High-intensity Focused Ultrasound for Localized Prostate Cancer
Active Surveillance Plus (AS+): Local Tumor Control With High-intensity Focused Ultrasound (HIFU) in Patients With Localized Prostate Cancer
This study is testing if high-intensity focused ultrasound can safely treat localized prostate cancer while reducing the need for more aggressive treatments and their side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | The Hospital of Vestfold Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Tønsberg, Vestfold) |
| Trial ID | NCT04549688 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of high-intensity focused ultrasound (HIFU) as a focal treatment for patients with localized, intermediate-risk prostate cancer, followed by active surveillance. The aim is to determine if this approach can effectively control the tumor while minimizing the need for radical treatment and reducing associated side effects. By closely monitoring patients with MRI, the study seeks to establish HIFU as a safe and effective alternative for managing prostate cancer in selected individuals. The research addresses an unmet need for better treatment options that balance efficacy and quality of life.
Who should consider this trial
Good fit: Ideal candidates are men aged 55-80 with localized, intermediate-risk prostate cancer and a life expectancy of more than 10 years.
Not a fit: Patients with advanced prostate cancer, previous treatments, or significant risk factors for metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for prostate cancer, reducing the need for radical surgery and its associated side effects.
How similar studies have performed: While the use of focal therapies like HIFU is gaining interest, this specific approach in combination with active surveillance is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 55-80 years * Life expectancy \>10 years * Gleason-score: * patients \<75 years: Gleason score \< 8 * patients 75-80 years: Gleason \<9 * TNM-stage: clinical/ radiological stage \<T2c (localized), rN0 and rM0 * PSA \< 15 * PSA \> 15 should be counseled with caution (does not apply to patients \>75 years) * Risk group: d'Amico intermediary risk group, open for high risk patients age \>75 years Exclusion Criteria: * Previous treatment * Previous treatment of the primary cancer within the prostate * Previous hormone treatment for prostate cancer within 6 months before trial * Previous radiation to pelvis * Acute urinary tract infection * For patients \<75 years: \>5% chance of lymph node metastases calculated by the updated prostate cancer staging nomogram (Partin tables) (30) * Radiological imaging: * PI-RADS score \<3, clinical significant cancer is equivocal * Extracapsular extension or seminal vesicle invasion * Lymph node or bone metastasis * \> 2 MRI detected tumors validated by systematic or MRI-guided biopsies * Contraindications for MRI
Where this trial is running
Tønsberg, Vestfold
- Vestfold Hospital Trust (Hospital of Vestfold) — Tønsberg, Vestfold, Norway (Recruiting)
Study contacts
- Principal investigator: Sven Löffeler — The Hospital of Vestfold
- Study coordinator: Sven Löffeler, MD, PhD
- Email: sven.loffeler@siv.no
- Phone: +47-33342000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.