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

NCT04549688 | Recruiting

• 1 other identifier: AS-plus-SiV-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; HIFU; focal treatment

Outcome Measures

Primary Outcomes (9)

• Number of patients without clinically significant prostate cancer

  Absence of clinically significant prostate cancer (Gleason grade ≥7A) on post-treatment systematic and targeted biopsies

  1-10 years

• Measurement of functional results

  erectile function, continence, and other therapy-related complications. Questionnaire-based.

  1-10 years

• Number of patients who need repeated focal treatment

  recurrence and recurrent treatment

  1-10 years

• Number of patients eligible for continuous AS+

  1-10 years

• Disease-free survival

  based on repeated MRI and repeat biopsies performed on clinical/ radiological suspicion

  1-10 years

• 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

Secondary Outcomes (2)

• Number of patients where MRI predicted tumor recurrence/ tumor absence

  1-10 years

• Patient Reported Outcomes Measures

  1-10 years

Study Arms (1)

Focal therapy

EXPERIMENTAL

Procedure: high-intensity focused ultrasound, HIFU

Interventions

high-intensity focused ultrasound, HIFU PROCEDURE

see above

Focal therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Male prostate cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital of Vestfold: lead

Study Sites (1)

Vestfold Hospital Trust (Hospital of Vestfold)

Tønsberg, Vestfold, 3103, Norway

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Sven Löffeler

  The Hospital of Vestfold

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sven Löffeler, MD, PhD

CONTACT

+47-33342000; sven.loffeler@siv.no

Sven Löffeler

CONTACT

+4733342000; sven.loffeler@siv.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: September 1, 2020
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)