What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly ablative techniques like MRI-guided focal laser ablation (LITT), cryotherapy, and high-intensity focused ultrasound (HIFU), can have side effects such as urinary symptoms (frequency, urgency, retention), erectile dysfunction, infection, bleeding, and damage to surrounding tissues. LITT specifically may cause localized pain, swelling, and potential damage to adjacent structures due to the precision required in laser application.

What prior FDA approvals exist?

The FDA has approved various treatments for prostate cancer, including those that involve ablation techniques. One such method is MRI-guided focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT), which uses laser-generated heat to ablate cancer tissue. While specific FDA approvals for LITT in prostate cancer are not detailed, similar thermal ablation techniques have been explored and utilized in clinical settings. These methods offer a minimally invasive option for targeting and destroying cancerous tissues, providing an alternative to more traditional surgical approaches.

What other types of research exist?

Promising novel alternatives to MRI-guided focal laser ablation (LITT) for prostate cancer patients include: 1) Transurethral Holmium Laser Enucleation of the Prostate (HoLEP), which is effective for benign prostatic hyperplasia and may have applications in cancer treatment. 2) Thulium Laser Enucleation, which offers precise tissue removal with minimal bleeding. 3) Aquablation, a waterjet-based technique that provides a minimally invasive option with promising outcomes. 4) Prostatic Urethral Lift (PUL), which is less invasive and has shown good results in symptom relief and quality of life improvement.

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Procedure

Focal Laser Ablation for Prostate Cancer

N/A

Waitlist Available

Led By David Woodrum, MD, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of prostate adenocarcinoma.

Male, 45 years of age or older.

Must not have

History of other primary non-skin malignancy within previous three years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a laser treatment guided by MRI to target and destroy cancer cells in patients with low-risk prostate cancer. The laser heats up and kills the cancer cells in a precise area, making it a less invasive option compared to surgery or radiotherapy.

Who is the study for?

Men over 45 with low to intermediate-risk prostate cancer can join this trial. They should have a PSA level of 20 ng/mL or less, a Gleason score up to 7, and no more than three small cancer spots on their prostate that match MRI scans. Participants need to be able to handle anesthesia and give informed consent.

What is being tested?

The study is testing the safety and effectiveness of using MRI-guided laser heat (LITT) for treating small areas of cancer in the prostate without affecting the rest of it.

What are the potential side effects?

Possible side effects may include discomfort or pain at the treatment site, swelling, urinary issues like difficulty or increased frequency, and risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with prostate cancer.

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I am a man aged 45 or older.

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My breast cancer is in an early stage, but larger than 2 cm.

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My prostate cancer is found in 3 or fewer spots, matching my MRI results.

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My prostate cancer has a Gleason score of 7 or is intermediate risk Gleason 6.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer other than skin cancer in the last 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of treatment emergent adverse events

Success rate

Secondary study objectives

Short- and mid-term ablative success

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single arm studyExperimental Treatment1 Intervention

MR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments often aim to target and destroy cancerous tissues while preserving surrounding healthy tissues. MRI-guided focal laser ablation (LITT) uses laser-generated heat to precisely ablate cancer cells, minimizing damage to adjacent tissues. This method is particularly beneficial for patients with localized tumors, as it offers a minimally invasive option with potentially fewer side effects compared to traditional surgery. Other common treatments include androgen deprivation therapy (ADT), which reduces testosterone levels to slow cancer growth, and radiation therapy, which uses high-energy rays to kill cancer cells. These treatments are crucial for managing prostate cancer, as they can improve survival rates, reduce symptoms, and enhance the quality of life for patients.