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

RecruitingNAAges 18 Years - 80 YearsMaleThe Hospital of Vestfold
NCT04549688 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • high-intensity focused ultrasound, HIFU
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Where

1 site
Vestfold Hospital Trust (Hospital of Vestfold)
Tønsberg, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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