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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04549688
Recruitment Status : Recruiting
First Posted : September 15, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Sven Löffeler, The Hospital of Vestfold

Brief 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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: high-intensity focused ultrasound, HIFU Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Focal therapy Procedure: high-intensity focused ultrasound, HIFU
see above




Primary Outcome Measures :
  1. 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

  2. Measurement of functional results [ Time Frame: 1-10 years ]
    erectile function, continence, and other therapy-related complications. Questionnaire-based.

  3. Number of patients who need repeated focal treatment [ Time Frame: 1-10 years ]
    recurrence and recurrent treatment

  4. Number of patients eligible for continuous AS+ [ Time Frame: 1-10 years ]
  5. Disease-free survival [ Time Frame: 1-10 years ]
    based on repeated MRI and repeat biopsies performed on clinical/ radiological suspicion

  6. Treatment-free survival [ Time Frame: 1-10 years ]
  7. Overall survival [ Time Frame: 1-10 years ]
  8. Metastasis-free survival [ Time Frame: 1-10 years ]
  9. Number of patients who need radical (surgery or radiation), or palliative treatment (hormone therapy) [ Time Frame: 1-10 years ]

Secondary Outcome Measures :
  1. Number of patients where MRI predicted tumor recurrence/ tumor absence [ Time Frame: 1-10 years ]
    MRI findings verified by biopsies

  2. Patient Reported Outcomes Measures [ Time Frame: 1-10 years ]
    Survey-based using standard questionaires



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male prostate cancer patients
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Sven Löffeler, MD, PhD +47-33342000 ext +4733342000 sven.loffeler@siv.no
Contact: Sven Löffeler +4733342000 ext +4733342000 sven.loffeler@siv.no

Locations
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Norway
Vestfold Hospital Trust (Hospital of Vestfold) Recruiting
Tønsberg, Vestfold, Norway, 3103
Contact: Sven Löffeler    +4733342000 ext +4733342000    sven.loffeler@siv.no   
Sponsors and Collaborators
The Hospital of Vestfold
Investigators
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Principal Investigator: Sven Löffeler The Hospital of Vestfold
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Responsible Party: Sven Löffeler, Principal Investigator, The Hospital of Vestfold
ClinicalTrials.gov Identifier: NCT04549688    
Other Study ID Numbers: AS-plus-SiV-01
First Posted: September 15, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sven Löffeler, The Hospital of Vestfold:
prostate cancer
HIFU
focal treatment
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases