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177Lu radioaktivt mærket monoklonalt antistof HuJ591 (177Lu-J591) og ketoconazol hos patienter med prostatakræft

21. oktober 2026 opdateret af: Weill Medical College of Cornell University

Et randomiseret fase 2-forsøg med 177Lu radioaktivt mærket monoklonalt antistof HuJ591 (177Lu-J591) og ketoconazol hos patienter med højrisikokastrat biokemisk recidiverende prostatakræft efter lokal terapi

The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 in combination with ketoconazole and hydrocortisone against prostate cancer.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This research is being done because the standard treatments for prostate cancer that has returned (PSA is elevated) after surgery and/or radiation and progressed on initial hormonal therapy are not curative. Existing treatments, such as the ketoconazole used as part of this study may decrease PSA temporarily, but unfortunately the cancer continues to grow. This experimental drug is designed to seek out all of the prostate cancer cells and to deliver a lethal dose of radiation to the areas of cancer, but not to normal areas. Some of the normal organs (liver, kidney and bone marrow) do receive some radiation dose that is within the acceptable limits.

The experimental drug in this study includes an antibody (abbreviated: mAb) called "J591". It is a protein molecule which can bind to a specific site on a prostate cancer cell. A very energetic radioactive (an unstable atom) metal called 177Lutetium (abbreviated: 177Lu) is attached to the J591 antibody. The fully assembled drug is called "177Lu-J591". The study will assess the potential of the energy given off by the radioactive compound to kill cancer cell. This study may also involve the use of 111Indium (abbreviated 111In). This is also an energetic radioactive particle, but does not generally give off enough energy to kill cancer cells, but allows researchers to take pictures. This radioactive particle is also attached to the J591 antibody (called 111In-J591) and will serve as a placebo (treatment with no active medicine).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

55

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
    • California
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars Sinai
      • Los Angeles, California, Forenede Stater, 90089
        • USC/Norris Comprehensive cancer center
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20007
        • Georgetown University Medical Center
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University Melvin and Bren Simon Cancer Center
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Westwood, Kansas, Forenede Stater, 66205
        • The University of Kansas Cancer Center
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68130
        • XCancer Omaha
    • New York
      • New York, New York, Forenede Stater, 10021
        • Weill Cornell Medical College
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • UPMC Hillman Cancer Center
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84108
        • University of Utah

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:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or radiotherapy.

  • Biochemical progression (rising PSA) after medical or surgical castration

  • High risk of systemic progression defined as:

    1. Rising PSA as defined above and either:
    2. Absolute PSA > 20 ng/mL AND/OR
    3. PSA doubling time < 8 months

  • No evidence of local recurrence or distant metastases

  • Age >18 years.

  • Serum testosterone < 50 ng/ml

  • Patients capable of fathering children must agree to use an effective method of contraception for the duration of the trial.

  • Subjects on bisphosphonate therapy must be on a stable dose and must have started therapy > 4 weeks prior to protocol therapy.

  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Use of red blood cell or platelet transfusions within 4 weeks of treatment

  • Use of hematopoietic growth factors within 4 weeks of treatment

  • Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment

  • Prior radiation therapy encompassing >25% of skeleton (see Appendix C)

  • Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®)

  • Platelet count <150,000/mm3 or known primary qualitative platelet disorder

  • Absolute neutrophil count (ANC) <2,000/mm3

  • Hematocrit <30 percent and Hemoglobin < 10 g/dL

  • Abnormal coagulation profile (PT or INR, PTT > 1.3x ULN) unless on therapeutic anticoagulation - see concomitant meds section

  • Serum creatinine >2.5 mg/dL

  • AST (SGOT) >2x ULN

  • Bilirubin (total) >1.5x ULN; subjects with Gilbert's syndrome will be allowed if direct bilirubin is within institutional normal limits

  • Active serious infection

  • Active angina pectoris or NY Heart Association Class III-IV

  • ECOG Performance Status > 2

  • Life expectancy <12 months

  • History of deep vein thrombosis and/or pulmonary embolus within 1 month of study entry

  • Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study

  • Prior investigational therapy (medications or devices) within 4 weeks of treatment. Furthermore, other investigational therapy is not permitted during the treatment phase.

  • Prior use of ketoconazole for the purposes of prostate cancer therapy for greater than 1 month

  • Known history of HIV. The effects of J591 are unknown in this population. Furthermore, ketoconazole has many well-described drug-drug interactions which could affect antiviral therapy. If necessary, this population will be studied separately.

  • Currently active other malignancy other than non-melanoma skin cancer. Patients are considered not to have "currently active" malignancy if they have completed any necessary therapy and are considered by their physician to be at less than 30% risk of relapse.

    - Known history of known myelodysplastic syndrome

  • Adrenal hormone inhibitors (other than ketoconazole) within 4 weeks prior to study enrollment

  • Finasteride (Propecia® or Proscar®) or dutasteride (Avodart®) within 4 weeks of enrollment

  • Patients on corticosteroids prior to enrollment must have either discontinued and shown biochemical progression or have biochemical progression on a stable dose

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
Eksperimentel: 1. 177Lu-J591 + Ketoconazole

Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 177Lu-J591 Infusion, continue ketoconazole and hydrocortisone
Medicin: 177Lu-J591

177Lu-J591 70 mCi/m2 on day 29 (+/- 2 days) of treatment

Andre navne:
  • J591
Medicin: Ketoconazole

Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)

Andre navne:
  • Nizoral
Medicin: Hydrocortisone

Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)

Andre navne:
  • Cortef
Placebo komparator: 2. 111In-J591 + Ketoconazole

Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 111In-J591 (placebo) Infusion, continue ketoconazole and hydrocortisone
Medicin: Ketoconazole

Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)

Andre navne:
  • Nizoral
Medicin: Hydrocortisone

Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)

Andre navne:
  • Cortef
Medicin: 111In-J591

111In-J591 at a dose of 5 mCi on day 29 (+/- 2 days) of treatment

Andre navne:
  • J591

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants Free of Radiographically Evident Metastases From Baseline to 18 Months After Study Drug Administration
Tidsramme: Baseline and 18 months after study drug administration

Subjects will perform a CT and/or MRI scan of the abdomen and pelvis, chest x-ray or CT scan of the chest and bone scan to determine the proportion of participants free of radiographically evident metastases from baseline to 18 months after study drug administration.
Baseline and 18 months after study drug administration

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in PSA Response Rate
Tidsramme: Collected at screening, V2, V3, V5, V9 then every 4 weeks till PSA progression or end of study at approximately 100 months

PSA response will be determined by comparing the PSA levels after therapy to the baseline and pre-treatment PSA via blood specimens
Collected at screening, V2, V3, V5, V9 then every 4 weeks till PSA progression or end of study at approximately 100 months

Samarbejdspartnere og efterforskere

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

Sponsor

Weill Medical College of Cornell University

Samarbejdspartnere

United States Department of Defense

Efterforskere

  • Ledende efterforsker: Scott T Tagawa, M.D., Weill Medical College of Cornell University

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 (Faktiske)

1. juni 2009

Primær færdiggørelse (Faktiske)

10. februar 2022

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

10. marts 2009

Først indsendt, der opfyldte QC-kriterier

10. marts 2009

Først opslået (Anslået)

11. marts 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0810010067
  • J591+Ketoconazole (Anden identifikator: Weill Cornell Medicine)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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