Main objective of this study is to test the feasibility and to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised prostate cancer. Secondary…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The feasibility of MR-guided focal laser ablation in vivo in newly diagnosed
PCa patients. Potential complications are recorded, and the success rate will
be determined by MR-imaging after 1 - 3 weeks and a combination of MR imaging
and MR-guided biopsy after 6, 12, 18, 24 and 36 months.
Secondary outcome
• To determine the accuracy of laser fibre placement under MR guidance by
measuring the 3D error at the MR images retrospectively.
• To correlate the MR results from multimodality MR and temperature mapping
with the pathological results.
• To determine the role of imaging in predicting histological outcomes of
transrectal focal laser ablation therapy in the treatment of localised prostate
cancer.
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 laser-induced interstitial
thermal therapy (LITT) or focal laser ablation. The project combines three
novel approaches implemented at our institution for the prostate: functional MR
imaging techniques to identify the tumor, MR-guided placement of laser fibers,
and temperature mapping of the prostate during thermal ablation.
Two patient cohorts will be included in this feasibility study: 10 patients
with low-risk prostate cancer scheduled for radical prostatectomy, who will get
the laser ablation as extra treatment (group A) and 20 patients with low-risk
prostate cancer, who will get the focal therapy as main treatment (group B).
Potential complications will be recorded and the success rate will be
determined by MR-imaging after 1 - 3 weeks and a combination of MR imaging and
MR-guided biopsy after 6, 12, 18, 24 and 36 months.The suggested technique
holds the promise to provide a faster, less expensive and less invasive
alternative to radical prostatectomy with also less side effects.
Study objective
Main objective of this study is to test the feasibility and to determine the
short and medium term histological cancer control of focal therapy using
MR-guided focal laser ablation therapy in the treatment of localised prostate
cancer. Secondary objectives are: to determine the accuracy of laser fibre
placement under MR guidance, to correlate the MR results from multimodality MR
and temperature mapping with the pathological results and to determine the role
of imaging in predicting histological outcomes of transrectal focal laser
ablation therapy in the treatment of localised prostate cancer.
Study design
A prospective, non randomized, pilot study. This trial will be run at the UMC
St Radboud, patients will be included at the UMC st Radboud and Canisius
Wilhelmina Ziekenhuis from December 2010 to December 2012.
Intervention
Patient group A will undergo additional MR-guided focal laser ablation before
they undergo radical prostatectomy and patient group B will receive MR-guided
focal laser ablation as main therapy for their prostate cancer
Study burden and risks
Potential patient risks in this study as mentioned by complications of
MR-guided focal laser ablation (hemorrhage, inflammation, minute risk of
perforation of urethra or bladder, and fistula formation) or of MR-guided
biopsy (hemorrhage, inflammation, minute risk of perforation of urethra or
bladder) of magnetic resonance imaging ( burden of heating and noise, risks of
contrast reactions against gadolinium) or serious unexpected events and patient
burden in form of time investment are outweighed by potential benefits for
patients. Patients in group B have a great chance to stay potent and continent,
which is a great benefit of this treatment.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria counting for both groups:
• Newly diagnosed and biopsy proven prostate cancer
• Low risk patients (PSA <= 10 ng/mL, Gleason 3+3, cT1c - T2a)
• No previous treatment for prostate cancer
• Cancer lesion located at least 2 cm away from the neurovascular bundle
according to Multimodality MR images
• Signed informed consent by patient
• Age 18 years or older
• Signed screening form (to determine exclusion for metal device/foreign bodies/claustrophobia);Additional inclusion criterion for patients in group A:
• Patients must be scheduled for a radical prostatectomy with a lesion of max 4 cm
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 focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection)
• Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging
• Patients with evidence for nodal or metastatic disease
• Patients with an estimated Glomerular Filtration Ratio (eGFR) < 40 mL/min/1.73 m2
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 | NL32695.091.10 |