEmek Medical Center, Israel
Verification Date June 2007