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…
ID
Bron
Verkorte titel
Aandoening
Prostate and cancer.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Can contrast enhanced ultrasound be used for the detection of prostate lesions suspicious for cancer that can be used for brachytherapy dose adjustment.
Achtergrond van het onderzoek
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
Doel van het onderzoek
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.
Onderzoeksopzet
baseline before EBRT, baseline before brachytherapy, 2 weeks after, 3 months after, 6 months after.
Onderzoeksproduct en/of interventie
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.
Publiek
Department of urology <br>
Postbus 22660
N. Wondergem
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665793
n.wondergem@amc.nl
Wetenschappelijk
Department of urology <br>
Postbus 22660
N. Wondergem
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665793
n.wondergem@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
See inclusion criteria.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL663 |
NTR-old | NTR1168 |
Ander register | : incomplete |
ISRCTN | Wordt niet aangevraagd/Observational study |