Active Surveillance Plus (AS+): High-intensity Focused Ultrasound (HIFU) in Patients With Localized Prostate Cancer

Launched by THE HOSPITAL OF VESTFOLD · Sep 9, 2020

Keywords

ClinConnect Summary

This clinical trial, called Active Surveillance Plus (AS+), is exploring a new treatment approach for men with localized prostate cancer, particularly those with intermediate risk. The study is looking at a technique called high-intensity focused ultrasound (HIFU), which targets and treats specific areas of the prostate while allowing for close monitoring of the cancer. This method aims to delay or even avoid the need for more extensive treatments, which can come with significant side effects like erectile dysfunction and urinary problems.

To participate in the trial, men aged 55 to 80 with specific prostate cancer characteristics may be eligible. Key criteria include having a Gleason score of less than 8 for those under 75 and less than 9 for those aged 75-80, as well as a PSA level of less than 15. Participants can expect to receive focused ultrasound treatment and be monitored closely for any changes in their condition. This study is important because it hopes to show that this targeted approach can lead to better outcomes without compromising survival, providing a promising alternative for men facing prostate cancer.

Gender

MALE

Eligibility 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