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Randomiseret kontrolleret forsøg med ProstAtak® immunterapi under aktiv overvågning af prostatakræft (ULYSSES)

30. september 2026 opdateret af: Candel Therapeutics, Inc.

Et randomiseret kontrolleret forsøg med AdV-tk + Valacyclovir administreret under aktiv overvågning for nyligt diagnosticeret prostatakræft

The purpose of this study is to evaluate the effectiveness of CAN-2409 immunotherapy in patients undergoing active surveillance for localized prostate cancer. CAN-2409 involves the use of aglatimagene besadenovec to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. CAN-2409 has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that CAN-2409 can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the CAN-2409 or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

187

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Colorado
      • Golden, Colorado, Forenede Stater, 80401
        • Foothills Urology
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • The University of Chicago
      • Chicago, Illinois, Forenede Stater, 60612
        • Jesse Brown VA Medical Center
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70119
        • Southeast Louisiana Veterans Health Care System
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20889
        • Walter Reed National Military Medical Center
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64128
        • Kansas City VA Medical Center
    • Nevada
      • Reno, Nevada, Forenede Stater, 89502
        • Sierra Nevada Health Care System VA
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center
    • New York
      • North Hills, New York, Forenede Stater, 11042
        • Advanced Radiation Centers of New York (Integrated Medical Professionals)
      • Syracuse, New York, Forenede Stater, 13210
        • Associated Medical Professionals of NY, PLLC
    • Ohio
      • Middleburg Heights, Ohio, Forenede Stater, 44130
        • Southwest Urology, Clinical Research Solutions
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Oklahoma City VA Healthcare System
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • VA Portland Health Care System
      • Springfield, Oregon, Forenede Stater, 97477
        • Oregon Urology Insitute
    • Pennsylvania
      • Lancaster, Pennsylvania, Forenede Stater, 17604
        • Lancaster Urology
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
        • Allegheny Health Network-Triangle Urological Group
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29401
        • Ralph H. Johnson Veterans Affairs Medical Center
    • Texas
      • San Antonio, Texas, Forenede Stater, 78229-4404
        • San Antonio VA Healthcare System
      • The Woodlands, Texas, Forenede Stater, 77384
        • Woodland Center
      • Tomball, Texas, Forenede Stater, 77375
        • Texas Urology Specialists
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23249
        • Hunter Holmes McGuire VA Medical Center
      • Salem, Virginia, Forenede Stater, 24153
        • Salem VA Medical Center
  • Mexico
      • Mexico City, Mexico
        • Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria include:

  • Histologically confirmed adenocarcinoma of the prostate

  • Patients choosing active surveillance

  • Patients meeting definition of NCCN low risk, intermediate risk OR patients having only one NCCN high-risk feature

    • NCCN Low Risk is defined as having all of the following: PSA < 10 ng/ml, Gleason ≤ 6, T1-T2a
    • NCCN Intermediate Risk is defined as having at least one of the following and no high risk features: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c
    • High Risk with a single high risk feature is defined as having only one of the following: PSA>20 ng/ml, Gleason score 8-10, or T3a
    • Excluded are those in the following risk groups: High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1

  • Patients must be planning and medically able to tolerate multiple transrectal ultrasound guided injections.

  • ECOG Performance status 0-2

Exclusion Criteria include:

  • Active liver disease, including known cirrhosis or active hepatitis
  • Patients on systemic corticosteroids (>10 mg prednisone per day) or other immunosuppressive drugs
  • Known HIV+ patients
  • Regional lymph node involvement or distant metastases
  • Other current malignancy (except squamous or basal cell skin cancers)
  • Other serious co-morbid illness or compromised organ function that, in the opinion of the investigator, would interfere with treatment or follow up
  • Prior treatment for prostate cancer except TURP. If prior TURP, patients must be deemed able to receive prostate biopsy and multiple intra-prostatic injections by the investigator
  • Patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride)
  • Patients who had or plan to use ADT or have history of an orchiectomy.
  • Patients who are planning to undergo radical treatment for prostate cancer within 12 months.
  • Known sensitivity or allergic reactions to acyclovir or valacyclovir

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: CAN-2409

Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir
Biologisk: aglatimagene besadenovec

Aglatimagene besadenovec will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second aglatimagene besadenovec injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.

Andre navne:
  • CAN-2409
  • AdV-tk
Medicin: valacyclovir

Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.
Placebo komparator: Placebo

Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir
Medicin: valacyclovir

Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.

Biologisk: placebo

Placebo will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second placebo injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free survival (PFS)
Tidsramme: Baseline to study completion, approximately 5 years

Progression-free survival is defined as the time from randomization to evidence of histological disease progression or death due to prostate cancer
Baseline to study completion, approximately 5 years

Sekundære resultatmål

Resultatmål
Tidsramme
Negativ biopsirate ved 1-års vartegn
Tidsramme: 1 år
1 år
Procentdel af patienter med bivirkninger
Tidsramme: 30 dage efter sidste dosis af undersøgelseslægemidlet
30 dage efter sidste dosis af undersøgelseslægemidlet

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Candel Therapeutics, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2016

Primær færdiggørelse (Faktiske)

1. november 2024

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

6. maj 2016

Først indsendt, der opfyldte QC-kriterier

9. maj 2016

Først opslået (Anslået)

11. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PrTK04

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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