Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Escalating Cycle 1 Dose of Lu-177-PSMA-617 for the Treatment of Metastatic Castration Resistant Prostate Cancer (ESCENDO)

26. juni 2026 oppdatert av: University of Michigan Rogel Cancer Center

A Phase 1 Study to Investigate Safety of Escalating Cycle 1 Dose of Lu-177-PSMA-617 Radioligand Therapy (RLT) in Metastatic Castration Resistant Prostate Cancer (mCRPC): The ESCENDO Trial

This phase I trial studies the safety, side effects, and treatment cycle 1 best dose of Lu-177-PSMA-617 in patients with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant) and has spread from where it first started (primary site) to other places in the body (metastatic). Lu-177-PSMA-617 is a radioactive drug. It binds to a protein called prostate-specific membrane antigen (PSMA), which is found on prostate cancer tumor cells. Lu-177-PSMA-617 gives off radiation that may kill these tumor cells. It is a type of radioconjugate. Lu-177-PSMA-617 is currently used in a series of 6 intravenous infusions of the standard dosage, each separated by 6 weeks from the previous infusion. Investigators have observed that the first therapy administration (cycle 1) delivers better radiation treatment to the cancer than each of the following 5 infusions. Giving an increased dosage of Lu-177-PSMA-617 in treatment cycle 1 may have a better effect on metastatic castration-resistant prostate cancer than the standard dosage. The study does not change the total cumulative activity from what is used in the standard dosage treatment but gives an increased dosage in cycle 1 and reduces the total number of cycles.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Forente stater
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan Rogel Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kirk A. Frey, MD
        • Underetterforsker:
          • Yuni Dewaraja, PhD

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Patients must be eligible for standard Lu-177-PSMA617 RLT for mCRPC, including PSMA PET/CT scan positive (lesion uptake > liver uptake by visual assessment)
  • Patients must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e., prior chemotherapy, external beam radiation, brachytherapy, immunotherapy, etc.)
  • Patients must be ≥18 years of age
  • Patients must have an ECOG performance status of 0 or 1
  • Absolute neutrophil count (ANC) ≥ 1500/mm^3
  • Platelet count ≥ 150,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL
  • Estimated glomerular filtration rate (EGFR) ≥ 60ml/min
  • Bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 x ULN is permitted
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤ 5.0 x ULN for patients with liver metastases
  • Albumin > 3.0 g/dL
  • Use effective birth control methods during the treatment and for 14 weeks after the last Lu-177-PSMA-617 dose
  • Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Does not meet criteria for standard Lu-177-PSMA-617 RLT
  • Diffuse marrow involvement evident on Ga-68-PSMA PET/CT as assessed by study treating clinician
  • Prior RLT
  • Unmanageable concurrent bladder outflow obstruction or urinary incontinence
  • Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation
  • Plan to start any additional anti-cancer therapy or investigational agents during study therapy. Anti-cancer therapies include chemotherapy and endocrine therapy
  • Exclusion criteria for participation in other investigational trials: should not participate during RLT or 30 days prior to start of RLT

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: Dose Escalation (Lu-177-PSMA-617)

Patients receive Lu-177-PSMA-617 IV on day 1 of each cycle.

Dose escalation will occur in cycle 1 only: Level 1: 14.8 GBq (7.4 GBq administered 2 times, 2 days apart) Level 2: 22.2 GBq (7.4 GBq administered 3 times, each 2 days apart)

Cycles repeat every 6 weeks for up to 5 cycles for dose level 1 and up to 4 cycles for dose level 2, with the Lu-177-PSMA-617 dose of 7.4 GBq, in the absence of disease progression or unacceptable toxicity. Patients also undergo SPECT/CT scans and receive Ga-68 PSMA-11 and undergo PET/CT after cycle 1.
Annen: Spørreskjemaadministrasjon
Hjelpestudier
Fremgangsmåte: Computertomografi
Gjennomgå SPECT/CT
Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Fremgangsmåte: Bioprøvesamling
Gjennomgå innsamling av urinprøver
Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Legemiddel: Lutetium Lu 177 Vipivotide Tetraxetan
Gitt IV
Andre navn:
  • 177Lu-merket PSMA-617
  • 177Lu-PSMA-617
  • Pluvicto
  • Lu177-PSMA-617
  • Lutetium-177-PSMA-617
  • AAA 617
  • AAA-617
  • AAA617
  • Lutetium Lu 177-PSMA-617
  • LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
Annen: Gallium Ga 68 Gozetotide
Given Ga-68 PSMA-11
Andre navn:
  • (68)Ga-merket Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • (68)Ga-merket Glu-urea-Lys(Ahx)-HBED-CC
  • (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • (68Ga)Glu-urea-Lys(Ahx)-HBED-CC
  • 68Ga-DKFZ-PSMA-11
  • 68Ga-HBED-CC-PSMA
  • 68Ga-merket Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • 68Ga-PSMA
  • 68Ga-PSMA-11
  • 68Ga-PSMA-HBED-CC
  • [68Ga] Prostata-spesifikt membranantigen 11
  • [68Ga]GaPSMA-11
  • Ga PSMA
  • Ga-68 merket DKFZ-PSMA-11
  • Ga-68 merket PSMA-11
  • GA-68 PSMA-11
  • Gallium Ga 68 PSMA-11
  • Gallium Ga 68-merket PSMA-11
  • GALLIUM GA-68 GOZETOTIDE
  • Gallium-68 PSMA
  • Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • GaPSMA
  • PSMA-HBED-CC GA-68
  • AAA 517
  • AAA-517
  • AAA517
Enhet: Positron Emission Tomography
Undergo PET
Andre navn:
  • Medisinsk bildebehandling, positronemisjonstomografi
  • KJÆLEDYR
  • PET-skanning
  • Positron Emission Tomography Scan
  • Positron-utslippstomografi
  • PT
  • Positronemisjonstomografi (prosedyre)
Enhet: Single Photon Emission Computed Tomography
Undergo SPECT/CT
Andre navn:
  • ST
  • Medisinsk bildebehandling, enkeltfoton-emisjons-tomografi
  • Enkeltfotonutslippstomografi
  • enkeltfoton emisjon datatomografi
  • SPECT
  • SPECT-avbildning
  • SPECT SCAN
  • SPET
  • tomografi, emisjonsberegnet, enkelt foton
  • Tomografi, Emission-Computed, Single-Photon
  • Enkeltfotoutslipp beregnet
Annen: Technetium Tc-99m Sulfur Colloid
Given IV
Andre navn:
  • Tc 99m Svovelkolloid
  • Tc-99m SC
  • Technetium Tc 99m Svovelkolloid

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Dose limiting toxicity (DLT)
Tidsramme: up to 6 weeks
The rate of drug-related adverse events that meet protocol-specified dose-limiting criteria and occur during the time period from administration of cycle 1 dosage up to administration of cycle 2 dosage.
up to 6 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of treatment related adverse events
Tidsramme: at 6 weeks after first dose and 12 weeks after last dose
Any treatment related adverse events of Grade 3 or higher (according to CTCAE v5.0) from time of cycle 1 administration until time of cycle 2 administration and from time of cycle 1 administration until 12 weeks after the last cycle administration
at 6 weeks after first dose and 12 weeks after last dose
Completion of overall multi-cycle (4-5 cycles) planned treatment course
Tidsramme: Up to 30 weeks
To determine the rate of successful completion of the complete planned treatment course (total of 4 or 5 cycles)
Up to 30 weeks
Biochemical (prostate-specific antigen [PSA]) response
Tidsramme: at 6 weeks after first dose and 12 weeks after last dose
Will be estimated as the proportion of patients with ≥ 50% drop in serum PSA levels from baseline to 6 weeks after first cycle and from baseline to 12 weeks after last cycle
at 6 weeks after first dose and 12 weeks after last dose
PSMA PET/CT response
Tidsramme: at 6 weeks after first dose and 12 weeks after last dose
Will be estimated as the proportion of patients with ≥ 30% drop in PSMA positive tumor volume on PET/CT from baseline to 6 weeks after first cycle and from baseline to 12 weeks after last cycle
at 6 weeks after first dose and 12 weeks after last dose

Samarbeidspartnere og etterforskere

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

Sponsor

University of Michigan Rogel Cancer Center

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Kirk A Frey, MD, University of Michigan Rogel Cancer Center

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 (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. august 2031

Datoer for studieregistrering

Først innsendt

26. juni 2026

Først innsendt som oppfylte QC-kriteriene

26. juni 2026

Først lagt ut (Faktiske)

6. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • UMCC 2023.044
  • R01CA289631 (U.S. NIH-stipend/kontrakt)
  • NCI-2025-01952 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • HUM00234038 (Annen identifikator: University of Michigan Rogel Cancer Center)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere