Changes in Prostate Specific Antigen Levels During Synergo Therapy-Intravesical Chemotherapy Instillations Combined With Hyperthermia
Conditions
Bladder Cancer
Conditions: Keywords
S/P Transuretral resection of bladder tumor, Recurrent tumor after BCG Treatment
Study Type
Observational
Study Phase
N/A
Study Design
Time Perspective: Prospective
Intervention
Name: SYNERGO Type: Device
Name: SYNERGO-intravesical chemotherapy instillation combined with hyperthermia Type: Device
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 30 Years
Gender: Male
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
Locations
Department of urology
Afula, Israel
Status: Not yet recruiting
Contact: doron perez, M.D. - +972-4-6495115 - perez_do@clalit.org.il
Haemek MC
Afula, Israel
Status:
Start Date
June 2007
Completion Date
June 2007
Sponsors
HaEmek Medical Center, Israel
Source
HaEmek Medical Center, Israel
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page