MR-Guided Focal Therapy for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Overseen byPeter A Pinto, M.D.
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: National Cancer Institute (NCI)
Disqualifiers: Uncontrolled coagulopathies, Congestive heart failure, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment TULSA-PRO for prostate cancer?
Research shows that TULSA-PRO, a treatment using ultrasound guided by MRI, was effective in reducing prostate cancer in most patients, with 8 out of 9 showing significant improvement and no major side effects. This suggests it could be a safe and effective option for treating localized prostate cancer.
12345Is MR-Guided Focal Therapy for Prostate Cancer safe for humans?
Research shows that MR-Guided Focal Therapy, also known as TULSA, appears to be safe for treating prostate cancer, with no major urinary or gastrointestinal side effects and no changes in erectile firmness observed in patients.
13567How is the TULSA-PRO treatment different from other prostate cancer treatments?
TULSA-PRO is unique because it uses MRI guidance to precisely target and heat prostate tissue, allowing for focused treatment of cancerous areas while minimizing damage to surrounding healthy tissue. This minimally invasive approach aims to maintain quality of life by reducing side effects commonly associated with traditional treatments like surgery and radiotherapy.
12458Eligibility Criteria
This trial is for English-speaking adults aged 18+ with localized prostate cancer visible on MRI and treatable by thermal ablation. They must have a Gleason Score <= 7, PSA < 20 ng/ml, adequate organ function, and be able to consent. Exclusions include inability to undergo MRI, severe urinary symptoms (IPSS > 20), multiple cancer lesions on MRI, or serious illnesses that could affect study participation.Inclusion Criteria
Platelets >= 50,000/mcL
Subjects must be able to understand and willing to sign a written informed consent document.
My organs and bone marrow are functioning well.
+14 more
Exclusion Criteria
The area targeted for treatment in my body is larger than 100 ml.
The participant with the inability to follow up
My MRI shows 3 or more lesions positive for prostate cancer.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Multiple visits for various tests
Treatment
Participants undergo the TULSA procedure with MRI guidance for focal prostate cancer ablation
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
36 months
Follow-up visits at 3, 6, 12, 18, 24, and 36 months
Participant Groups
The study tests Transurethral UltraSound Ablation (TULSA) guided by MRI for treating localized prostate cancer. Participants will undergo TULSA where heat destroys targeted cancer areas in the prostate using an ultrasound applicator controlled by a robotic arm while being monitored via MRI.
1Treatment groups
Experimental Treatment
Group I: 1/Arm 1Experimental Treatment1 Intervention
Ultrasound ablation of focal prostate cancer
TULSA-PRO is already approved in United States for the following indications:
🇺🇸 Approved in United States as TULSA-PRO for:
- Localized prostate cancer
- Benign prostatic hyperplasia (BPH)
- Enlarged prostate
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
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Who Is Running the Clinical Trial?
National Cancer Institute (NCI)Lead Sponsor
References
MR Imaging-Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer: Preliminary Experience from a Single Center in a Prospective, Multi-Center, Single-Arm Clinical Trial. [2020]This report details a single-center experience of using magnetic resonance imaging-guided transurethral ultrasound ablation (TULSA) for whole-gland prostate treatment. Nine men with organ-confined low-to-intermediate-risk prostate cancer underwent the TULSA procedure. The primary endpoint of reduction of more than 75% was achieved in 8 of 9 patients, and all patients demonstrated a histologic benefit at 12-month biopsy. No major urinary or gastrointestinal side effects were observed, and there were no postprocedural changes in erectile firmness. These findings suggest that TULSA is potentially safe and efficacious for patients with low-to-intermediate-risk disease.
Single center retrospective analysis of fifty-two prostate cancer patients with customized MR-guided transurethral ultrasound ablation (TULSA). [2022]MR-guided transurethral ultrasound ablation (TULSA) has primarily been investigated for whole-gland prostate ablation, even though the technology is also well-suited for partial gland treatment. The objectives were to perform a clinical service evaluation of partial to whole-gland TULSA for patients with localized prostate cancer (CaP). TULSA was also evaluated as a combined therapy for a subset of patients presenting with both cancer and concurrent benign prostate hyperplasia (BPH).
First experiences using transurethral ultrasound ablation (TULSA) as a promising focal approach to treat localized prostate cancer: a monocentric study. [2023]To share our experience using transurethral ultrasound ablation (TULSA) treatment for focal therapy of localized prostate cancer (PCa).
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase 1 Clinical Trial. [2018]Magnetic resonance imaging-guided transurethral ultrasound ablation (MRI-TULSA) is a novel minimally invasive technology for ablating prostate tissue, potentially offering good disease control of localized cancer and low morbidity.
Acute and subacute prostate MRI findings after MRI-guided transurethral ultrasound ablation of prostate cancer. [2021]Magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) is an emerging method for treatment of localized prostate cancer (PCa). TULSA-related subacute MRI findings have not been previously characterized.
Magnetic resonance imaging-guided transurethral ultrasound ablation for benign prostatic hyperplasia: 12-month clinical outcomes of a phase I study. [2022]To investigate the safety and feasibility of magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) for the treatment of benign prostatic obstruction (BPO).
Magnetic resonance imaging-guided transurethral ultrasound ablation of prostate tissue in patients with localized prostate cancer: single-center evaluation of 6-month treatment safety and functional outcomes of intensified treatment parameters. [2021]To evaluate the effect of intensified treatment parameters on safety, functional outcomes, and PSA after MR-Guided Transurethral Ultrasound Ablation (TULSA) of prostatic tissue.
Evolving imaging methods of prostate cancer and the emergence of magnetic resonance imaging guided ablation techniques. [2022]Established therapies for prostate cancer (PCa), surgery and radiotherapy, treat the entire gland regardless of the location of the cancerous lesion within the prostate. Although effective, these methods include a significant risk of worsening genitourinary outcomes. Targeted image-guided cancer therapy has gained acceptance through improved PCa detection, localization, and characterization by magnetic resonance imaging (MRI). Minimally-invasive ablative techniques aim to achieve comparable oncological outcomes to radical treatment while preserving genitourinary function. Transurethral ultrasound ablation (TULSA) and next-generation transrectal high-intensity focused ultrasound (HIFU) utilize MRI guidance to thermally ablate prostate tissue under real-time MRI monitoring and active temperature feedback control. Previous trials performed by our group and others, including a large multicenter study in men with localized favorable-risk disease, have demonstrated that TULSA provides effective prostate ablation with a favorable safety profile and low impact on quality of life. Recently, MRI-guided HIFU focal therapy was also shown as a safe and effective treatment of intermediate-risk PCa. Here we review the current literature on ablative techniques in the treatment of localized PCa with a focus on TULSA and HIFU methods.