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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

June 19, 2007
June 26, 2007
November 7, 2008
June 2007
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Complete list of historical versions of study NCT00491296 on ClinicalTrials.gov Archive Site
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Changes in Prostate Specific Antigen Levels During Synergo Therapy-Intravesical Chemotherapy Instillations Combined With Hyperthermia
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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.

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Observational
Time Perspective: Prospective
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Bladder Cancer
  • Device: SYNERGO
  • Device: SYNERGO-intravesical chemotherapy instillation combined with hyperthermia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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June 2007
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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
Sexes Eligible for Study: Male
30 Years to 90 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00491296
0034-07-EMC
Yes
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HaEmek Medical Center, Israel
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Principal Investigator: PEREZ DORON, M.D. HAEMEK MEDICAL CENTER, UROLOGY DEPARTMENT
Principal Investigator: Perez Doron, M.D haemek medical center
HaEmek Medical Center, Israel
June 2007