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

26. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Fase 1

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Rogel Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Kirk A. Frey, MD
        • Underforsker:
          • Yuni Dewaraja, PhD

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Spørgeskemaadministration
Hjælpestudier
Procedure: Computertomografi
Gennemgå SPECT/CT
Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type
Procedure: Bioprøvesamling
Gennemgå indsamling af urinprøver
Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Medicin: Lutetium Lu 177 Vipivotide Tetraxetan
Givet IV
Andre navne:
  • 177Lu-mærket 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
Andet: Gallium Ga 68 Gozetotide
Given Ga-68 PSMA-11
Andre navne:
  • (68)Ga-mærket Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • (68)Ga-mærket 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-mærket Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • 68Ga-PSMA
  • 68Ga-PSMA-11
  • 68Ga-PSMA-HBED-CC
  • [68Ga] Prostata-specifikt membranantigen 11
  • [68Ga]GaPSMA-11
  • Ga PSMA
  • Ga-68 mærket DKFZ-PSMA-11
  • Ga-68 mærket PSMA-11
  • GA-68 PSMA-11
  • Gallium Ga 68 PSMA-11
  • Gallium Ga 68-mærket 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
Enhed: Positron Emission Tomography
Undergo PET
Andre navne:
  • Medicinsk billeddannelse, Positron Emission Tomografi
  • KÆLEDYR
  • PET-scanning
  • Positron Emission Tomografi Scan
  • Positron-emissionstomografi
  • PT
  • Positron emissionstomografi (procedure)
Enhed: Single Photon Emission Computed Tomography
Undergo SPECT/CT
Andre navne:
  • ST
  • Medicinsk billeddannelse, enkelt fotonemission computertomografi
  • Single Photon Emission Tomografi
  • enkelt-foton emission computertomografi
  • SPECT
  • SPECT billeddannelse
  • SPECT SCANNING
  • SPET
  • tomografi, emissionsberegnet, enkelt foton
  • Tomografi, Emission-beregnet, Single-Photon
  • Enkeltfoto-emission beregnet
Andet: Technetium Tc-99m Sulfur Colloid
Given IV
Andre navne:
  • Tc 99m Svovlkolloid
  • Tc-99m SC
  • Technetium Tc 99m Svovlkolloid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

University of Michigan Rogel Cancer Center

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

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

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 (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. august 2031

Datoer for studieregistrering

Først indsendt

26. juni 2026

Først indsendt, der opfyldte QC-kriterier

26. juni 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

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

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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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