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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22373

Enrollment

Registered

2007-12-13

Start date

2007-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate and cancer.

Interventions

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

Eligibility

Inclusion criteria

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

Exclusion criteria: See inclusion criteria.

Design outcomes

Primary

Measure	Time frame
Can contrast enhanced ultrasound be used for the detection of prostate lesions suspicious for cancer that can be used for brachytherapy dose adjustment.	—

Secondary

Measure	Time frame
Can contrast enhanced ultrasound of the prostate be used to follow up suspicious lesions of the prostate in prostate cancer patients after brachytherapy.	—

Contacts

Public ContactN. Wondergem

Academic Medical Centre Amsterdam Department of urology Postbus 22660

n.wondergem@amc.nl+31 (0)20 5665793

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)