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Contrast enhanced ultrasound imaging to support prostate cancer brachytherapy treatment and follow up after treatment.


- candidate number2945
- NTR NumberNTR1168
- ISRCTNWordt niet aangevraagd/Observational study
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-dec-2007
- Secondary IDsincomplete 
- Public TitleContrast enhanced ultrasound imaging to support prostate cancer brachytherapy treatment and follow up after treatment.
- Scientific TitleContrast enhanced ultrasound imaging to support prostate cancer brachytherapy treatment and follow up after treatment.
- ACRONYMCEUS to support and follow up prostate cancer brachytherapy
- hypothesisBrachytherapy is globally used as a primary treatment for prostate cancer. The advantage of brachytherapy is that the radiation dose on healthy organs can be limited. Because prostate cancer is a multifocal disease the whole prostate has to be irradiated. With the introduction of 3-dimensional radiotherapy it became possible to treat the prostate gland to high doses without increasing toxicity. In this study new treatment techniques are being used to increase the radiation dose on those places where cancer existence is suspected based on contrast enhanced ultrasound imaging. By increasing the radiation dose on areas suspicious of cancer oncological outcomes should improve.
Suspicious lesions found with contrast enhanced ultrasound should decrease or disappear during the following up of patients after brachytherapy.
- Healt Condition(s) or Problem(s) studiedProstate cancer
- Inclusion criteria1. Histologically proven adenocarcinoma of the prostate;
2. Patients treated by external beam radiotherapy followed by a pulsed dose-rate (PDR) brachytherapy boost;
3. Age 80 years;
4. WHO performance status 2 (appendix B);
5. International Prostate Symptom Score (IPSS) 20 (appendix C);
6. Maximal urinary flow 10 ml/sec;
7. Postvoiding residual bladder volume 200 ml;
8. Prostate volume on trans rectal ultrasound 60 ml;
9. No inflammatory bowel diseases such as colitis ulcerosa or M. Crohn;
10. No metallic hip prosthesis;
11. No TURP within 6 months before radiation treatment;
12. No co-morbidity not allowing general or spinal anesthesia;
13. No cardiac diseases:
a. Coronary ischemic hart disease;
b. Coronary artery intervention in the last year;
c. Acute or class III/IV cardiac failure;
d. Severe heart arrhythmia;
e. Right-to-left shunt;
f. Pulmonary hypertension (pulmonary artery pressure > 90 mmHg);
14. No uncontrolled systemic hypertension;
15. No adult respiratory distress syndrome;
16. No prior radiotherapy on prostate or pelvic area;
17. Possible to comply with follow-up;
18. Written informed consent.
- Exclusion criteriaSee inclusion criteria.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2007
- planned closingdate1-jan-2009
- Target number of participants10
- InterventionsPatients will undergo a total of 5 transrectal contrast enhanced ultrasound investigations of the prostate before and after standard brachytherapy treatment. To administer the contrast agent, patients will receive an intravenous infusion line.
- Primary outcomeCan contrast enhanced ultrasound be used for the detection of prostate lesions suspicious for cancer that can be used for brachytherapy dose adjustment.
- Secondary outcomeCan contrast enhanced ultrasound of the prostate be used to follow up suspicious lesions of the prostate in prostate cancer patients after brachytherapy.
- Timepointsbaseline before EBRT, baseline before brachytherapy, 2 weeks after, 3 months after, 6 months after.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES N. Wondergem
- CONTACT for SCIENTIFIC QUERIES N. Wondergem
- Sponsor/Initiator Academic Medical Center (AMC), Department of Urology
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryBrachytherapy is globally used as a primary treatment for prostate cancer. The advantage of brachytherapy is that the radiation dose on healthy organs can be limited. Because prostate cancer is a multifocal disease the whole prostate has to be irradiated. With the introduction of 3-dimensional radiotherapy it became possible to treat the prostate gland to high doses without increasing toxicity. In this study new treatment techniques are being used to increase the radiation dose on those places where cancer existence is suspected based on contrast enhanced ultrasound imaging. Afetr brachytherapy patients will undergo 3 contrast enhanced ultrasound investigations on determined moments in time to follow up suspicious lesions
- Main changes (audit trail)
- RECORD13-dec-2007 - 12-nov-2008


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