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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2007 by HaEmek Medical Center, Israel.
Recruitment status was:  Not yet recruiting
Information provided by:
HaEmek Medical Center, Israel Identifier:
First received: June 19, 2007
Last updated: November 5, 2008
Last verified: June 2007

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 Intervention
Bladder Cancer Device: SYNERGO Device: SYNERGO-intravesical chemotherapy instillation combined with hyperthermia

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by HaEmek Medical Center, Israel:

Study Start Date: June 2007
Estimated Study Completion Date: June 2007

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

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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Please refer to this study by its identifier: NCT00491296

Contact: doron perez, M.D. +972-4-6495115

Haemek MC
Afula, Israel, 18100
Department of urology Not yet recruiting
Afula, Israel, 18101
Contact: doron perez, M.D.    +972-4-6495115   
Sponsors and Collaborators
HaEmek Medical Center, Israel
Principal Investigator: Perez Doron, M.D haemek medical center
  More Information Identifier: NCT00491296     History of Changes
Other Study ID Numbers: 0034-07-EMC
Study First Received: June 19, 2007
Last Updated: November 5, 2008

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
Urinary Bladder Diseases
Urologic Diseases processed this record on July 26, 2017