MR Image Guided Focal Therapy in Prostate Cancer
18 Years
N/A
Male
Prostate Cancer, Prostatic Neoplasms
Trial Information
MR Image Guided Focal Therapy in Prostate Cancer
Background:
- Pilot study is designed to evaluate the safety and feasibility of thermal laser
ablation of focal prostate tumors.
- Prostate cancer is relatively slow growing, with doubling times for local tumors
estimated at 2 to 4 years.
- Some prostate cancers prove to be small, low grade, and noninvasive and they appear to
pose little risk to the life or health of the host. Recent patient series suggest that
20% to 30% of men undergoing radical prostatectomy have pathologic features in the
radical prostatectomy specimen consistent with an insignificant or indolent cancer
which poses little threat to life or health.
- We propose that patients with low volume and low grade disease can be best served with
focal ablation of the visible prostate cancer without the side effects of urinary
incontinence and erectile dysfunction associated with radiation therapy or radical
surgery.
Objectives:
Primary Objective:
-To determine feasibility and safety of magnetic resonance image-guided focal laser ablation
of biopsy confirmed and MR visible prostate cancer.
Secondary Objective:
- To evaluate tolerability of treatment
- To determine changes in imaging and biopsy characteristics after thermal ablation of
localized prostate cancer
- To obtain preliminary data, as a follow-up to this study, regarding the effect of
thermal ablation using Visualase on short and long term complication rate.
- To compare Visualase estimates of thermal damage to post contrast MRI images.
- Determine outcome of laser ablation for treatment of prostate cancer using serial PSA,
PSA density, changes in imaging, IPSS, and SHIM.
Eligibility:
- Greater than 18 years of age
- Organ confined prostate cancer, observed on MR, and confirmed by Transrectal biopsy
- Preoperative workup as dictated by the NCCN.org prostate cancer guidelines
- PSA < 15 ng or PSA density < 0.15 ng/ml in patients with a PSA > 15 ng
Design:
- Pilot study, testing feasibility, safety and tolerability of thermal ablation of focal
prostate cancer
- It is anticipated that 15 patients will be accrued for this study
Inclusion Criteria
- INCLUSION CRITERIA:
- Men greater than 18 years of age
- Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR
imaging
- Prostate cancer is diagnosed by transrectal ultrasound guided standard 12 core biopsy
or MR image guided biopsies
- Gleason Score less than or equal to 7 (3+4), less than or equal to 3 cores
positive in a standard 12 core biopsy or less than or equal to 4 cores positive
on MR image guided biopsy where in 2 cores are taken from each of the two MRI
target lesions
- If the standard biopsy cores are positive, they must be from the same location
in the prostate as MR Lesion was biopsied and proven to be cancer. (Left /
Right, Base, Mid Gland, Apex).
- MRI obtained within 6 months of ablation
- Metastatic Disease work up as per NCCN guidelines (www.nccn.org) - Bone scan
indicated to r/o metastatic disease if [clinical T1 and PSA > 20 or T2 and PSA >
10]
- PSA less than or equal to 15 ng/ml or PSA density less than or equal to 0.15 ng/ml(2)
in patients with a PSA > 15 ng/ml
- The patient has given written informed consent after the nature of the study and
alternative treatment options have been explained.
- Patients who present with local recurrence or residual tumor after prostate cancer
treatment which is visible on MRI.
EXCLUSION CRITERIA:
- The presence of 3 or more MR Visible lesions positive on biopsy
- The presence of extra capsular, seminal vesical invasion or metastatic disease.
- Patient is unable to tolerate MRI (foreign body, i.e. pacemaker or other implanted
device; claustrophobia; inability to tolerate rectal coil; etc )
- Patient with inability to follow up
- Acute urinary tract infection
- Lower urinary tract symptoms defined by a International Prostate symptom score (IPSS)
> 20
- Patients with renal insufficiency with an estimated glomerular filtration (EGF) < =
30 are excluded, due to they will not be able to undergo gadolinium enhance MRI.
- Patients with Uncontrolled Coagulopathies who are at increased risk of bleeding.
- Altered mental status preventing consent or answering questions during conduct of the
trial will be excluded for safety purposes.
- Other serious illnesses according to the PI: involving the cardiac, respiratory, CNS,
renal or hepatic organ systems, which would preclude study completion or impede the
determination of causality of any complications experienced during the conduct of
this study.
- A Standard 12 core biopsy positive for cancer with no corresponding MR targeted
lesion positive for cancer in the same general region of the prostate (Right Apex,
Right Mid Gland, Right Base, Left Base, Left Mid Gland, Left Apex)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine feasibility and safety of magnetic resonance image-guided focal laser ablation of biopsy confirmed and MR visible prostate cancer.
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Peter A Pinto, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
110158
NCT ID:
NCT01377753
Start Date:
May 2011
Completion Date:
April 2014
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
- Toxicity
- Thermal Ablation/Damage
- Localized Prostate Cancer
- Laser Ablation
- PSA Levels
- Prostate Cancer
- Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |
