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

About This Trial

This study is testing a targeted treatment using high-intensity sound waves to destroy only the tumor, rather than treating the whole prostate gland.
It is open to men between 55 and 80 years old who have medium-risk prostate cancer that is visible on an MRI scan and has not spread.
The main goal is to see if treating just the cancer spot, combined with close monitoring, can safely delay or prevent the need for major surgery or radiation while lowering the risk of urinary and sexual side effects.
Before considering this study, you should know that you must be able to have regular MRI scans and cannot have had prior prostate cancer treatments, such as radiation or recent hormone therapy.

More Information

PSA (Prostate-specific antigen) testing has significantly increased the number of men diagnosed with prostate cancer (PCa) and especially patients with low and intermediate risk disease.
The effect of radical treatment (treatment of the entire prostate gland) in these risk groups is disputable while the risk of adverse effects, with erectile dysfunction and urinary incontinence, is not.
Active surveillance (AS) has been developed as an alternative to radical treatment with the aim of avoiding or delaying radical treatment by closely monitoring for signs of tumor progression.
Active surveillance is regarded as the treatment of choice for low-risk prostate cancer.
Focal therapy may have a crucial role in improving active surveillance protocols for patients with intermediate localized prostate cancer.
Focal eradication of the index-tumor may delay or avoid indefinitely radical treatment for this patient group while significantly reducing treatment-related side effects.
Improved MRI-diagnostics and MRI/ ultrasound fusion technology have optimized tumor mapping and classification and this in turn has made partial treatment of the prostate a feasible treatment option.
This study is a prospective cohort study.
Patients with intermediate (high-risk) localized PCa and a visible index tumor will be treated with high-intensity focused ultrasound (HIFU).
The aim of the study is to show that there is a significant effect of focal treatment on surveillance biopsies and a reduced conversion to radical treatment, without compromising survival outcomes compared to historical controls (retrospective cohort).
A cohort from the more than 450 patients included in the local AS-protocol with MRI at Vestfold hospital trust since 2009 will serve as controls.

Who Can Enroll

Age Range: 18 - 80 years
Gender: Male
Who This Trial is For: This study is testing a targeted treatment using high-intensity sound waves to destroy only the tumor, rather than treating the whole prostate gland.

Study Details

Start Date: September 1, 2020
Lead Sponsor: The Hospital of Vestfold

Full 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 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 5% chance of lymph node metastases calculated by the updated prostate cancer staging nomogram (Partin tables) (30)
Radiological imaging:
PI-RADS score 2 MRI detected tumors validated by systematic or MRI-guided biopsies
Contraindications for MRI