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ClinicalTrials.gov public records Last synced Oct 23, 2026, 9:48 AM EDT

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Showing 1–24 of 30 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Lu-PSMA-617 Clear all
Recruiting Phase 3 Interventional

Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC

NCT06855277
View directory record Official record
Conditions
Prostate Cancer
Interventions
AAA817, ARPI, Standard of Care
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years · Male only
Enrollment
940 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2032
U.S. locations
42
States / cities
Homewood, Alabama • Tucson, Arizona • Orange, California + 37 more
Source: ClinicalTrials.gov public record
Updated Oct 15, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Recruiting Phase 1Phase 2 Interventional

STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer

NCT06574880
View directory record Official record
Conditions
Malignant Neoplasm of Prostate, Locally Advanced Prostate Cancer
Interventions
Lu-PSMA-617, 5-fraction Stereotactic Body Radiation Therapy (SBRT)
Drug · Radiation
Lead sponsor
Angela Y. Jia, MD PhD
Other
Eligibility
18 Years and older · Male only
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated May 26, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Not yet recruiting Phase 2 Interventional

Pluvicto for the Treatment of African American Men With Metastatic Castration-Resistant Prostate Cancer

NCT07860554
View directory record Official record
Conditions
Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
Interventions
Biopsy Procedure, Biospecimen Collection, Bone Scan, Computed Tomography, Lutetium Lu 177 Vipivotide Tetraxetan, PSMA PET Scan, Questionnaire Administration, Single Photon Emission Computed Tomography
Procedure · Drug · Other
Lead sponsor
Emory University
Other
Eligibility
18 Years and older · Male only
Enrollment
88 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Oct 6, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Recruiting Phase 1Phase 2 Interventional

A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC

NCT07226986
View directory record Official record
Conditions
PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy
Interventions
AMO959, AAA617, Enzalutamide, Abiraterone
Drug · Radiation
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older · Male only
Enrollment
123 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
4
States / cities
Los Angeles, California • Durham, North Carolina • El Paso, Texas + 1 more
Source: ClinicalTrials.gov public record
Updated Oct 15, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Recruiting Phase 1 Interventional

A Study of 177Lu-PSMA-617 in People With Gliomas

NCT07223034
View directory record Official record
Conditions
Glioma, Diffuse Astrocytoma, IDH-Wildtype (Grade 2-4), Glioblastoma, IDH-wildtype, Diffuse Midline Glioma, H3 K27-Altered, Diffuse Hemispheric Glioma, H3 G34-mutant, Diffuse Pediatric-type High-grade Glioma, H3-wildtype and IDH-wildtype
Interventions
Temozolomide, 177Lu-PSMA-617, 68Ga-PSMA-PET scan/ MRI, Quality of Life Questionnaires
Drug · Diagnostic Test · Behavioral
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
7
States / cities
Basking Ridge, New Jersey • Middletown, New Jersey • Montvale, New Jersey + 4 more
Source: ClinicalTrials.gov public record
Updated Jun 4, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Recruiting Phase 2Phase 3 Interventional

Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

NCT06780670
View directory record Official record
Conditions
Prostate Cancer
Interventions
Investigators choice of SoC, AAA817
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years · Male only
Enrollment
443 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2033
U.S. locations
35
States / cities
Scottsdale, Arizona • Los Angeles, California • Palo Alto, California + 30 more
Source: ClinicalTrials.gov public record
Updated Sep 22, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Recruiting Phase 2 Interventional

68Ga-PSMA-11 PET-directed Radioligand Therapy in Metastatic Hepatocellular Carcinoma (HCC)

NCT06852820
View directory record Official record
Conditions
Liver Cancer, Hepatocellular Carcinoma, Metastatic Liver Cancer
Interventions
Lu-PSMA-617
Drug
Lead sponsor
Melissa Lumish
Other
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated May 8, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Recruiting Phase 2 Interventional

Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)

NCT06216249
View directory record Official record
Conditions
Prostate Carcinoma, Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8
Interventions
Computed Tomography, Gallium Ga 68 Gozetotide, Lutetium Lu 177 Vipivotide Tetraxetan, Positron Emission Tomography, PSMA PET Scan, Questionnaire Administration, Single Photon Emission Computed Tomography
Procedure · Other · Drug
Lead sponsor
Jonsson Comprehensive Cancer Center
Other
Eligibility
18 Years and older · Male only
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Mar 10, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Active, not recruiting Phase 2 Interventional

177LuPSMA in Renal Cell Carcinoma

NCT06964958
View directory record Official record
Conditions
Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma, Kidney Cancer
Interventions
177Lu-PSMA-617
Drug
Lead sponsor
Dana-Farber Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
2
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Feb 24, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Recruiting Phase 1Phase 2 Interventional

Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer

NCT05113537
View directory record Official record
Conditions
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Metastatic Castration-resistant Prostate Carcinoma, Metastatic Castration-resistant Prostate Cancer
Interventions
Abemaciclib, Lutetium Lu 177-PSMA-617
Drug
Lead sponsor
Vadim S Koshkin
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2028
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Jul 24, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Recruiting Phase 2 Interventional

Measuring Circulating Tumor Deoxyribonucleic Acid Tumor Fraction to Guide Early 177Lu-PSMA-617 Treatment Discontinuation in Patients With Metastatic Castration-Resistant Prostate Cancer, DYNAMO Trial

NCT07698535
View directory record Official record
Conditions
Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
Interventions
Lutetium Lu 177 Vipivotide Tetraxetan, Cell-free Circulating Tumor DNA Assay, Computed Tomography, Docetaxel, PSMA PET Scan, Single Photon Tomography and Computed Tomography Scan, Biospecimen Collection
Drug · Procedure
Lead sponsor
University of Washington
Other
Eligibility
18 Years and older · Male only
Enrollment
64 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Oct 19, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Recruiting Phase 1 Interventional

177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer

NCT07219147
View directory record Official record
Conditions
Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
Interventions
Biospecimen Collection, Bone Scan, Computed Tomography, Leukapheresis, Lutetium Lu 177 Vipivotide Tetraxetan, Magnetic Resonance Imaging, PSMA PET Scan, Sipuleucel-T
Procedure · Drug · Biological
Lead sponsor
City of Hope Medical Center
Other
Eligibility
18 Years and older · Male only
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
Duarte, California
Source: ClinicalTrials.gov public record
Updated Apr 20, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Active, not recruiting Phase 2 Interventional

A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

NCT07047118
View directory record Official record
Conditions
Prostatic Cancer, Castration-Resistant
Interventions
JSB462, AAA617
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older · Male only
Enrollment
138 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
10
States / cities
Duarte, California • Santa Monica, California • Denver, Colorado + 7 more
Source: ClinicalTrials.gov public record
Updated Oct 9, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Recruiting Phase 2 Interventional

Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma

NCT07150715
View directory record Official record
Conditions
Oligometastatic Prostate Adenocarcinoma, Recurrent Prostate Adenocarcinoma
Interventions
Actinium Ac 225 Vipivotide Tetraxetan, Biospecimen Collection, Gallium Ga 68 Gozetotide, Lutetium Lu 177 Vipivotide Tetraxetan, PSMA PET-CT Scan, Stereotactic Body Radiation Therapy
Drug · Procedure · Other + 1 more
Lead sponsor
Jonsson Comprehensive Cancer Center
Other
Eligibility
18 Years and older · Male only
Enrollment
107 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2031
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Sep 17, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Recruiting Phase 2 Interventional

Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease

NCT06526299
View directory record Official record
Conditions
Metastatic Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Interventions
Biospecimen Collection, Bone Scan, Computed Tomography, Lutetium Lu 177 Vipivotide Tetraxetan, Magnetic Resonance Imaging, PSMA PET-CT Scan, Questionnaire Administration, Single Photon Emission Computed Tomography
Procedure · Drug · Other
Lead sponsor
University of Washington
Other
Eligibility
18 Years and older · Male only
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
3
States / cities
San Francisco, California • Sylmar, California • Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Jul 7, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Suspended Phase 2 Interventional

Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer

NCT06200103
View directory record Official record
Conditions
Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Interventions
Biospecimen Collection, Bone Scan, Clinical Observation, Computed Tomography, Gallium Ga 68 Gozetotide, Lutetium Lu 177 Vipivotide Tetraxetan, Positron Emission Tomography, Questionnaire Administration, Single Photon Emission Computed Tomography
Procedure · Other · Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older · Male only
Enrollment
236 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Aug 20, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Active, not recruiting Phase 2 Interventional

Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function

NCT06004661
View directory record Official record
Conditions
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Interventions
AAA617, 68Ga-PSMA-11
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years · Male only
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jul 10, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Recruiting Phase 4 Interventional

Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer

NCT05803941
View directory record Official record
Conditions
Prostate Cancer
Interventions
AAA617
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years · Male only
Enrollment
700 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2033
U.S. locations
24
States / cities
Scottsdale, Arizona • Orange, California • Santa Monica, California + 19 more
Source: ClinicalTrials.gov public record
Updated Jun 4, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Active, not recruiting Phase 1 Interventional

NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.

NCT06379217
View directory record Official record
Conditions
Metastatic Neuroendocrine Prostate Cancer
Interventions
[68Ga]Ga-PSMA-11, [68Ga]GA-DOTA-TATE, [68Ga]Ga-NeoB, [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE, [177Lu]Lu-NeoB, L-Lysine HCl-L-Arginine HCl, 2.5 %,, Gonadotropin-releasing hormone (GnRH) analogues, GnRH antagonists, Antiemetics & antinauseants, Metoclopramide
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years · Male only
Enrollment
31 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
2
States / cities
Omaha, Nebraska • New York, New York
Source: ClinicalTrials.gov public record
Updated Oct 15, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Recruiting Phase 2 Interventional

Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial

NCT07650240
View directory record Official record
Conditions
Recurrent Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8, Castration-Sensitive Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Prostate Cancer, Prostate Adenocarcinoma, Adenocarcinoma of the Prostate, Localized Prostate Carcinoma, Metastatic Prostate Cancer, Metastatic Prostate Adenocarcinoma, Advanced Prostate Cancer, Advanced Prostate Adenocarcinoma
Interventions
Abiraterone Acetate, Biospecimen Collection, Leuprolide Acetate, Lutetium Lu 177 Vipivotide Tetraxetan, Prednisone, PSMA PET-CT Scan, Quality-of-Life Assessment, Single Photon Emission Computed Tomography
Drug · Procedure · Other
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older · Male only
Enrollment
202 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Sep 18, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Active, not recruiting Phase 1 Interventional

A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study

NCT06531499
View directory record Official record
Conditions
Metastatic Castration-Resistant Prostate Cancer
Interventions
AAA617, Gonadotropin-releasing hormone (GnRH) analogues, Gonadotropin-releasing hormone (GnRH) antagonists
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years · Male only
Enrollment
110 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
5
States / cities
Los Angeles, California • Palo Alto, California • Rochester, Minnesota + 2 more
Source: ClinicalTrials.gov public record
Updated Oct 20, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Active, not recruiting Phase 1 Interventional

LuCarbo - a Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer

NCT06303713
View directory record Official record
Conditions
Prostate Cancer, Metastatic Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
Interventions
Carboplatin, 177Lu-PSMA-617
Drug
Lead sponsor
Dana-Farber Cancer Institute
Other
Eligibility
18 Years and older · Male only
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
3
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Apr 8, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Recruiting Phase 1 Interventional

Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617

NCT07054346
View directory record Official record
Conditions
Prostate Cancer, Prostate Cancer (Diagnosis), High-risk Prostate Cancer, Localized Prostate Carcinoma, Very High Risk Prostate Carcinoma
Interventions
177 Lutetium Prostate-Specific Membrane Antigen 617, Actinium-225 Prostate-Specific Membrane Antigen 617, Non-investigational, Prostatectomy, Prostate Tissue Collection, Single-photon emission computed tomography (SPECT)/Computerized tomography (CT), Blood Sample Collection
Drug · Procedure
Lead sponsor
Thomas Hope
Other
Eligibility
18 Years and older · Male only
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Aug 28, 2026 · Synced Oct 23, 2026, 9:48 AM EDT
Recruiting Phase 2 Interventional

Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer

NCT06738303
View directory record Official record
Conditions
Metastatic Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
Interventions
Cabazitaxel and carboplatin, Lu-PSMA-617
Drug
Lead sponsor
Case Comprehensive Cancer Center
Other
Eligibility
19 Years and older
Enrollment
44 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Oct 2, 2026 · Synced Oct 23, 2026, 9:48 AM EDT