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

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective

Interventions

  • Device: SYNERGO
  • Device: SYNERGO-intravesical chemotherapy instillation combined with hyperthermia

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 30 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • HaEmek Medical Center, Israel
  • Overall Official(s)
    • PEREZ DORON, M.D., Principal Investigator, HAEMEK MEDICAL CENTER, UROLOGY DEPARTMENT
    • Perez Doron, M.D, Principal Investigator, haemek medical center
  • Overall Contact(s)
    • doron perez, M.D., +972-4-6495115, perez_do@clalit.org.il

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.