Lutetium Lu 177 Vipivotide Tetraxetan

DRUG13 trials

Sponsors

OncoC4, Inc., Fred Hutchinson Cancer Center, Mayo Clinic, Jonsson Comprehensive Cancer Center, University of Washington

Conditions

Adenocarcinoma of the ProstateAdvanced Prostate AdenocarcinomaAdvanced Prostate CancerCastration-Resistant Prostate CarcinomaCastration-Sensitive Prostate CancerLocalized Prostate CarcinomaMetastatic Castration-Resistant Prostate AdenocarcinomaMetastatic Castration-Resistant Prostate Carcinoma

Phase 1

ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC

Active, not recruitingNCT05682443

OncoC4, Inc.Metastatic Castration-resistant Prostate Cancer

Start: 2023-12-11End: 2027-11-30Updated: 2026-05-22

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

RecruitingNCT07219147

City of Hope Medical CenterMetastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8

Start: 2026-03-06End: 2028-07-26Target: 30Updated: 2026-04-20

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

Not yet recruitingNCT07682649

University of Michigan Rogel Cancer CenterMetastatic Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8

Start: 2026-08-01End: 2031-08-01Target: 20Updated: 2026-07-06

Phase 2

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

RecruitingNCT06145633

Fred Hutchinson Cancer CenterCastration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8

Start: 2024-09-18End: 2027-12-30Target: 15Updated: 2026-01-28

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

RecruitingNCT06200103

Mayo ClinicCastration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8

Start: 2024-05-03End: 2029-12-31Target: 236Updated: 2025-09-11

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

RecruitingNCT06216249

Jonsson Comprehensive Cancer CenterProstate Carcinoma, Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8

Start: 2024-08-01End: 2028-12-31Target: 90Updated: 2026-03-10

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

RecruitingNCT06288113

Jonsson Comprehensive Cancer CenterCastration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8

Start: 2024-08-01End: 2028-01-27Target: 40Updated: 2026-03-13

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

RecruitingNCT06526299

University of WashingtonMetastatic Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8

Start: 2025-04-29End: 2027-12-31Target: 51Updated: 2026-07-07

Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial

RecruitingNCT06632977

Alliance for Clinical Trials in OncologyCastration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8

Start: 2025-02-06End: 2034-10-11Target: 474Updated: 2026-06-02

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

RecruitingNCT07150715

Jonsson Comprehensive Cancer CenterOligometastatic Prostate Adenocarcinoma, Recurrent Prostate Adenocarcinoma

Start: 2025-12-12End: 2031-10-31Target: 107Updated: 2025-12-17

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

Not yet recruitingNCT07650240

Mayo ClinicAdenocarcinoma of the Prostate, Advanced Prostate Adenocarcinoma, Advanced Prostate Cancer +9

Start: 2026-07-01End: 2030-12-30Target: 202Updated: 2026-06-17

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

Not yet recruitingNCT07698535

University of WashingtonMetastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8

Start: 2026-12-01End: 2029-07-05Target: 64Updated: 2026-07-17

Phase 3

Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial

RecruitingNCT07200830

Alliance for Clinical Trials in OncologyMetastatic Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8

Start: 2026-03-31End: 2034-09-09Target: 1524Updated: 2026-07-02

Related Papers

Alpha-emitting radionuclide or beta-emitting radionuclide combined with metastasis-directed stereotactic body radiotherapy for oligorecurrent prostate adenocarcinoma (ANDROMEDA): A phase II trial.

Journal of Clinical Oncology2026-05-28

Predicting response to <sup>177</sup> Lu-PSMA-617 in metastatic prostate cancer (mPC) using plasma-derived extracellular vesicles (EVs).

Journal of Clinical Oncology2026-05-27

Clinical Utility of Transcriptomic Signatures to Identify Androgen Receptor and Neuroendocrine Signaling in Prostate Cancer.

2026-03-05

VALOR study: A phase II trial of vorinostat to augment response to 177Lutetium-PSMA-617 in the treatment of patients with PSMA-low metastatic castration resistant prostate cancer.

Journal of Clinical Oncology2025-05-281 citations

Study protocol: Phase 2 trial of re-treatment with 177Lu-PSMA-617 molecular radiotherapy for metastatic castration resistant prostate cancer (RE-LuPSMA trial).

Journal of Clinical Oncology2025-05-28

A randomized phase 2 trial of flexible and extended dosing of <sup>177</sup> Lu-PSMA-617 molecular radioligand therapy in mCRPC (FLEX-MRT): Trial in progress update.

Journal of Clinical Oncology2025-05-28

Precision diagnostics in prostate cancer treatment (PREDICT): A phase 2 multi-arm biomarker based study (Alliance A032102).

Journal of Clinical Oncology2025-05-28

Phase 1 study of gotistobart (BNT316/ONC-392) in combination with lutetium Lu 177 vipivotide tetraxetan (Lu 177) in patients with metastatic castration-resistant prostate cancer (mCRPC).

Journal of Clinical Oncology2025-05-28

A randomized phase 2 trial in progress of flexible and extended dosing of <sup>177</sup>Lu-PSMA-617 molecular radioligand therapy in mCRPC (FLEX-MRT).

Journal of Clinical Oncology2024-06-011 citations