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Mikroultralydstyrt fokal laserablasjon for intermediærrisikoprostatakreft: Sikkerhet og effektivitet (MicroUSgFLA)

24. september 2026 oppdatert av: University Health Network, Toronto

Mikroultralydveiledet fokal laserablasjon (MicroUSgFLA) behandling for håndtering av intermediær risiko prostatakreft: Evaluering av sikkerhet og effektivitet

This clinical research study is intended to show that Micro-Ultrasound Guided Focal Laser Ablation (MicroUSgFLA) is a safe procedure that can significantly postpone or eliminate the need for patients with intermediate-Risk prostate cancer (PCa) to undergo a definitive treatment (i.e., Radical Prostatectomy or Radiation Therapy) for their disease.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Prostate cancer is the most common cancer in men, and a large proportion of these diagnoses are of the low or intermediate risk type that are amenable to a minimally invasive approach to treatment such as Focal Therapy. If successful, this study will show that trans-perineal interstitial laser focal therapy of the prostate could be offered over a wider community setting than only at a major hospital as an Magnetic Resonance Imaging (MRI), to confidently locate the Index Lesion would not be required because MicroUS is showing the same potential to visualize the lesion. MicroUS-guided focal laser ablation would be a simpler treatment than the complexity required under MRI, it could be offered in communities that might not have local access to MRI facilities and could be offered to individuals who are contra-indicated for MRI for such reasons as having metallic implants or severe claustrophobia.

Studietype

Intervensjonell

Registrering (Antatt)

7

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Rekruttering
        • University Health Network - Princess Margaret Cancer Centre
        • Underetterforsker:
          • Nathan Perlis, MD
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sangeet Ghai, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • Men 40-80 years of age.
  • Histologically-proven intermediate-risk PCa (Gleason score 7, primary grade ≤ 4).
  • PCa clinical stage T1c or T2.
  • MRI/MicroUS site suspicious for cancer or cancer mapped to one prostate lobe.
  • Maximum dimension of MRI/MicroUS visible tumour ≤15mm.
  • Suspicious site on Prostate MRI/MicroUS must coincide with sector positive for cancer on biopsy.
  • Prostate specific antigen (PSA) level < 15 ng/mL.
  • IPSS, ICIQ-UI-SF, IIEF-15 questionnaires completed prior to the procedure.
  • Life expectancy of greater than 10 years, based on co-morbidity not related to PCa.

Exclusion Criteria:

  • Maximum dimension of MRI/MicroUS visible tumour > 15 mm.
  • Patients medically unfit for focal therapy of the prostate.
  • Patients who are unwilling or unable to give informed consent.
  • Patients who have received androgen suppression therapy.
  • Patients who have received or are receiving chemotherapy for prostate carcinoma.
  • Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive) including HIFU, TUNA, RITA, microwave, cryotherapy or any curative treatment.
  • Patients who have undergone radiation therapy for PCa or to the pelvis.
  • Any condition or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies).
  • Patients with a history of non-compliance with medical therapy and/or medical recommendations.
  • Patients who are unwilling or unable to complete the patient self-assessment questionnaires.
  • Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition.
  • Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days.
  • Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Single-Arm Prospective Clinical Trial

This is a single arm study where patients with intermediate risk MR visible locally confined prostate cancer will be treated with Micro-Ultrasound Guided Focal Laser Ablation. Following treatment, the patients will be assessed by MRI and Biopsy at 6 months with PSA.
Fremgangsmåte: 6 month, prospective, interventional single-arm safety and effectiveness study

x

Andre navn:
  • MicroUSgFLA-behandling
  • Fokal laserablasjon behandling
  • Minimalt invasive behandlinger for prostatakreft
Enhet: The TRANBERG|CLS Thermal therapy

Micro Ultrasound Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS|Thermal Therapy

Andre navn:
  • ExactVu Mikroultralydsystem

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Primary Outcome 1:
Tidsramme: From enrollment to the end of treatment at 6 months.

Number of Participants With Procedure-Related Adverse Events Time Frame: Up to 6 months after procedure Outcome Type: Safety

Measure Description:

Number and severity of procedure-related adverse events (AEs), graded according to CTCAE v5.0, to evaluate the safety profile of focal Micro-Ultrasound-Guided Focal Laser Ablation (MicroUS-gFLA) in patients with organ-confined intermediate-risk prostate cancer.

Unit of Measure: Number of participants
From enrollment to the end of treatment at 6 months.
Primary Outcome 2: Technical Success Rate of MicroUS-gFLA
Tidsramme: From enrollment to the end of treatment at 6 months

Primary Outcome 2: Technical Success Rate of MicroUS-gFLA

Time Frame: At completion of procedure; confirmed during follow-up up to 6 months Outcome Type: Feasibility

Measure Description:

Proportion of procedures achieving technical success, defined as: successful visualization and MicroUS-guided trocar insertion into the target lesion, and completion of focal laser ablation exactly as planned, as confirmed by intra-procedural imaging and follow-up mpMRI and/or biopsy. Unit of Measure: Percentage of procedures
From enrollment to the end of treatment at 6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Secondary Outcome 1 - Change in PSA Level From Baseline
Tidsramme: From enrollment to the end of treatment at 6 months.

Secondary Outcome 1 - Change in PSA Level From Baseline

Time Frame: Baseline to 6 months Outcome Type: Efficacy

Measure Description:

Change in serum prostate-specific antigen (PSA) level from baseline prior to ablation to 6-month follow-up.

Unit of Measure: Change in PSA (ng/mL)
From enrollment to the end of treatment at 6 months.
Secondary Outcome 2: Change in Urinary Function (IPSS Score)
Tidsramme: From enrollment to the end of the treatment at 6 months

Secondary Outcome 2: Change in Urinary Function (IPSS Score)

Time Frame: Baseline, 3 months, and 6 months Outcome Type: Functional

Measure Description:

Change in urinary function measured using the International Prostate Symptom Score (IPSS).

Unit of Measure: Change in score (IPSS scale)
From enrollment to the end of the treatment at 6 months
Secondary Outcome 3: Change in Erectile Function (IIEF-15 Score)
Tidsramme: From enrollment to the end of treatment at 6 months

Secondary Outcome 3: Change in Erectile Function (IIEF-15 Score)

Time Frame: Baseline, 3 months, and 6 months Outcome Type: Functional

Measure Description:

Change in erectile function measured using the International Index of Erectile Function-15 (IIEF-15) questionnaire.

Unit of Measure: Change in score (IIEF-15 scale)
From enrollment to the end of treatment at 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Health Network, Toronto

Samarbeidspartnere

Clinical Laserthermia Systems AB
Exact Imaging

Etterforskere

  • Hovedetterforsker: Sangeet Ghai, MD, The Princess Margaret Cancer Foundation

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. april 2025

Primær fullføring (Antatt)

31. mai 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

4. september 2025

Først innsendt som oppfylte QC-kriteriene

5. januar 2026

Først lagt ut (Faktiske)

14. januar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 21-6189

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data that relate to the results reported in the primary publication (e.g., baseline demographics, imaging findings, treatment parameters, outcomes, and adverse events).

IPD-delingstidsramme

Beginning 6 months after publication of the primary results for up to 5 years thereafter.

Tilgangskriterier for IPD-deling

Data will be available to investigators with methodologically sound research proposals for use in projects related to prostate imaging, focal therapy, or outcomes research. All requestors will be required to sign a data use agreement to ensure participant confidentiality.

Data requests should be submitted to the study principal investigator. Approved proposals will be granted access via a secure institutional data-sharing platform.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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