NCT04549688Recruiting
Active Surveillance Plus (AS+): High-intensity Focused Ultrasound (HIFU) in Patients With Localized Prostate Cancer
Active Surveillance Plus (AS+): Local Tumor Control With High-intensity Focused Ultrasound (HIFU) in Patients With Localized Prostate Cancer
Source: ClinicalTrials.gov · Last updated 22 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 9 Sept 2020
- Start date
- 1 Sept 2020
- Primary completion date
- 30 Sept 2030
- Lead sponsor
- The Hospital of Vestfold
- Diseases
- Prostate cancer
- NCT number
- NCT04549688
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 1 Sept 2020 to the primary completion date, 30 Sept 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Acute urinary tract infection
- PI-RADS score \<3, clinical significant cancer is equivocal
Age
- For patients \<75 years: \>5% chance of lymph node metastases calculated by the updated prostate cancer staging nomogram (Partin tables) (30)
Other
- Radiological imaging:
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vestfold Hospital Trust (Hospital of Vestfold) Coordinator of this site? Confirm its status | Tønsberg | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.