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

HaEmek Medical Center, Israel

Status: Unknown

Conditions: Bladder Cancer

Treatments: Device: SYNERGO-intravesical chemotherapy instillation combined with hyperthermia; Device: SYNERGO

Study type: Observational

Funder types: Other

Identifiers

NCT00491296

0034-07-EMC

Details and patient eligibility

About

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.

Sex: Male

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

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