NCT06288113

Brief Summary

This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
21mo left

Started Aug 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Aug 2024Jan 2028

First Submitted

Initial submission to the registry

February 5, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2028

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

February 5, 2024

Last Update Submit

March 11, 2026

Conditions

Castration-Resistant Prostate CarcinomaStage IVB Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

  • 12-month overall survival

    12-month overall survival (OS) of patients with mCRPC who previously had a favorable response to a first regimen of 177Lu-PSMA-617 and are treated with re-challenge 177Lu-PSMA-617 therapy

    Assessed at 12 months

Secondary Outcomes (10)

  • Incidence of adverse events (AEs)

    Assessed approximately at 2 years

  • Rate of prostate specific antigen (PSA) response

    Assessed approximately at 36 weeks

  • Biochemical progression-free survival (PFS)

    Assessed approximately at 2 years

  • Overall Survival from start of first regimen

    Assessed approximately at 2 years

  • Overall survival from the end of the first regimen

    Assessed approximately at 2 years

  • +5 more secondary outcomes

Study Arms (1)

Treatment (177Lu-PSMA-617)

EXPERIMENTAL

Patients receive 177Lu-PSMA-617 IV on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gallium Ga 68 gozetotide IV and undergo PET/CT at screening and on study, undergo SPECT/CT on study, and undergo collection of blood samples throughout the trial.

Procedure: Biospecimen CollectionProcedure: Computed TomographyOther: Gallium Ga 68 GozetotideDrug: Lutetium Lu 177 Vipivotide TetraxetanProcedure: Positron Emission TomographyOther: Questionnaire AdministrationProcedure: Single Photon Emission Computed Tomography

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Treatment (177Lu-PSMA-617)
Computed TomographyPROCEDURE

Undergo PET/CT and SPECT/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography
Treatment (177Lu-PSMA-617)
Gallium Ga 68 GozetotideOTHER

Given IV

Also known as: (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled 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-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-PSMA, 68Ga-PSMA-11, 68Ga-PSMA-HBED-CC, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11, AAA 517, AAA-517, AAA517, Ga PSMA, Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled PSMA-11, GA-68 PSMA-11, Gallium Ga 68 PSMA-11, Gallium Ga 68-labeled 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
Treatment (177Lu-PSMA-617)
Lutetium Lu 177 Vipivotide TetraxetanDRUG

Given IV

Also known as: 177Lu-labeled PSMA-617, 177Lu-PSMA-617, AAA 617, AAA-617, AAA617, Lu177-PSMA-617, Lutetium Lu 177-PSMA-617, LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN, Lutetium-177-PSMA-617, Pluvicto
Treatment (177Lu-PSMA-617)
Positron Emission TomographyPROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Treatment (177Lu-PSMA-617)
Questionnaire AdministrationOTHER

Ancillary studies

Treatment (177Lu-PSMA-617)
Single Photon Emission Computed TomographyPROCEDURE

Undergo SPECT/CT

Also known as: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, ST, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon
Treatment (177Lu-PSMA-617)

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have mCRPC
  • Patients must have received at least one regimen of chemotherapy for mCRPC
  • Patients must have received at least one androgen receptor signaling inhibitor (ARSI)
  • Patients must have previously completed at least 4 cycles of 177Lu-PSMA-617 therapy
  • Patients must have had a favorable response to the first regimen of 177Lu-PSMA-617 therapy defined as:
  • PSA decline of ≥ 50% at any time during the first regimen of 177Lu-PSMA-617 therapy AND
  • No new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation androgen deprivation therapy \[ADT\] is allowed). Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed
  • Patients must have had a PSA increase after the first regimen of 177Lu-PSMA-617 therapy, confirmed by a second measurement ≥ 3 weeks apart
  • Patients must meet PSMA PET/CT VISION criteria. PSMA PET/CT must have been completed within 8 weeks of the planned first cycle of re-challenge 177Lu-PSMA-617 therapy and at least 6 weeks after completion of the first regimen of 177Lu-PSMA-617 therapy
  • White blood cells \> 2,500 cells/µL
  • Absolute neutrophil count \> 1,500 cells/µL
  • Hemoglobin \> 9.0 g/dL
  • Platelets \> 100,000 cells/µL
  • Patients must have the ability to understand and sign an approved informed consent form (ICF) and comply with all protocol requirements

You may not qualify if:

  • Patient received new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation ADT (adenosine triphosphate) is allowed). This can include apalutamide, enzalutamide, abiraterone, chemotherapy, immunotherapy, radionuclide therapy, PARP inhibitor, or any biological therapy. Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed
  • Patient received myelosuppressive therapy (including docetaxel, cabazitaxel, 223Ra, and 153Sm) or other radionuclide therapy within the last 6 weeks
  • Patient with creatinine clearance \< 50 mL/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Specimen Handlinggallium 68 PSMA-1168Ga-DKFZ-PSMA-11PluvictoMagnetic Resonance SpectroscopyX-RaysPhotons

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesSpectrum AnalysisChemistry Techniques, AnalyticalElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, IonizingElementary ParticlesLightOptical PhenomenaRadiation, Nonionizing

Study Officials

  • Jeremie Calais, MD

    UCLA / Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Lira

CONTACT

3102060596StephanieLira@mednet.ucla.edu

Ethan Lam

CONTACT

3102067372clam@mednet.ucla.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2024

First Posted

March 1, 2024

Study Start

August 1, 2024

Primary Completion (Estimated)

January 27, 2027

Study Completion (Estimated)

January 27, 2028

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations

US(1)