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

Condition(s) studied

Investigational drug(s) / intervention(s)

high-intensity focused ultrasound, HIFU: see above

Study summary

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.

Eligibility

Primary outcome measure(s)

• Number of patients without clinically significant prostate cancer — 1-10 years
  Absence of clinically significant prostate cancer (Gleason grade ≥7A) on post-treatment systematic and targeted biopsies
• Measurement of functional results — 1-10 years
  erectile function, continence, and other therapy-related complications. Questionnaire-based.
• Number of patients who need repeated focal treatment — 1-10 years
  recurrence and recurrent treatment
• Number of patients eligible for continuous AS+ — 1-10 years
• Disease-free survival — 1-10 years
  based on repeated MRI and repeat biopsies performed on clinical/ radiological suspicion
• Treatment-free survival — 1-10 years
• Overall survival — 1-10 years
• Metastasis-free survival — 1-10 years
• Number of patients who need radical (surgery or radiation), or palliative treatment (hormone therapy) — 1-10 years

Trial sites (1)

More The Hospital of Vestfold trials in Norway

Other trials for the same condition