The goal of this project is to investigate the clinical feasibility of the robotic MRI-guided implant system for the implementation of fiducial gold markers for position verification for external beam radiation (or Intensity Modulated Radiotherapy (…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We consider this intervention feasible if none of the patients suffer from
grade 3 toxicity or more as a consequence of the intervention (as defined by
the Common Toxicity Criteria Version 3.0 (CTC) for a selection of categories).
In addition, a decrease in quality of life (QoL) score (following Rand-36,
QLQ-C30 and QLQ-PR25 questionnaires) not more than mean 10 points from baseline
for the total group, is considered to be acceptable. Pain will be evaluated
using the visual-analogic scale (VAS).
Secondary outcome
Not applicable.
Background summary
In the process of diagnosis and treatment of patients with prostate cancer,
several manual interventions are guided by transrectal ultrasound (TRUS). We
have developed a MRI guided single needle robotic implant system to replace
this method. This new system offers new and better possibilities in the
diagnosis and treatment of prostate cancer. Under MRI guidance, we expect
prostate biopsies, placement of position verification markers, external beam
radiation and brachytherapy to be performed more accurate and with fewer side
effects than formerly. This may result in higher tumour control rates and less
toxicity. We begin the clinical introduction of the robotic system with the
implantation of position verification markers for external beam radiation, as
for this purpose the exact location of the markers is not critical for
treatment outcome.
Study objective
The goal of this project is to investigate the clinical feasibility of the
robotic MRI-guided implant system for the implementation of fiducial gold
markers for position verification for external beam radiation (or Intensity
Modulated Radiotherapy (IMRT)) treatment, in patients with prostate cancer.
Study design
Intervention study.
Intervention
20 patients will receive three gold markers by the robotic MRI-guided implant
system.
Study burden and risks
The associated risk includes extra toxicity caused by the robotic system, and a
decrease in quality of life during and direct after the intervention. However,
based on preliminary results, tapping of the needle by the robotic system is
expected to cause less pain and tissue deformation then the conventional manual
method.
A benefit associated with participation is a decreases risk of marker
implantation outside of the prostate, e.g. through the rectal wall, a
complication that is sometimes caused by the conventional method.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
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.
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 |
|---|---|
| CCMO | NL21143.041.08 |