Bladder CancerNCT00491296
Changes in Prostate Specific Antigen Levels During Synergo Therapy-Intravesical Chemotherapy Instillations Combined With Hyperthermia
An observational study of Bladder Cancer, run by HaEmek Medical Center, Israel at 2 sites in Israel.
Trial summary
PURPOSE: We determined whether Synergo therapy- intravesical chemotherapy instillation combined with hyperthermia instillation is associated with elevated prostate specific antigen (PSA). Read more about this study
- Who is it for?
- Ages 30 to 90 years, men only
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- SYNERGO and SYNERGO-intravesical chemotherapy instillation combined with hyperthermia
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 2 sitesIsrael
- Study dates
- Jun 2007to Jun 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Haemek MC
Afula, 18100
Department of urology
Afula, 18101
doron perez, M.D., +972-4-6495115, perez_do@clalit.org.il
About this study
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.
- Conditions
- Bladder Cancer
- Being tested
- SYNERGO, SYNERGO-intravesical chemotherapy instillation combined with hyperthermia
- Keywords
- S/P Transuretral resection of bladder tumor, Recurrent tumor after BCG Treatment
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYNERGODevice
SYNERGO-intravesical chemotherapy instillation combined with hyperthermiaDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startJun 2007
- Study completionJun 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- PEREZ DORON, M.D., Principal investigator, HAEMEK MEDICAL CENTER, UROLOGY DEPARTMENTPerez Doron, M.D, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491296
- Sponsor's protocol ID
- 0034-07-EMC
- Status last verified
- Jun 2007
- First submitted
- 19 Jun 2007
- Last updated
- 7 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Prostate Specific Antigen Levels During Synergo Therapy-Intravesical Chemotherapy Instillations Combined With Hyperthermia
- ClinicalTrials.gov ID
- NCT00491296
- Acronym / sponsor ID
- 0034-07-EMC
- Conditions
- Bladder Cancer
- Keywords
- S/P Transuretral resection of bladder tumor, Recurrent tumor after BCG Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Jun 2007 (estimated)
- First posted
- 26 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- History of prostate cancer
- Previous history of TCC stage T2 or higher
- Invasive tu of bladder
- Prior pelvic radiotherapy or systemic chemotherapy
- Active prostatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYNERGO | Device | – |
| SYNERGO-intravesical chemotherapy instillation combined with hyperthermia | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PEREZ DORON, M.D. principal investigator
HAEMEK MEDICAL CENTER, UROLOGY DEPARTMENT
Perez Doron, M.D principal investigator
haemek medical center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by HaEmek Medical Center, Israel at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact doron perez, M.D. (+972-4-6495115, perez_do@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2008.