Clinical feasibility of a MRI guided robotic system for implantation of position verification markers in the prostate prior to radiotherapy.

Completed

Conditions: prostate cancer
prostate carcinoma
10038597

Registration Number: NL-OMON31479

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Presence of biopsy proven prostate carcinoma and indication for external beam radiotherapy and therefore gold marker implantation (tumour stadium T1-2N0M0 and no possibilities for brachytherapy or tumour stadium T3N0M0, plus a sufficient physical condition defined as a Karnofsky score >70 percent).

Exclusion Criteria

- Contra-indication for MR imaging (following the UMCU Radiology protocol, see also page 13 of the study protocol)
- Claustrophobia
- Artificial hip replacement
- Contra-indication for gold marker implantation: Use of anti-coagulants which cannot be stopped prior to intervention, prostate intervention in history (transurethral resection of the prostate) or infection, fistula or wounds in the perineal area.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We consider this intervention feasible if none of the patients suffer from<br /><br>grade 3 toxicity or more as a consequence of the intervention (as defined by<br /><br>the Common Toxicity Criteria Version 3.0 (CTC) for a selection of categories).<br /><br>In addition, a decrease in quality of life (QoL) score (following Rand-36,<br /><br>QLQ-C30 and QLQ-PR25 questionnaires) not more than mean 10 points from baseline<br /><br>for the total group, is considered to be acceptable. Pain will be evaluated<br /><br>using the visual-analogic scale (VAS).</p><br>

Secondary Outcome Measures