Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate vipivotide tetraxetan, predominantly targeting prostate cancer—including metastatic castration-resistant and hormone-sensitive subtypes—and select solid malignancies such as adenoid cystic carcinoma. Sponsored by major academic institutions like Dana-Farber Cancer Institute and UCSF alongside pharmaceutical companies such as Novartis and Janssen, these studies assess topics including combination therapies and biodistribution. Trial recruitment statuses across these investigations encompass actively recruiting, not yet recruiting, active not recruiting, completed, and withdrawn protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07200830 | RECRUITING | Metastatic Castration-Resistant Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IVB Prostate Cancer AJCC v8 |
Alliance for Clinical Trials in Oncology |
2026-03-31 | PHASE3 |
| NCT06600802 | RECRUITING | Castration-resistant Metastatic Prostate Cancer; Treated by 177Lutetium-PSMA-617 (Lu-PSMA) |
Centre Jean Perrin |
2024-10-08 | |
| NCT05803941 | RECRUITING | Prostate Cancer |
Novartis Pharmaceuticals |
2023-08-14 | PHASE4 |
| NCT06496581 | RECRUITING | Prostate Cancer Metastatic |
UNICANCER |
2024-09-12 | PHASE3 |
| NCT07550517 | NOT_YET_RECRUITING | High-Risk Localized Prostate Cancer |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2026-08 | PHASE2 |
| NCT06320067 | RECRUITING | Prostate Cancer Metastatic |
University College, London |
2024-06-11 | PHASE3 |
| NCT07650240 | NOT_YET_RECRUITING | 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 |
Mayo Clinic |
2026-07-01 | PHASE2 |
| NCT06449781 | RECRUITING | Prostate Cancer |
Maria Sklodowska-Curie National Research Institute of Oncology |
2025-01-09 | PHASE2 |
| NCT07150715 | RECRUITING | Oligometastatic Prostate Adenocarcinoma; Recurrent Prostate Adenocarcinoma |
Jonsson Comprehensive Cancer Center |
2025-12-12 | PHASE2 |
| NCT07737925 | NOT_YET_RECRUITING | Prostate Cancer; Metastatic Castrate Resistant Prostate Cancer |
Thomas Jefferson University |
2026-10 | PHASE2 |
| NCT06632977 | RECRUITING | Castration-Resistant Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8 |
Alliance for Clinical Trials in Oncology |
2025-02-06 | PHASE2 |
| NCT06200103 | SUSPENDED | Castration-Resistant Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8 |
Mayo Clinic |
2024-05-03 | PHASE2 |
| NCT07698535 | RECRUITING | Metastatic Castration-Resistant Prostate Adenocarcinoma; Stage IVB Prostate Cancer AJCC v8 |
University of Washington |
2026-10-01 | PHASE2 |
| NCT06943495 | RECRUITING | Metastatic Castrate Resistant Prostate Cancer (mCRPC) |
Jean-Mathieu Beauregard |
2025-08-15 | PHASE1 |
| NCT06798558 | RECRUITING | Prostate Adenocarcinoma |
Hackensack Meridian Health |
2025-03-05 | PHASE2 |
| NCT06531499 | RECRUITING | Metastatic Castration-Resistant Prostate Cancer |
Novartis Pharmaceuticals |
2024-11-11 | PHASE1 |
| NCT07145177 | RECRUITING | Metastatic Prostate Cancer; Prostate Cancer |
University of California, San Francisco |
2026-03-16 | PHASE1 |
| NCT06039371 | RECRUITING | Castration-Resistant Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IVB Prostate Cancer AJCC v8 |
University of Washington |
2024-05-21 | PHASE2 |
| NCT07587814 | NOT_YET_RECRUITING | Carcinoma; Castration Resistant Prostatic Neoplasms |
Centre Henri Becquerel |
2026-09 | |
| NCT07219147 | RECRUITING | Metastatic Castration-Resistant Prostate Adenocarcinoma; Stage IVB Prostate Cancer AJCC v8 |
City of Hope Medical Center |
2026-03-06 | PHASE1 |
| NCT07226986 | RECRUITING | PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy |
Novartis Pharmaceuticals |
2025-12-05 | PHASE1; PHASE2 |
| NCT05939414 | RECRUITING | Oligometastatic Prostate Cancer (OMPC) |
Novartis Pharmaceuticals |
2024-03-12 | PHASE3 |
| NCT06959433 | NOT_YET_RECRUITING | Metastatic Renal Cancer |
Ankara University |
2026-05-01 | PHASE3 |
| NCT06783348 | RECRUITING | Metastatic Clear Cell Renal Cell Carcinoma |
European Organisation for Research and Treatment of Cancer - EORTC |
2026-04-07 | PHASE2 |
| NCT06216249 | RECRUITING | Prostate Carcinoma; Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8 |
Jonsson Comprehensive Cancer Center |
2024-08-01 | PHASE2 |
| NCT06526299 | RECRUITING | Metastatic Castration-Resistant Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8 |
University of Washington |
2025-04-29 | PHASE2 |
| NCT04886986 | RECRUITING | Prostate Cancer |
Weill Medical College of Cornell University |
2021-06-30 | PHASE1 |
| NCT06706921 | RECRUITING | Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant; Metastatic Prostate Cancer; Male Urogenital Diseases; Prostatic Diseases; Urogenital Diseases, Male; Genital Diseases, Male; Neoplasms; Neoplasms by Site; Urogenital Neoplasms; Genital Neoplasms, Male |
VA Greater Los Angeles Healthcare System |
2024-12-15 | PHASE4 |
| NCT06199453 | WITHDRAWN | Adenoid Cystic Carcinoma |
Maria Sklodowska-Curie National Research Institute of Oncology |
2024-01 | PHASE2 |
| NCT07223034 | RECRUITING | 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 |
Memorial Sloan Kettering Cancer Center |
2025-10-27 | PHASE1 |
| NCT05079698 | ACTIVE_NOT_RECRUITING | Prostate Cancer |
Memorial Sloan Kettering Cancer Center |
2021-10-01 | PHASE1 |
| NCT07476001 | RECRUITING | Metastatic Castration-resistant Prostate Cancer |
H. Lee Moffitt Cancer Center and Research Institute |
2026-03-03 | PHASE2 |
| NCT05818683 | RECRUITING | Metastatic Castration-resistant Prostate Neoplasms; Metastatic Hormone-sensitive Prostate Cancer |
Janssen Research & Development, LLC |
2023-04-26 | PHASE1 |
| NCT07682649 | NOT_YET_RECRUITING | Metastatic Castration-Resistant Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8 |
University of Michigan Rogel Cancer Center |
2026-08-01 | PHASE1 |
| NCT07047118 | ACTIVE_NOT_RECRUITING | Prostatic Cancer, Castration-Resistant |
Novartis Pharmaceuticals |
2025-07-03 | PHASE2 |
| NCT07677566 | NOT_YET_RECRUITING | Prostate Cancer; Prostate Cancer Patients |
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
2026-07-01 | PHASE4 |
| NCT06095089 | RECRUITING | Prostatic Neoplasms |
Janssen Research & Development, LLC |
2023-11-01 | PHASE1 |
| NCT05766371 | RECRUITING | Castrate Resistant Prostate Cancer; Metastatic Castration-resistant Prostate Cancer; Prostate Cancer; Prostate Carcinoma |
University of California, San Francisco |
2023-12-15 | PHASE2 |
| NCT05113537 | RECRUITING | 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 |
Vadim S Koshkin |
2022-07-08 | PHASE1; PHASE2 |
| NCT07054346 | RECRUITING | Prostate Cancer; Prostate Cancer (Diagnosis); High-risk Prostate Cancer; Localized Prostate Carcinoma; Very High Risk Prostate Carcinoma |
Thomas Hope |
2025-07-08 | PHASE1 |
| NCT06972628 | RECRUITING | Metastatic Castration-Resistant Prostate Cancer; Prostate Cancer Patients With Bone Metastasis; Prostate Cancer (CRPC); Prostate Cancer; Prostate Cancer Metastatic |
Ebrahim S Delpassand |
2025-05-23 | PHASE2 |
| NCT06866938 | RECRUITING | Metastatic Castration-resistant Prostate Cancer |
Hospices Civils de Lyon |
2025-04-11 | PHASE2 |
| NCT06136377 | NOT_YET_RECRUITING | Patients With Metastatic Castration-resistant Prostate Cancer |
Centre Georges Francois Leclerc |
2024-01-31 | |
| NCT06288113 | RECRUITING | Castration-Resistant Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8 |
Jonsson Comprehensive Cancer Center |
2024-08-01 | PHASE2 |
| NCT04597411 | ACTIVE_NOT_RECRUITING | Prostatic Neoplasms, Castration-Resistant |
Endocyte |
2021-04-01 | PHASE1 |
| NCT07639801 | NOT_YET_RECRUITING | Prostate Cancer; Hepatocellular Carcinoma; Ovarian Cancer; Solid Tumors; Endometrial Cancer; FAPI; PSMA |
Peking University Cancer Hospital & Institute |
2026-06 | |
| NCT06145633 | RECRUITING | Castration-Resistant Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IVB Prostate Cancer AJCC v8 |
Fred Hutchinson Cancer Center |
2024-09-18 | PHASE2 |
| NCT05849298 | ACTIVE_NOT_RECRUITING | Prostatic Neoplasm |
Novartis Pharmaceuticals |
2024-01-03 | PHASE2 |
| NCT06004661 | ACTIVE_NOT_RECRUITING | Metastatic Castration-Resistant Prostate Cancer (mCRPC) |
Novartis Pharmaceuticals |
2024-04-04 | PHASE2 |
| NCT06099093 | RECRUITING | Prostate Cancer; Metastatic Castration-resistant Prostate Cancer; Metastatic Castration-resistant Prostate Carcinoma |
Brigham and Women's Hospital |
2024-04-01 | PHASE4 |
| NCT06964958 | ACTIVE_NOT_RECRUITING | Renal Cell Carcinoma; Advanced Clear Cell Renal Cell Carcinoma; Kidney Cancer |
Dana-Farber Cancer Institute |
2025-07-31 | PHASE2 |
| NCT06852820 | RECRUITING | Liver Cancer; Hepatocellular Carcinoma; Metastatic Liver Cancer |
Melissa Lumish |
2026-06 | PHASE2 |
| NCT05613894 | RECRUITING | Metastatic Castration-resistant Prostate Cancer |
University of Utah |
2023-07-14 | PHASE1 |
| NCT06738303 | RECRUITING | Metastatic Prostate Cancer; Metastatic Castration-resistant Prostate Cancer |
Case Comprehensive Cancer Center |
2025-07-14 | PHASE2 |
| NCT06568562 | RECRUITING | Metastatic Castration-resistant Prostate Cancer |
University of Utah |
2024-12-09 | PHASE2 |
| NCT05682443 | ACTIVE_NOT_RECRUITING | Metastatic Castration-resistant Prostate Cancer |
OncoC4, Inc. |
2023-12-11 | PHASE1; PHASE2 |
| NCT06303713 | ACTIVE_NOT_RECRUITING | Prostate Cancer; Metastatic Prostate Cancer; Metastatic Castration-resistant Prostate Cancer |
Dana-Farber Cancer Institute |
2024-05-22 | PHASE1 |
| NCT06894511 | ACTIVE_NOT_RECRUITING | Metastatic Castration Resistant Prostate Cancer (mCRPC) |
Novartis Pharmaceuticals |
2025-09-11 | PHASE2 |
| NCT06329830 | WITHDRAWN | Metastatic Prostate Cancer; Castration-resistant Prostate Cancer; Metastatic Castration-resistant Prostate Cancer |
Baptist Health South Florida |
2024-10 | PHASE1; PHASE2 |
| NCT06574880 | RECRUITING | Malignant Neoplasm of Prostate; Locally Advanced Prostate Cancer |
Angela Y. Jia, MD PhD |
2025-05-13 | PHASE1; PHASE2 |
| NCT06379217 | ACTIVE_NOT_RECRUITING | Metastatic Neuroendocrine Prostate Cancer |
Novartis Pharmaceuticals |
2024-07-29 | PHASE1 |
| NCT05340374 | ACTIVE_NOT_RECRUITING | Metastatic Castration-resistant Prostate Cancer; mCRPC |
Peter MacCallum Cancer Centre, Australia |
2022-07-14 | PHASE1; PHASE2 |
| NCT07025512 | WITHDRAWN | Metastatic Castration Resistant Prostate Cancer; Cytopenia; Anemia; Thrombocytopenia |
M.D. Anderson Cancer Center |
2025-08-03 | PHASE2 |
| NCT06388369 | TERMINATED | Very High Risk Prostate Carcinoma |
University Hospital, Essen |
2025-08-25 | PHASE1; PHASE2 |
| NCT04343885 | ACTIVE_NOT_RECRUITING | Metastatic Hormone Naive Prostate Cancer |
Peter MacCallum Cancer Centre, Australia |
2020-04-21 | PHASE2 |
| NCT05162573 | COMPLETED | Prostatic Neoplasm |
The Netherlands Cancer Institute |
2021-12-20 | PHASE1 |
| NCT04663997 | ACTIVE_NOT_RECRUITING | Prostate Cancer |
Canadian Cancer Trials Group |
2021-08-11 | PHASE2 |
| NCT06516510 | TERMINATED | Metastatic Prostate Cancer |
Blue Earth Therapeutics Ltd |
2024-10-31 | EARLY_PHASE1 |
| NCT03874884 | ACTIVE_NOT_RECRUITING | Metastatic Castration Resistant Prostate Cancer (mCRPC) |
Peter MacCallum Cancer Centre, Australia |
2019-07-09 | PHASE1 |
| NCT05633160 | TERMINATED | Prostatic Neoplasms; Castration-Resistant |
Clarity Pharmaceuticals Ltd |
2023-06-15 | PHASE1; PHASE2 |
| NCT04443062 | COMPLETED | Prostate Cancer |
Radboud University Medical Center |
2020-07-20 | PHASE2 |
| NCT04720157 | ACTIVE_NOT_RECRUITING | Prostatic Neoplasms |
Novartis Pharmaceuticals |
2021-06-09 | PHASE3 |
| NCT05658003 | ACTIVE_NOT_RECRUITING | Metastatic Castration-Resistant Prostate Cancer (mCRPC) |
Novartis Pharmaceuticals |
2023-05-05 | PHASE2 |
| NCT05150236 | UNKNOWN | Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Prostate Cancer; Neoplasms by Site; Neoplasms; Prostatic Disease |
Australian and New Zealand Urogenital and Prostate Cancer Trials Group |
2022-04-29 | PHASE2 |
| NCT06437496 | UNKNOWN | Malignant Neoplasm of Prostate |
First Affiliated Hospital of Fujian Medical University |
2024-04-01 | EARLY_PHASE1 |
| NCT03454750 | COMPLETED | Metastatic Castration Resistant Prostate Cancer; 68Ga-PSMA PET/CT Positive |
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS |
2022-10-25 | PHASE2 |
| NCT05670106 | COMPLETED | Metastatic Castration-Resistant Prostate Cancer (mCRPC) |
Novartis Pharmaceuticals |
2023-05-16 | PHASE2 |
| NCT06303713 | Not yet recruiting | Prostate Cancer|Metastatic Prostate Cancer|Metastatic Castration-resistant Prostate Cancer |
Dana-Farber Cancer Institute|Novartis |
2024-05 | Phase 1 |
| NCT06004661 | Recruiting | Metastatic Castration-Resistant Prostate Cancer (mCRPC) |
Novartis Pharmaceuticals|Novartis |
2024-04-04 | Phase 2 |
| NCT03805594 | COMPLETED | Castration Levels of Testosterone; Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Prostate Adenocarcinoma; Stage IV Prostate Cancer; Stage IVA Prostate Cancer; Stage IVB Prostate Cancer |
University of California, San Francisco |
2019-05-10 | PHASE1 |
| NCT05547386 | COMPLETED | Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8 |
Mayo Clinic |
2022-05-09 | PHASE3 |
| NCT05114746 | COMPLETED | Prostate Cancer |
Novartis Pharmaceuticals |
2022-01-25 | PHASE2 |
| NCT05766371 | Recruiting | Castrate Resistant Prostate Cancer|Metastatic Castration-resistant Prostate Cancer|Prostate Cancer|Prostate Carcinoma |
University of California San Francisco|Merck Sharp & Dohme LLC|Prostate Cancer Foundation |
2023-12-15 | Phase 2 |
| NCT03606837 | COMPLETED | Prostate Cancer |
University Hospital, Bordeaux |
2019-07-11 | PHASE2 |
| NCT05841992 | UNKNOWN | Prostate Cancer |
Peking Union Medical College Hospital |
2021-07-01 | PHASE2; PHASE3 |
| NCT04430192 | ACTIVE_NOT_RECRUITING | Prostatic Neoplasms |
Peter MacCallum Cancer Centre, Australia |
2020-08-06 | PHASE1; PHASE2 |
| NCT03658447 | COMPLETED | Metastatic Castration Resistant Prostate Cancer |
Peter MacCallum Cancer Centre, Australia |
2019-07-12 | PHASE1; PHASE2 |
| NCT04689828 | ACTIVE_NOT_RECRUITING | Prostatic Neoplasms |
Novartis Pharmaceuticals |
2021-06-15 | PHASE3 |
| NCT05170555 | UNKNOWN | Renal Cell Carcinoma |
Peking Union Medical College Hospital |
2021-12-01 | |
| NCT04801264 | UNKNOWN | Adenoid Cystic Carcinoma |
Peking Union Medical College Hospital |
2020-09-01 | EARLY_PHASE1 |
| NCT05228106 | Recruiting | Solid Cancers |
Centre de recherche du Centre hospitalier universitaire de Sherbrooke |
2022-01-21 | -- |
| NCT03042468 | ACTIVE_NOT_RECRUITING | Prostate Cancer |
Weill Medical College of Cornell University |
2016-12 | PHASE1; PHASE2 |
| NCT04796467 | UNKNOWN | Prostate Cancer |
Peking Union Medical College Hospital |
2020-10-01 | PHASE2; PHASE3 |
| NCT03511664 | COMPLETED | Prostate Cancer |
Endocyte |
2018-05-29 | PHASE3 |
| NCT03780075 | UNKNOWN | Metastatic Castration-resistant Prostate Cancer |
Peking Union Medical College Hospital |
2018-04-15 | PHASE1 |
| NCT03545165 | TERMINATED | Prostate Cancer |
Weill Medical College of Cornell University |
2018-04-18 | PHASE1; PHASE2 |
| NCT03042312 | TERMINATED | Metastatic Castration Resistant Prostate Cancer |
Endocyte |
2017-07-12 | PHASE2 |
| NCT03392428 | COMPLETED | Cancer of the Prostate; Metastatic Cancer |
Australian and New Zealand Urogenital and Prostate Cancer Trials Group |
2018-01-29 | PHASE2 |
| NCT03604757 | COMPLETED | Prostate Cancer |
University Hospital, Bordeaux |
2018-04-25 | PHASE2 |
| NCT03828838 | COMPLETED | Prostate Neoplasm |
Radboud University Medical Center |
2018-07-01 | PHASE1; PHASE2 |
| NCT03403595 | UNKNOWN | Metastatic Castration-resistant Prostate Cancer |
Peking Union Medical College Hospital |
2017-12-01 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-09-02)
Check the
Vipivotide tetraxetan (PSMA-617)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Vipivotide tetraxetan (PSMA-617) Solubility in DMSO
- Vipivotide tetraxetan (PSMA-617) Stock Solution
- Vipivotide tetraxetan (PSMA-617) Storage
- Vipivotide tetraxetan (PSMA-617) Stability
- Vipivotide tetraxetan (PSMA-617) Molecular Weight
- Vipivotide tetraxetan (PSMA-617) SMILES
- Vipivotide tetraxetan (PSMA-617) CAS Number
- Vipivotide tetraxetan (PSMA-617) Chemical Structure (2D and 3D)
- Vipivotide tetraxetan (PSMA-617) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.