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Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TULSA-PRO

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring TULSA, Thermal Therapy System, PSA, Gleason Score

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

INCLUSION CRITERIA:

Subjects must have prostate cancer, amenable for ultrasound ablation defined as following:

diagnosed by prostate biopsies consist of transrectal ultrasound-guided standard 12 core biopsy and biopsies of one or two MRI target lesions;
Gleason Score <= 7;
<= 4 cores positive in a standard 12 core biopsy and <= 4 cores positive on MRI target lesions biopsy where 2 cores are taken from each of the one or two MRI target lesions;
histologically positive standard biopsy cores must be from the same location in the prostate as an MRI target lesion(s) and reviewed by NCI urologic pathologist. (Left / Right, Base, Mid-Gland, Apex).
organ confined clinical T1c or clinical T2a prostate cancer that is visualized on MRI imaging. Note: Participants after prostate cancer treatment with local recurrence or residual tumor which is visible on MRI are eligible.
PSA < 20 ng/ml.
Adults (>= 18 years of age)
Participants must have adequate organ and marrow function as defined below:

Platelets >= 50,000/mcL

Hemoglobin >= 8 g/dL

ALT or AST <= 5 x ULN

Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)* >= 30 mL/min/1.73 m^2

ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.

*Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.

- Subjects must be able to understand and willing to sign a written informed consent document.

EXCLUSION CRITERIA:

The presence of 3 or more MRI visible lesions positive for prostate cancer on biopsy
Targeted lesion ablation length from apex to base of >5 cm or lesion extending >3 cm from the urethra.
Target ablative volume of greater than 100 ml.
Presence of calcifications that would impede ultrasound transmission between the urethra and ablative target.
The participant is unable to tolerate MRI (foreign body, i.e., pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil; etc.)
The participant with the inability to follow up
Acute urinary tract infection
Lower urinary tract symptoms defined by an IPSS > 20
Participants with uncontrolled coagulopathies (including liver dysfunction, or untreated hereditary coagulopathies which have a standard of care treatment) per surgeon discretion based on bleeding risk.
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.

Sites / Locations

National Institutes of Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1/Arm 1

Arm Description

Ultrasound ablation of focal prostate cancer

Outcomes

Primary Outcome Measures

feasibility and tolerability

To determine the feasibility of magnetic resonance image (MRI)-guided ultrasound-induced thermal therapy of biopsy-confirmed and MRI visible, prostate tumor(s) using the TULSA Thermal Therapy System (Profound Medical)

Secondary Outcome Measures

safety and tolerability

Address short- and long-term complication rates of study treatment by tabulating adverse events by grade according to CTCAE, and analyzing and reporting descriptively

changes in imaging and biopsy characteristics

Determine if focal ablation of MRI visible, biopsy-confirmed prostate cancer using the TULSA Thermal Therapy System (Profound Medical) platform can successfully ablate targeted prostate cancer lesions in >50% of participants

effect of thermal ablation on short- and long-term complication rates

Observe thermal damage on post-contrast MRI which extends into areas of the Rectum or Urethra; assess frequency of not completing the procedure

thermal damage

Observe thermal damage on post-contrast MRI which extends into areas of the Rectum or Urethra; assess frequency of not completing the procedure

outcome of TULSA ablation

Use descriptive statistical analysis to examine serial PSA, PSA density, changes in imaging and biopsy, International Prostate Symptom Score (IPSS), and Sexual Health Inventory for Men (SHIM)

Full Information

NCT ID

NCT04808427

First Posted

March 19, 2021

Last Updated

October 24, 2023

Sponsor

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04808427

Brief Title

Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer

Official Title

Magnetic Resonance Image (MRI) Guided High Energy Ultrasound for Focal Prostate Cancer Ablation

Study Type

Interventional

2. Study Status

Record Verification Date

August 15, 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 30, 2023 (Anticipated)

Primary Completion Date

May 1, 2027 (Anticipated)

Study Completion Date

September 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

Brief Summary

Background: The ability to treat early prostate cancer is still limited. Thermal ablation methods are being tested for focal prostate cancer therapy. Researchers want to improve on these methods. Objective: To understand if Transurethral UltraSound Ablation (TULSA) in combination with MRI guidance is useful to treat localized prostate cancer. Eligibility: English-speaking adults ages 18 and older with localized prostate cancer that can be seen on MRI and can be treated by thermal ablation. Design: Participants will be screened with the following: Medical history Physical exam Digital rectal exam Blood and urine tests Electrocardiogram Tumor biopsy Questionnaire to assess urinary tract symptoms MRI of the pelvis. The MRI scanner is a long, narrow tube. Participants will lie on a bed that moves in and out of the scanner. Participants may also be screened with the following: Echocardiogram Chest x-ray Bone scan Urodynamic studies to see how well the bladder, sphincters, and urethra hold and release urine MRI of the brain Transrectal ultrasound Computer tomography (CT) scan of the chest, abdomen, and pelvis. A CT scan is a series of x-ray images taken of parts of the body. Some screening tests will be repeated during the study. Participants will have the TULSA procedure. They will have an MRI for guidance. A small ultrasound applicator will be placed into their urethra. It uses heat to destroy the cancer areas in the prostate. It is controlled by a robotic arm. A cooling catheter will be placed into their rectum. Participants will use a urethral catheter for 1-7 days. Participants will have follow-up visits at 3, 6, 12, 18, 24, and 36 months.

Detailed Description

Background: 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 participants 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. Focal Therapy for prostate cancer has gained popularity however prior studies demonstrate a failure rate as high as 50% with a laser. Objective: To determine the feasibility of magnetic resonance image (MRI)-guided ultrasound-induced thermal therapy of biopsy-confirmed and MRI visible, prostate tumor(s) using the TULSA Thermal Therapy System (Profound Medical) Eligibility: Subjects with prostate cancer, amenable for ultrasound ablation Organ confined clinical T1c or clinical T2a prostate cancer, visible on MRI, and confirmed by prostate biopsy Adequate organ and marrow function Prostate-specific antigen (PSA) < 20 ng/ml Age >=18 years Design: Study testing feasibility and tolerability of ultrasound ablation of focal prostate cancer. It is anticipated that 15 participants will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

TULSA, Thermal Therapy System, PSA, Gleason Score

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1/Arm 1

Arm Type

Experimental

Arm Description

Ultrasound ablation of focal prostate cancer

Intervention Type

Device

Intervention Name(s)

TULSA-PRO

Intervention Description

Transurethral MR-Thermometry Guided Ultrasound Ablation of the Prostate

Primary Outcome Measure Information:

Title

feasibility and tolerability

Description

Time Frame

3, 6, 12, 18, 24, and 36 months

Secondary Outcome Measure Information:

Title

safety and tolerability

Description

Address short- and long-term complication rates of study treatment by tabulating adverse events by grade according to CTCAE, and analyzing and reporting descriptively

Time Frame

3, 6, 12, 18, 24, and 36 months

Title

changes in imaging and biopsy characteristics

Description

Time Frame

3, 6, 12, 18, 24, and 36 months

Title

effect of thermal ablation on short- and long-term complication rates

Description

Observe thermal damage on post-contrast MRI which extends into areas of the Rectum or Urethra; assess frequency of not completing the procedure

Time Frame

3, 6, 12, 18, 24, and 36 months

Title

thermal damage

Description

Observe thermal damage on post-contrast MRI which extends into areas of the Rectum or Urethra; assess frequency of not completing the procedure

Time Frame

3, 6, 12, 18, 24, and 36 months

Title

outcome of TULSA ablation

Description

Use descriptive statistical analysis to examine serial PSA, PSA density, changes in imaging and biopsy, International Prostate Symptom Score (IPSS), and Sexual Health Inventory for Men (SHIM)

Time Frame

3, 6, 12, 18, 24, and 36 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA: Subjects must have prostate cancer, amenable for ultrasound ablation defined as following: diagnosed by prostate biopsies consist of transrectal ultrasound-guided standard 12 core biopsy and biopsies of one or two MRI target lesions; Gleason Score <= 7; <= 4 cores positive in a standard 12 core biopsy and <= 4 cores positive on MRI target lesions biopsy where 2 cores are taken from each of the one or two MRI target lesions; histologically positive standard biopsy cores must be from the same location in the prostate as an MRI target lesion(s) and reviewed by NCI urologic pathologist. (Left / Right, Base, Mid-Gland, Apex). organ confined clinical T1c or clinical T2a prostate cancer that is visualized on MRI imaging. Note: Participants after prostate cancer treatment with local recurrence or residual tumor which is visible on MRI are eligible. PSA < 20 ng/ml. Adults (>= 18 years of age) Participants must have adequate organ and marrow function as defined below: Platelets >= 50,000/mcL Hemoglobin >= 8 g/dL ALT or AST <= 5 x ULN Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)* >= 30 mL/min/1.73 m^2 ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal. *Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard. - Subjects must be able to understand and willing to sign a written informed consent document. EXCLUSION CRITERIA: The presence of 3 or more MRI visible lesions positive for prostate cancer on biopsy Targeted lesion ablation length from apex to base of >5 cm or lesion extending >3 cm from the urethra. Target ablative volume of greater than 100 ml. Presence of calcifications that would impede ultrasound transmission between the urethra and ablative target. The participant is unable to tolerate MRI (foreign body, i.e., pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil; etc.) The participant with the inability to follow up Acute urinary tract infection Lower urinary tract symptoms defined by an IPSS > 20 Participants with uncontrolled coagulopathies (including liver dysfunction, or untreated hereditary coagulopathies which have a standard of care treatment) per surgeon discretion based on bleeding risk. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michele L Reed, R.N.

Phone

(240) 760-6121

michele.reed@nih.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Peter A Pinto, M.D.

Phone

(240) 858-3700

pp173u@nih.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter A Pinto, M.D.

Organizational Affiliation

National Cancer Institute (NCI)

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institutes of Health Clinical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Phone

888-624-1937

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

.All IPD recorded in the medical record will be shared with intramural investigators upon request

IPD Sharing Time Frame

Clinical data available during the study and indefinitely.

IPD Sharing Access Criteria

Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Links:

URL

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2021-C-0017.html

Description

NIH Clinical Center Detailed Web Page

Learn more about this trial

Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer

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