Randomisert kontrollert utprøving av ProstAtak® immunterapi under aktiv overvåking for prostatakreft (ULYSSES)
En randomisert kontrollert prøveversjon av AdV-tk + Valacyclovir administrert under aktiv overvåking for nylig diagnostisert prostatakreft
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Colorado
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Golden, Colorado, Forente stater, 80401
- Foothills Urology
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Illinois
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Chicago, Illinois, Forente stater, 60637
- The University of Chicago
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Chicago, Illinois, Forente stater, 60612
- Jesse Brown VA Medical Center
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Louisiana
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New Orleans, Louisiana, Forente stater, 70119
- Southeast Louisiana Veterans Health Care System
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Maryland
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Bethesda, Maryland, Forente stater, 20889
- Walter Reed National Military Medical Center
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Missouri
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Kansas City, Missouri, Forente stater, 64128
- Kansas City VA Medical Center
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Nevada
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Reno, Nevada, Forente stater, 89502
- Sierra Nevada Health Care System VA
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New Jersey
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Hackensack, New Jersey, Forente stater, 07601
- Hackensack University Medical Center
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New York
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North Hills, New York, Forente stater, 11042
- Advanced Radiation Centers of New York (Integrated Medical Professionals)
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Syracuse, New York, Forente stater, 13210
- Associated Medical Professionals of NY, PLLC
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Ohio
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Middleburg Heights, Ohio, Forente stater, 44130
- Southwest Urology, Clinical Research Solutions
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- Oklahoma City VA Healthcare System
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Oregon
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Portland, Oregon, Forente stater, 97239
- VA Portland Health Care System
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Springfield, Oregon, Forente stater, 97477
- Oregon Urology Insitute
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Pennsylvania
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Lancaster, Pennsylvania, Forente stater, 17604
- Lancaster Urology
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Pittsburgh, Pennsylvania, Forente stater, 15212
- Allegheny Health Network-Triangle Urological Group
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South Carolina
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Charleston, South Carolina, Forente stater, 29401
- Ralph H. Johnson Veterans Affairs Medical Center
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Texas
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San Antonio, Texas, Forente stater, 78229-4404
- San Antonio VA Healthcare System
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The Woodlands, Texas, Forente stater, 77384
- Woodland Center
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Tomball, Texas, Forente stater, 77375
- Texas Urology Specialists
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Virginia
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Richmond, Virginia, Forente stater, 23249
- Hunter Holmes McGuire VA Medical Center
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Salem, Virginia, Forente stater, 24153
- Salem VA Medical Center
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Mexico City, Mexico
- Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria include:
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Histologically confirmed adenocarcinoma of the prostate
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Patients choosing active surveillance
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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
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Patients must be planning and medically able to tolerate multiple transrectal ultrasound guided injections.
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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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: CAN-2409
Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir |
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 navn:
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 |
Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection. 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 landemerke
Tidsramme: 1 år
|
1 år
|
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Andel pasienter med uønskede hendelser
Tidsramme: 30 dager etter siste dose av studiemedikamentet
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30 dager etter siste dose av studiemedikamentet
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Antatt)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Genitale neoplasmer, hanner
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Kjønnssykdommer, mannlige
- Prostata sykdommer
- Mannlige urogenitale sykdommer
- Prostatiske neoplasmer
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Guanin
- Hypoksantiner
- Purinoner
- Puriner
- Acyclovir
- Valacyclovir
Andre studie-ID-numre
- PrTK04
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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