Lutetium Lu 177 Vipivotide Tetraxetan

DRUG10 trials

Sponsors

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

Conditions

Castration-Resistant Prostate CarcinomaMetastatic Castration-Resistant Prostate AdenocarcinomaMetastatic Castration-Resistant Prostate CarcinomaMetastatic Castration-resistant Prostate CancerMetastatic Prostate AdenocarcinomaOligometastatic Prostate AdenocarcinomaProstate CarcinomaRecurrent Prostate Adenocarcinoma

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: 2027-06-30Updated: 2025-12-02

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: 2026-03-05End: 2028-07-26Target: 30Updated: 2026-01-28

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: 2026-03-24

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: 2026-03-04

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

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

Not yet recruitingNCT07200830

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

Start: 2025-10-08End: 2034-09-09Target: 1524Updated: 2025-10-01

Related Papers

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