Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Fusion Guided Focal Laser Ablation of Prostate Cancer

Summary: Background:
  Prostate cancer is the most common non-skin cancer in U.S. men. Treatments for early or less aggressive disease are limited. Researchers want to test a device that destroys cancerous tissue with laser energy. They want to see if using it with ultrasound is more comfortable than using it with magnetic resonance imaging (MRI).
  Objectives:
  To test a cooled laser applicator system to treat prostate cancer lesions. To see if ultrasound imaging is a practical and feasible treatment with laser ablation for focal prostate cancer treatment.
  Eligibility:
  Men at least 18 years old with prostate cancer seen on MRI that has not spread in the body.
  Design:
  Participants will be screened with standard cancer care tests. These can include physical exam, lab tests, and MRI. For the MRI, they lie in a machine that takes pictures. Participants will have a prostate biopsy. Needle samples will be taken from 12 places in the prostate. This will be guided by MRI and ultrasound, which is obtained through a coil in the rectum.
  Participants will stay at the clinic for 1 2 days. A cooling catheter (plastic tube) will be put in the bladder. Ultrasound will guide the laser applicator directly to the tumor.
  The cooling catheter will be removed. A different catheter will be put in the urethra to keep the bladder emptied.
  The next day, participants will have a physical exam and a PSA blood test.
  Participants will have 6 follow-up visits over 3 years. At each visit, they will have a physical exam and lab tests. At some visits, they will also have an MRI or other scans and a prostate biopsy.

Detailed description: Background:
  Pilot study to evaluate the feasibility of real time ultrasound imaging to guide thermal laser ablation of low risk 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 life or health. 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 that poses little threat to life or health.
  An NIH/NCI protocol number 11-C-0158 titled MR Image guided focal laser ablation therapy of prostate cancer has treated 15 patients without major complication over the past 5 years. Out of 15 patients, 3 have had evidence of disease reoccurrence. This data is being prepared for publication (verbal communication with Peter Pinto, MD, principal investigator), however it requires a very long and resource-intensive MRI imaging, which may be a barrier to broad translation to the community setting. Specialized custom and expensive MRI-compatible equipment is also required. Focal laser ablation for prostate cancer using the Medtronic-Visualase laser is FDA cleared.
  NIH / NCI clinical trials have performed MRI + ultrasound (US) fusion biopsy in nearly 1500 patients, > 30,000 biopsies over past 12 years.
  We propose to perform ultrasound (US) guided focal laser ablation with fusion visualization and co-display of pre-acquired MRI during the treatment of patients with low volume and low-grade disease.
  Objectives:
  To determine the feasibility of treating biopsy-confirmed and MR-visible, low-grade prostate tumor(s) using ultrasound (US) image-guided focal laser interstitial thermal ablation).
  Eligibility:
  Patients must have localized, low-volume, non-aggressive, low risk prostate cancer that is MR visible and confirmed by needle biopsy.
  Tumor must be confined within the prostate and involves one-half of one lobe or less.
  PSA < 15 ng/ml, or PSA density (PSA/prostate volume) < 0.15 ng/mL2 in patients with a PSA > 15 ng/mL
  Men more than or equal to than 18 years of age.
  Preoperative clearance by NIH Department of Anesthesia and Surgical Services.
  No evidence of metastatic disease per NCCN guidelines
  Design:
  Pilot study, testing feasibility of ultrasound-guided thermal ablation of focal prostate cancer.
  A total of 30 patients will be enrolled to yield 20 evaluable patients

Eligibility: -  INCLUSION CRITERIA:
  -  Patients must have clinically localized, low-volume, non-aggressive, low risk cancer: Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR imaging.
  -  T1c Tumor identified by needle biopsy (e.g., because of elevated PSA)
  -  T2a Tumor confined within prostate and involves one-half of one lobe or less
  -  Prostate cancer is diagnosed by transrectal ultrasound guided standard 12 core biopsy or MR image guided biopsy, or MR / US fusion guided biopsies. There may be up to 2 focal targets that are well-defined by imaging as verified by at least 2 radiologists
  -  Gleason Score less than or equal to 7 (3+4) in 2 or fewer locations by fusion & standard 12 core biopsy
  -  If 2 standard biopsy cores are positive, they must be from similar sextant location in the prostate as the MR or fusion-identified lesion that was biopsied and proven to be cancer. In other words, tumors must be visible on MR, with no clandestine tumor found by standard 12 core biopsy that could not be accounted for by visible positive MRI or fusion-defined targets.
  -  Targeted tumors must be >5mm from urethra, rectal wall, or neurovascular bundle.
  -  Must have had a prostate MRI performed at the NIH within 6 months prior to ablation.
  -  No evidence of metastatic disease work per NCCN guidelines version 1.2016 Prostate Cancer
  -  Bone scan indicated to r/o metastatic disease if [clinical T1 and PSA > 20 or T2 and PSA > 10, Gleason score>8, T3 or T4 tumors, symptomatic disease]
  -  PSA < 15 ng/ml, or PSA density (PSA/prostate volume) < 0.15 ng/mL2 in patients with a PSA > 15 ng/mL
  -  Men >18 years of age.
  -  ECOG performance status less than or equal to 2 (Karnofsky >60%).
  -  Patients must have normal organ and marrow function as defined below:
  -  leukocytes >3,000/mcL
  -  absolute neutrophil count >1,500/mcL
  -  platelets >100,000/mcL
  -  total bilirubin within normal institutional limits
  -  AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
  -  creatinine within normal institutional limits
  OR
  -  creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
  -  Preoperative clearance by NIH Department of Anesthesia and Surgical Services
  -  Ability of subject to understand and the willingness to sign a written informed consent document.
  -  Subject understands that this is an experimental treatment and that there are available standard treatment options. These options would include but not be limited to: active surveillance, external beam radiation and brachytherapy, androgen deprivation therapy, focal cryoablation, or prostatectomy.
  EXCLUSION CRITERIA:
  -  Presence of 3 or more distinct MR visible lesions that is also positive on biopsy, or presence of multi-focal disease in 3 or more sextants, regardless of MRI visibility.
  -  Presence of extra capsular, seminal vesical invasion or metastatic disease per NCCN guidelines. Bone scan indicated to rule out metastatic disease if [clinical T1 and PSA > 20 or T2 and PSA > 10] .
  -  Patient unable to commit to follow up.
  -  History of prior treatment for prostate cancer.
  -  Acute urinary tract infection.
  -  Patients with uncontrolled coagulopathies.
  -  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, that would preclude study completion or increase risks of local therapies above an acceptable level.
  -  Inability to undergo a contrast enhanced MRI per American College of Radiology and the Clinical Center, Department of Radiology guidelines.
  -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Relevance to patient case: not relevant