Clinical Trials Logo
  1. Home
  2. Bladder Cancer
  3. NCT00491296
  4. Details
NCT00491296 Clinical Trial

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

Bladder Cancer Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00491296
Other study ID # 0034-07-EMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 19, 2007
Last updated November 5, 2008
Start date June 2007
Est. completion date June 2007

Study information
Verified date June 2007
Source HaEmek Medical Center, Israel
Contact doron perez, M.D.
Phone +972-4-6495115
Email perez_do@clalit.org.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 0
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 30 Years to 90 Years
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• SYNERGO

• SYNERGO-intravesical chemotherapy instillation combined with hyperthermia

Locations
Country Name City State
Israel Department of urology Afula
Israel Haemek MC Afula

Sponsors (1)
Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06034015 - A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers Phase 1
Recruiting NCT04235764 - En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
Completed NCT02371447 - VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer Phase 1/Phase 2
Recruiting NCT04081246 - Transurethral Modified En Bloc Resection For Large Bladder Tumours. N/A
Recruiting NCT06059547 - Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for Treatment of Muscle Invasive Bladder Cancer Phase 2
Terminated NCT04779489 - Checkpoint Inhibitor and Radiation Therapy in Bulky, Node-Positive Bladder Cancer N/A
Not yet recruiting NCT04493489 - Propranolol Adjuvant Treatment of Bladder Cancer Phase 2
Completed NCT03520231 - Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases Phase 2
Recruiting NCT04537221 - Nordic Cystectomy Study III - Transfusion
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Completed NCT01955408 - Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment N/A
Completed NCT04487457 - Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT05562791 - A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer Phase 1
Completed NCT00199849 - NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine Phase 1
Completed NCT02781428 - To Detect the Sensitivity of the UroMark Assay
Recruiting NCT04738630 - Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer Phase 2
Completed NCT03980041 - Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) Phase 2
Active, not recruiting NCT03978624 - Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer Phase 2
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A