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Showing 1–21 of 21 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: AAA617 Clear all
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 3, 2026 · Synced Sep 1, 2026, 2:40 PM 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 6, 2026 · Synced Sep 1, 2026, 2:40 PM EDT
Not yet 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 Jun 16, 2026 · Synced Sep 1, 2026, 2:40 PM 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 Dec 16, 2025 · Synced Sep 1, 2026, 2:40 PM EDT
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
37
States / cities
Homewood, Alabama • Palo Alto, California • Santa Barbara, California + 32 more
Source: ClinicalTrials.gov public record
Updated Aug 26, 2026 · Synced Sep 1, 2026, 2:40 PM EDT
Not yet recruiting Phase 1 Interventional

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

NCT07682649
View directory record Official record
Conditions
Metastatic Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Interventions
Biospecimen Collection, Computed Tomography, Gallium Ga 68 Gozetotide, Lutetium Lu 177 Vipivotide Tetraxetan, Positron Emission Tomography, Questionnaire Administration, Single Photon Emission Computed Tomography, Technetium Tc-99m Sulfur Colloid
Procedure · Other · Drug + 1 more
Lead sponsor
University of Michigan Rogel Cancer Center
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2031
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Jul 5, 2026 · Synced Sep 1, 2026, 2:40 PM EDT
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
106 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
5
States / cities
Los Angeles, California • Palo Alto, California • Rochester, Minnesota + 2 more
Source: ClinicalTrials.gov public record
Updated Dec 30, 2025 · Synced Sep 1, 2026, 2:40 PM 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 Aug 26, 2026 · Synced Sep 1, 2026, 2:40 PM 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 9, 2026 · Synced Sep 1, 2026, 2:40 PM EDT
Recruiting Phase 1Phase 2 Interventional

An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)

NCT07206056
View directory record Official record
Conditions
Progressive Metastatic Castrate Resistant Prostate Cancer
Interventions
Tulmimetostat DL1 QD, Tulmimetostat DL2 QD, Tulmimetostat DL3 QD, Tulmimetostat Doses 1 or 2 QD, Tulmimetostat RP2D QD, JSB462 Dose 1 QD, JSB462 Dose 2 QD, JSB462 QD, Standard of Care (SoC)
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older · Male only
Enrollment
188 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
8
States / cities
Denver, Colorado • Jacksonville, Florida • Atlanta, Georgia + 5 more
Source: ClinicalTrials.gov public record
Updated Aug 20, 2026 · Synced Sep 1, 2026, 2:40 PM EDT
Active, not recruiting Phase 2 Interventional

A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC

NCT05849298
View directory record Official record
Conditions
Prostatic Neoplasm
Interventions
AAA617, AAA517, Piflufolastat F 18, ARPI, ADT, Best supportive care
Drug · Other
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years · Male only
Enrollment
49 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
11
States / cities
Denver, Colorado • Athens, Georgia • Indianapolis, Indiana + 8 more
Source: ClinicalTrials.gov public record
Updated Jul 16, 2026 · Synced Sep 1, 2026, 2:40 PM 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 Aug 17, 2026 · Synced Sep 1, 2026, 2:40 PM EDT
Recruiting Phase 2 Interventional

Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial

NCT06288113
View directory record Official record
Conditions
Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Interventions
Biospecimen Collection, 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
Jonsson Comprehensive Cancer Center
Other
Eligibility
Male only
Enrollment
40 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 12, 2026 · Synced Sep 1, 2026, 2:40 PM 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 9, 2026 · Synced Sep 1, 2026, 2:40 PM EDT
Active, not recruiting Phase 3 Interventional

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

NCT04720157
View directory record Official record
Conditions
Prostatic Neoplasms
Interventions
177Lu-PSMA-617, 68Ga-PSMA-11, ARDT, ADT
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years · Male only
Enrollment
1,140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
70
States / cities
Scottsdale, Arizona • La Jolla, California • Los Angeles, California + 50 more
Source: ClinicalTrials.gov public record
Updated Jun 7, 2026 · Synced Sep 1, 2026, 2:40 PM 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 19, 2026 · Synced Sep 1, 2026, 2:40 PM EDT
Active, not recruiting Phase 2 Interventional

An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC

NCT06894511
View directory record Official record
Conditions
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Interventions
AAA617, ARPI: Abiraterone, ARPI: Enzalutamide
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years · Male only
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
5
States / cities
Casa Grande, Arizona • Gilbert, Arizona • Newport Beach, California + 2 more
Source: ClinicalTrials.gov public record
Updated Apr 30, 2026 · Synced Sep 1, 2026, 2:40 PM EDT
Recruiting Phase 3 Interventional

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

NCT05939414
View directory record Official record
Conditions
Oligometastatic Prostate Cancer (OMPC)
Interventions
AAA617, piflufolastat (18F), gallium (68Ga) gozetotide (25μg)
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years · Male only
Enrollment
450 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2031
U.S. locations
39
States / cities
Fayetteville, Arkansas • Los Angeles, California • Palo Alto, California + 30 more
Source: ClinicalTrials.gov public record
Updated Aug 31, 2026 · Synced Sep 1, 2026, 2:40 PM EDT
Recruiting Phase 2 Interventional

Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer

NCT06145633
View directory record Official record
Conditions
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
Interventions
Biopsy Procedure, Biospecimen Collection, Bone Scan, Computed Tomography, Fludeoxyglucose F-18, Gallium Ga 68 Gozetotide, Lutetium Lu 177 Vipivotide Tetraxetan, Positron Emission Tomography, Single Photon Emission Computed Tomography, Vorinostat
Procedure · Other · Drug
Lead sponsor
Fred Hutchinson Cancer Center
Other
Eligibility
Male only
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Aug 5, 2026 · Synced Sep 1, 2026, 2:40 PM 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
3
States / cities
Los Angeles, California • El Paso, Texas • Murray, Utah
Source: ClinicalTrials.gov public record
Updated Aug 17, 2026 · Synced Sep 1, 2026, 2:40 PM 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 19, 2026 · Synced Sep 1, 2026, 2:40 PM EDT