Clinical trial NCT01377753: MR Image Guided Therapy in Prostate Cancer
Official title: MR Image Guided Focal Therapy in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Prostatic Neoplasms
Keywords: Toxicity
Thermal Ablation/Damage
Localized Prostate Cancer
Laser Ablation
PSA Levels
Prostate Cancer
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2011-06-21
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background:

- One way to treat prostate cancer is to use a laser to direct extreme heat to a small area of the prostate. The heat destroys tumor cells but does not affect healthy tissue. Doctors want to see if magnetic resonance imaging (MRI) can be used to improve this treatment. MRI will be used to help locate tumor cells and guide the laser during surgery. However, MRI-guided laser therapy has not been used to treat many people with prostate cancer. More studies are needed to see whether it can destroy tumor cells permanently.

Objectives:

- To test the safety and effectiveness of treating prostate tumors with laser therapy guided by magnetic resonance imaging.

Eligibility:

- Men at least 18 years of age who have prostate cancer that can be seen with an MRI and has not spread to other parts of the body.

Design:

* Participants will be screened with a physical exam and medical history. They will also have blood tests and imaging studies, and will complete questionnaires about their health.
* Participants will have the MRI-guided laser treatment in the hospital. The doctor will use the MRI to control how much energy is delivered by the laser and how much tissue is destroyed. The entire procedure usually takes from 1.5 to 3 hours.
* After the treatment, participants will have a catheter put in to keep the bladder emptied. The catheter will stay in for 1 to 7 days. Drugs to prevent infection and bladder spasms will be given. Participants will leave the hospital once they are well enough to go home.
* Participants will have follow-up visits 3, 6, 9, 12, 18, 24, and 36 months after the therapy. They will have physical exams, and blood and urine tests. They will also answer questionnaires. Participants will have MRI scans 6, 12, 24, and 36 months after the therapy. They will have a prostate biopsy to see if there is any tumor every 12 months for the first 2 years. Another biopsy may be done in the third year.

Detailed description: 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 magnetic resonance (MR) visible prostate cancer.

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 National Comprehensive Cancer Network (NCCN).org prostate cancer guidelines
* Prostate-specific antigen (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

Eligibility criteria: * INCLUSION CRITERIA:
* Men greater than 18 years of age
* Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on magnetic resonance (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 magnetic resonance imaging (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 National Comprehensive Cancer Network (NCCN) guidelines (www.nccn.org). Bone scan indicated to r/o metastatic disease if \[clinical T1 and prostate-specific antigen (PSA) \> 20 or T2 and PSA \> 10\]
* 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 Principal Investigator (PI): involving the cardiac, respiratory, central nervous system (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)

Primary outcomes:
measure: Number of Participants With One Grade 1 Adverse Event, More Than One Grade 1 Adverse Event, and One Grade 2 Adverse Event
timeFrame: For all participants enrolled over the time frame of the study including follow up time is approximately 65 months
Secondary outcomes:
measure: Mean Change in Prostate Specific Antigen (PSA) From Baseline Prior to Salvage Treatment or at the Conclusion of the Study Time Frame if There Was No Salvage Treatment
timeFrame: From date participant is enrolled to completion of post-ablation monitoring, approximately 3 years.
measure: Mean Change in Prostate Specific Antigen Density (PSAD) From Baseline During Study Time Frame
timeFrame: From date participant is enrolled to completion of post-ablation monitoring, approximately 3 years.
measure: Mean Change in Quality of Life (QoL) From Baseline Prior to Salvage Treatment or at the Conclusion of the Study Time Frame if There Was No Salvage Treatment
timeFrame: From date participant is enrolled to completion of post-ablation monitoring, approximately 3 years.
measure: Mean Change in International Prostate Symptom Score (IPSS) From Baseline Over Follow-Up Visits Prior to Salvage Treatment or Across All Follow-up Visits During Study Time Frame if There Was No Salvage Treatment
timeFrame: From date participant is enrolled to completion of post-ablation monitoring, approximately 3 years.
measure: Mean Change in Sexual Health Inventory for Men (SHIM) From Baseline Over Follow-Up Visits Prior to Salvage Treatment or Across All Follow-up Visits During Study Time Frame if There Was No Salvage Treatment
timeFrame: From date participant is enrolled to completion of post-ablation monitoring, approximately 3 years.
Other outcomes:
measure: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
timeFrame: For all participants enrolled over the time frame of the study including follow up time is approximately 65 months
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Peter A Pinto, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Mehralivand S, George AK, Hoang AN, Rais-Bahrami S, Rastinehad AR, Lebastchi AH, Ahdoot M, Siddiqui MM, Bloom J, Sidana A, Merino MJ, Choyke PL, Shih JH, Turkbey B, Wood BJ, Pinto PA. MRI-guided focal laser ablation of prostate cancer: a prospective single-arm, single-center trial with 3 years of follow-up. Diagn Interv Radiol. 2021 May;27(3):394-400. doi: 10.5152/dir.2021.20095.