No registrations found.
ID
Source
Brief title
Health condition
Prostate and cancer.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Can contrast enhanced ultrasound be used for the detection of prostate lesions suspicious for cancer that can be used for brachytherapy dose adjustment.
Secondary outcome
Can contrast enhanced ultrasound of the prostate be used to follow up suspicious lesions of the prostate in prostate cancer patients after brachytherapy.
Background summary
Brachytherapy 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
Study objective
Brachytherapy 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.
Study design
baseline before EBRT, baseline before brachytherapy, 2 weeks after, 3 months after, 6 months after.
Intervention
Patients 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.
Department of urology <br>
Postbus 22660
N. Wondergem
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665793
n.wondergem@amc.nl
Department of urology <br>
Postbus 22660
N. Wondergem
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665793
n.wondergem@amc.nl
Inclusion criteria
1. Histologically proven adenocarcinoma of the prostate;
2. Patients treated by external beam radiotherapy followed by a pulsed dose-rate (PDR) brachytherapy boost;
3. Age ¡Ü 80 years;
4. WHO performance status ¡Ü 2 (appendix B);
5. International Prostate Symptom Score (IPSS) ¡Ü 20 (appendix C);
6. Maximal urinary flow ¡Ý 10 ml/sec;
7. Postvoiding residual bladder volume ¡Ü 200 ml;
8. Prostate volume on trans rectal ultrasound ¡Ü 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 criteria
See inclusion criteria.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL663 |
| NTR-old | NTR1168 |
| Other | : incomplete |
| ISRCTN | Wordt niet aangevraagd/Observational study |