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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

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.


Condition or disease Intervention/treatment
Bladder Cancer Device: SYNERGO Device: SYNERGO-intravesical chemotherapy instillation combined with hyperthermia

Study Type : Observational
Time Perspective: Prospective
Study Start Date : June 2007
Estimated Study Completion Date : June 2007

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491296


Contacts
Contact: doron perez, M.D. +972-4-6495115 perez_do@clalit.org.il

Locations
Israel
Haemek MC
Afula, Israel, 18100
Department of urology Not yet recruiting
Afula, Israel, 18101
Contact: doron perez, M.D.    +972-4-6495115    perez_do@clalit.org.il   
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: PEREZ DORON, M.D. HAEMEK MEDICAL CENTER, UROLOGY DEPARTMENT
Principal Investigator: Perez Doron, M.D haemek medical center

ClinicalTrials.gov Identifier: NCT00491296     History of Changes
Other Study ID Numbers: 0034-07-EMC
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: November 7, 2008
Last Verified: June 2007

Keywords provided by HaEmek Medical Center, Israel:
S/P Transuretral resection of bladder tumor
Recurrent tumor after BCG Treatment

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases