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Clinical Trials/NCT00491296
NCT00491296UnknownNot Applicable

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

HaEmek Medical Center, Israel2 sites in 1 countryStarted: June 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Locations
2

Study Overview

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.

Study Design

Study Type
Observational
Time Perspective
Prospective

Eligibility Criteria

Ages
30 Years to 90 Years (Adult, Older Adult)
Sex
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

Investigators

Sponsor Class
Other

Study Sites (2)

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