Main objective of this study is to test the safety and feasibility of MR-guided focal cryosurgery in newly diagnosed prostate cancer patients and in patients with recurrent prostate cancer after radiotherapy. Secondary objectives are: to determine…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Prostatic disorders (excl infections and inflammations)
- Male genital tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The safety and feasibility of MR-guided focal cryosurgery in vivo in newly
diagnosed prostate cancer patients and in patients with recurrent prostate
cancer after radiotherapy is described by potential complications and
ASTRO-criteria for disease-free survival.
Secondary outcome
The accuracy of cryoneedle placement under MR guidance is given by measuring
the in plane error at the MR images retrospectively. The accuracy of MR
temperature mapping by measuring the temperature with MR compatible temperature
sensors. The correlation between the MR results from multimodality MR and
temperature mapping with the pathological results.
Background summary
Prostate cancer is the most frequent malignancy in the male population of
developed countries and has a substantial socio-economic impact.
This project has the goal to develop and test the feasibility of a novel focal
treatment for these patients, namely MR-guided cryoablation. The project
combines three novel approaches implemented at our institution for the
prostate: functional MR imaging techniques to identify the tumor recurrence, MR
robot-guided placement of probes, and temperature mapping of the prostate
during thermal ablation.
Two patient cohorts will be included in this feasibility study: 10 patients
with unilateral prostate cancer scheduled for radical prostatectomy (group A)
and 20 patients with biopsy-proven local recurrence (group B). Potential
complications will be recorded and ASTRO criteria for disease-free survival
will be used to assess the success rate.
The suggested technique holds the promise to provide a faster, less expensive
and less invasive alternative to salvage prostatectomy or radiotherapy with
also less side effects.
Study objective
Main objective of this study is to test the safety and feasibility of MR-guided
focal cryosurgery in newly diagnosed prostate cancer patients and in patients
with recurrent prostate cancer after radiotherapy. Secondary objectives are: to
determine the accuracy of cryoneedle placement under MR guidance, to assess the
accuracy of MR temperature mapping and to correlate the MR imaging results from
multimodality MR and temperature mapping with the whole mount section
histopathology.
Study design
A prospective, non randomized, multicentre pilot study. This trial will be run
at the UMC St Radboud, where patients will be included in the UMC st Radboud
and Canisius Wilhelmina Ziekenhuis from September 2010 to September 2012.
Intervention
Patient group A will undergo additional MR-guided focal cryosurgery before they
undergo radical prostatectomy and patient group B will receive MR-guided
cryosurgery instead of US-guided cryosurgery.
Study burden and risks
Potential patient risks in this study as mentioned by complications of
cryosurgery, or serious unexpected events and patient burden in form of time
investment and possible discomfort of MR examinations and cryosurgery are
outweighed by potential benefits for patients. Patients will possibly benefit
from a more accurate needle placement and consequent cryosurgery through MR
guidance and consequently their individual risk stratification will be
optimalized.
Postbus 9101
6500 HB Nijmegen
Nederland
Postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
We plan to enroll thirty patients in total, divided over two groups; A and B. Ten patients with newly diagnosed and pathological proven PCa, which have a tumor confined to one prostate lobe and which is not located near the neurovascular bundle and no prior hormonal or radiation treatment will be included in group A. In group B twenty patients with biopsy-proven local recurrence of the prostate without distant metastases after radiotherapy will be included.;Additional inclusion criteria counting for both groups:
• 18 years of age or more
• Pathologically proven PCa
• Signed screening form (to search for metal device/foreign bodies/claustrophobia)
• Signed IRB-approved informed consent form
Exclusion criteria
• Impossibility to obtain a valid informed consent
• Patients unable to undergo MR imaging, including those with contra-indications
• Contra-indications to MR guided cryosurgery (colitis ulcerosa, rectal pathology or dominoperineal resection)
• Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging
• A prostate volume > 50 mL
• No data available from whole-mount step-section pathologic analysis to use as reference standard (group A)
Design
Recruitment
Medical products/devices used
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 | NL32429.091.10 |