What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as high-intensity focused ultrasound (HIFU) and radical prostatectomy, have notable side effects. HIFU, similar to the TULSA procedure, can cause urinary tract infections, urinary incontinence, erectile dysfunction, and urinary retention. Radical prostatectomy may lead to urinary incontinence, erectile dysfunction, bleeding, infection, and injury to surrounding organs. These side effects highlight the importance of discussing treatment options thoroughly with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including surgical options, radiation therapies, and various drug therapies. While specific FDA approvals for treatments exactly like the TULSA procedure (Transurethral Ultrasound Ablation) are not detailed, other minimally invasive treatments such as High-Intensity Focused Ultrasound (HIFU) have been explored. Additionally, drugs like abiraterone, enzalutamide, and apalutamide, which target androgen receptor signaling pathways, have been approved for advanced stages of prostate cancer. These treatments aim to manage the disease by reducing androgen levels or blocking androgen receptors, thereby inhibiting cancer growth.

What other types of research exist?

Promising novel alternatives to the TULSA procedure for prostate cancer treatment include: 1) MRI-guided focal laser ablation, which uses laser energy to precisely target and destroy cancerous tissue; 2) High-Intensity Focused Ultrasound (HIFU), which uses focused ultrasound waves to heat and destroy cancer cells; 3) Cryotherapy, which involves freezing cancer cells to kill them; and 4) Stereotactic Body Radiotherapy (SBRT), a form of radiation therapy that delivers highly targeted radiation doses to the tumor while minimizing damage to surrounding tissues. These treatments are being evaluated for their effectiveness and safety in clinical trials and may offer viable options for patients in 2024.

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Procedure

TULSA Procedure vs. Radical Prostatectomy for Prostate Cancer (CAPTAIN Trial)

N/A

Recruiting

Research Sponsored by Profound Medical Inc.

Eligibility Criteria Checklist

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

Must have

Male

Biopsy-confirmed, NCCN (favorable and unfavourable) intermediate-risk prostate acquired within last 12 months

Timeline

Screening 3 days

Treatment Varies

Follow Up 120 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares a new treatment with traditional surgery in men with prostate cancer. The goal is to see if the new treatment can effectively treat cancer while preserving important functions better than surgery. Patients will be followed for several years to assess outcomes. The new treatment is minimally invasive and uses advanced technology to target prostate tissue.

Who is the study for?

Men aged 40-80 with intermediate-risk, localized prostate cancer (Stage ≤T2c, N0, M0) and a life expectancy of over 10 years. Participants must have had a recent biopsy confirming the condition and not undergone any previous treatments for it. Those with certain urinary or anal implants, history of fibrosis or stenosis challenging device insertion, inability to undergo MRI/general anesthesia, or severe bladder conditions cannot join.

What is being tested?

This study is comparing two procedures in men with prostate cancer: radical prostatectomy (surgery to remove the entire prostate gland) versus TULSA procedure (a less invasive technique using ultrasound). Patients will be randomly assigned to one of these treatments and followed up for 10 years to assess effectiveness and safety.

What are the potential side effects?

Radical prostatectomy can cause urinary incontinence, erectile dysfunction, pain and bleeding post-surgery. The TULSA procedure may result in similar side effects but is expected to be safer; specific side effects will be studied.

Eligibility Criteria

Inclusion Criteria

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

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I am male.

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My prostate cancer is intermediate-risk, confirmed by a biopsy in the last year.

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My cancer is in an early stage and has not spread to lymph nodes or other parts of my body.

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My prostate cancer is classified as ISUP Grade Group 2 or 3.

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I have not received any treatment for my condition.

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My treatment area near the urethra is less than 3 cm, confirmed by a recent MRI.

Timeline

Screening ~ 3 days3 visits

Treatment ~ Varies

Follow Up ~ 120 months5 visits

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~120 months

This trial's timeline: 3 days for screening, Varies for treatment, and 120 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Efficacy endpoint - proportion of patients free from treatment failure

Safety endpoint - proportion of patients who maintain both urinary continence and erectile potency

Secondary study objectives

Biochemical failure endpoint

Blood loss endpoint

EPIC Endpoint

+15 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TULSA ProcedureExperimental Treatment1 Intervention

Patients in this group will undergo TULSA Procedure. There will be about 134 people in this group.

Group II: Radical ProstatectomyActive Control1 Intervention

Patients in this group will undergo Radical prostatectomy. There will be about 67 people in this group.

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

The TULSA procedure uses high-intensity ultrasound waves to ablate prostate tissue, effectively destroying cancerous cells through thermal energy. This method is minimally invasive and aims to preserve surrounding healthy tissue. Other common treatments include radical prostatectomy, which surgically removes the prostate gland, and androgen deprivation therapy (ADT), which lowers male hormone levels to slow cancer growth. Understanding these mechanisms helps patients make informed decisions about their treatment options, considering factors like effectiveness, safety, and potential side effects.

Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation.[Local treatment of prostate cancer using thermal-ablative energy].