A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer

Titre officiel

Customized Ablation of the Prostate With the TULSA Procedure Against Radical Prostatectomy Treatment: a Randomized Controlled Trial for Localized Prostate Cancer (CAPTAIN)

Sommaire:

Les hommes atteints d’un cancer de la prostate localisé à risque intermédiaire seront répartis aléatoirement pour subir soit une prostatectomie radicale, soit le protocole TULSA, et seront suivis pendant 10 ans dans le cadre de l’essai de contrôle multicentrique avec répartition aléatoire. Cette étude permettra de déterminer si le protocole TULSA est aussi efficace, voire plus sûr, que la prostatectomie radicale.

Description de l'essai

Primary Outcome:

• Safety endpoint - proportion of patients who maintain both urinary continence and erectile potency
• Efficacy endpoint - proportion of patients free from treatment failure

• Biochemical failure endpoint
• Histological failure endpoint
• mpMRI endpoint (for Tulsa arm only)
• Salvage-free survival endpoint
• Metastases-free survival endpoint
• Prostate cancer-specific survival endpoint
• Overall survival endpoint
• Surgical complications endpoint
• Penile rehabilitation endpoint
• Penile length endpoint
• Blood loss endpoint
• Transfusion volume endpoint
• inpatient hospital stay endpoint
• IIEF-15 Endpoint
• IPSS Endpoint
• EPIC Endpoint
• NRS Endpoint
• EQ-5D-5L Endpoint

The typical standard of care for patients with localized, intermediate risk prostate cancer is radical prostatectomy, which involves the surgical removal of the prostate. Although radical prostatectomy is effective in terms of controlling the cancer, it may leave men with significant long-term effects in urinary, sexual function like erectile dysfunction and/or incontinence (loss of bladder control), thus reducing quality of life. Preservation of continence (ability to control your bladder) and potency (ability to achieve erection and/or ejaculation) may be significant concerns for men.

Targeted ablation of localized prostate cancer using MRI-guided technology is becoming a favorable option for many men who wish to have their cancer treated but do not wish to compromise their urinary and sexual functions. The TULSA Procedure is a new, minimally-invasive technique that uses real-time MRI-guided technology to guide the delivery of high-energy ultrasound to precisely, and in a customized fashion specific to you, heat and kill the prostate cancer tissue while protecting important surrounding body parts that are important for preserving urinary and sexual function. Minimally invasive here means that the procedure is performed through natural openings in your body (the urethra) instead of creating larger openings like traditional surgery or minimally invasive surgery.

The purpose of this research study is to:

• Test whether the TULSA Study Procedure preserves or improves your quality of life (urinary, bowel and sexual functions) at 12 months post-study treatment compared to standard of care (radical prostatectomy).
• Test how many subjects who undergo the TULSA Study Procedure are free from treatment failure by 3 years post-study treatment compared to subjects who undergo the standard of care (radical prostatectomy). Treatment failure is defined as undergoing other additional prostate cancer treatments, spreading of cancer or death caused by cancer.

About 201 subjects will participate in this study with 67 randomly assigned to the radical prostatectomy group and 134 randomly assigned to the TULSA procedure group. Patients will have a 1 in 3 chance of being assigned to the radical prostatectomy group and a 2 in 3 chance of being assigned to the TULSA group. Following treatment, patients will be followed up for 10 years.

Voir cet essai sur ClinicalTrials.gov