The primary objective for this trial is to assess the local cancer control achieved with FLA in patients with localized low to intermediate risk prostate cancer (Gleason 3+3, 3+4 or Gleason 4+3).Secondary objectives are to determine effectiveness of…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The oncologic safety (PSA measurements at 6 weeks, 3, 6, 12 and 24 months; MR
imaging at 6, 12 and 24 months; and*targeted and random systematic 12-core
biopsy at 12 months post focal therapy), functional outcome, complication rates
(i.e. urinary incontinence, irritative/obstructive bowel and erectile
dysfunction), re-treatment percentage, the EORTC QLQ-PR25 scale for sexual
symptoms, ICIQ (incontinence), IPSS (urinary problems) and SHIM IIEF-5
(erectile dysfunctioning), success rate, complication rates (according to
Clavien system for surgical complications), operating time and hospital stay.
Secondary outcome
Not applicable.
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 perform a multicenter study on magnetic resonance
imaging (MRI) and robot-guided laser-induced interstitial thermal therapy
(LITT) of prostate cancer or in short focal laser ablation (FLA). FLA holds the
promise to provide a faster, less expensive and less invasive alternative to
radical prostatectomy with also less side effects. Seventy-three patients with
low to intermediate-risk localized prostate cancer, will get the focal therapy
as main treatment. Potential complications will be recorded and diagnostic MRI
and MRI-guided biopsy results will be used to assess the treatment success
rate.
Study objective
The primary objective for this trial is to assess the local cancer control
achieved with FLA in patients with localized low to intermediate risk prostate
cancer (Gleason 3+3, 3+4 or Gleason 4+3).
Secondary objectives are to determine effectiveness of FLA in men with prostate
cancer in terms of functional outcome, quality of life and complication rates.
Study design
A prospective, non-randomized, multi center study. This trial will be
coordinated by the Radboud University Medical Center. Patient recruitment will
take place at the Radboudumc (Nijmegen, The Netherlands), Alma Clinic (Paris,
France) and Sørlandet Sykehus Kristiansand (Norway) from February 2018 to
February 2020. The multiparametric MRI and the MRI and robot-guided FLA will be
performed at the site of inclusion.
Intervention
Patients will receive MRI and robot-guided focal laser ablation as main
prostate cancer treatment.
Study burden and risks
Possible complications associated with focal laser ablation are hemorrhage,
inflammation, minute risk of perforation of urethra or bladder, and fistula
formation. The use of MRI-guidance may have a burden of local heating and
noise, risks of contrast reactions against gadolinium, or serious unexpected
events and patient burden in form of time investment. These drawbacks are
outweighed by potential benefits for patients.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
1. MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging)
2. maximum MRI visible lesion size is <<= 15 mm large axis
3. 45 to 76 years old patient
4. life expectancy at the inclusion of more 10 years
5. underwent systematic TRUS-guided biopsy
6. diagnosis of prostate cancer confirmed by targeted biopsy using TRUS-MRI fusion or in-bore
MRI guided biopsies
7. criteria of low and intermediate risk of progression and eligibility for focal therapy
a. a clinical stage of maximum T2c
b. a maximum biopsy Gleason score of 4 + 3 on targeted biopsies
c. a serum prostate specific antigen < 15 ng/ml
8. patient accepting to be included in an active surveillance protocol at the end of the study, in
accordance with the recommendations of good practice
Exclusion criteria
1. history of prostate surgery
2. history of radiation therapy or pelvic trauma; history of proved acute or chronic prostatitis
3. history of tumor in the preceding 5 years (excluded: non-metastatic basal cell skin cancer)
4. severe urinary symptoms associated with benign hyperplasia of the prostate, and defined by an
IPSS score > 18
5. tumor with MRI signs of extra-capsular extension or invasion of the seminal vesicles
6. maximum cancer core length >3 mm and/or maximum Gleason score of 3+4 on systematic
biopsies outside the visible tumor area on mpMRI
7. Impossibility to obtain a valid informed consent
8. Patients unable to undergo MR imaging, including those with contra-indications
9. Contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or
abdomino perineal resection)
10. Metallic hip implant or any other metallic implant or device that distorts local magnetic field and
compromises the quality of MR imaging
11. Patients with evidence for nodal or metastatic disease
12. 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 | NL63647.091.17 |