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

NCT ID: NCT00491296

Last Updated: 2008-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Cancer

Keywords

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S/P Transuretral resection of bladder tumor Recurrent tumor after BCG Treatment

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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SYNERGO

Intervention Type DEVICE

SYNERGO-intravesical chemotherapy instillation combined with hyperthermia

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Principal Investigators

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PEREZ DORON, M.D.

Role: PRINCIPAL_INVESTIGATOR

HAEMEK MEDICAL CENTER, UROLOGY DEPARTMENT

Perez Doron, M.D

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Locations

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Haemek MC

Afula, , Israel

Site Status

Department of urology

Afula, , Israel

Site Status

Countries

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Israel

Central Contacts

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doron perez, M.D.

Role: CONTACT

Phone: +972-4-6495115

Email: [email protected]

Facility Contacts

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doron perez, M.D.

Role: primary

Other Identifiers

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0034-07-EMC

Identifier Type: -

Identifier Source: org_study_id