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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Information from the National Library of Medicine

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 identifier (NCT number): 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 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
Urinary Bladder Diseases
Urologic Diseases