Active Surveillance Plus (AS+): High-intensity Focused Ultrasound (HIFU) in Patients With Localized Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04549688|
Recruitment Status : Recruiting
First Posted : September 15, 2020
Last Update Posted : September 16, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: high-intensity focused ultrasound, HIFU||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||prospective, single-arm, case-control cohort study with consecutive patients with intermediate-risk, MRI-visible prostate cancer treated focally with HIFU. Study patients will be compared to historical controls (patients observed with AS at SiV 2009-2017).|
|Masking:||None (Open Label)|
|Official Title:||Active Surveillance Plus (AS+): Local Tumor Control With High-intensity Focused Ultrasound (HIFU) in Patients With Localized Prostate Cancer|
|Actual Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||September 2030|
|Estimated Study Completion Date :||September 2030|
|Experimental: Focal therapy||
Procedure: high-intensity focused ultrasound, HIFU
- Number of patients without clinically significant prostate cancer [ Time Frame: 1-10 years ]Absence of clinically significant prostate cancer (Gleason grade ≥7A) on post-treatment systematic and targeted biopsies
- Measurement of functional results [ Time Frame: 1-10 years ]erectile function, continence, and other therapy-related complications. Questionnaire-based.
- Number of patients who need repeated focal treatment [ Time Frame: 1-10 years ]recurrence and recurrent treatment
- Number of patients eligible for continuous AS+ [ Time Frame: 1-10 years ]
- Disease-free survival [ Time Frame: 1-10 years ]based on repeated MRI and repeat biopsies performed on clinical/ radiological suspicion
- Treatment-free survival [ Time Frame: 1-10 years ]
- Overall survival [ Time Frame: 1-10 years ]
- Metastasis-free survival [ Time Frame: 1-10 years ]
- Number of patients who need radical (surgery or radiation), or palliative treatment (hormone therapy) [ Time Frame: 1-10 years ]
- Number of patients where MRI predicted tumor recurrence/ tumor absence [ Time Frame: 1-10 years ]MRI findings verified by biopsies
- Patient Reported Outcomes Measures [ Time Frame: 1-10 years ]Survey-based using standard questionaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04549688
|Contact: Sven Löffeler, MD, PhD||+47-33342000 ext +firstname.lastname@example.org|
|Contact: Sven Löffeler||+4733342000 ext +email@example.com|
|Vestfold Hospital Trust (Hospital of Vestfold)||Recruiting|
|Tønsberg, Vestfold, Norway, 3103|
|Contact: Sven Löffeler +4733342000 ext +4733342000 firstname.lastname@example.org|
|Principal Investigator:||Sven Löffeler||The Hospital of Vestfold|