^
    2d
    Study of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer (clinicaltrials.gov)
    P1/2, N=32, Recruiting, Sinotau Pharmaceutical Group | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    2d
    Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer in Japan (clinicaltrials.gov)
    P2, N=80, Recruiting, Novartis Pharmaceuticals | Active, not recruiting --> Recruiting | N=30 --> 80 | Trial primary completion date: Apr 2026 --> Dec 2023
    Enrollment open • Enrollment change • Trial primary completion date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3d
    TNB585.001: A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov)
    P1, N=42, Active, not recruiting, Amgen | N=100 --> 42
    Enrollment change • Metastases
    3d
    PROQURE-1: EBRT + Lu-PSMA for N1M0 Prostate Cancer (clinicaltrials.gov)
    P1, N=24, Recruiting, The Netherlands Cancer Institute | N=18 --> 24 | Trial completion date: Dec 2023 --> Jul 2025 | Trial primary completion date: Sep 2023 --> Jul 2025
    Enrollment change • Trial completion date • Trial primary completion date
    |
    FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3d
    External Beam Therapy With Theranostic Radioligand Therapy for Oligometastatic Prostate Cancer (ProstACT TARGET) (clinicaltrials.gov)
    P2, N=5, Active, not recruiting, Telix Pharmaceuticals (Innovations) Pty Limited | Recruiting --> Active, not recruiting | N=50 --> 5 | Trial completion date: Jun 2025 --> Aug 2024
    Enrollment closed • Enrollment change • Trial completion date • Combination therapy • Metastases
    |
    177Lu-rosopatamab tetraxetan (TLX591)
    4d
    Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Jonsson Comprehensive Cancer Center | Initiation date: Apr 2024 --> Jun 2024
    Trial initiation date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    6d
    (SEEtoTREAT): SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization (clinicaltrials.gov)
    P=N/A, N=80, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    New trial
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • Xofigo (radium Ra-223 dichloride)
    6d
    INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma (clinicaltrials.gov)
    P1/2, N=35, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Tecentriq (atezolizumab) • INO-5401 • rocakinogene sifuplasmid (INO-9012)
    6d
    LUCIDA_2: [Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application_2 (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, FutureChem | Recruiting --> Active, not recruiting | Trial completion date: May 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Dec 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    [177Lu]ludotadipep (177 Lu-FC705)
    6d
    LUCIDA: [Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application (clinicaltrials.gov)
    P1/2, N=26, Recruiting, FutureChem | Phase classification: P2a --> P1/2 | Trial completion date: Aug 2024 --> Jun 2025 | Trial primary completion date: Aug 2024 --> Jun 2025
    Phase classification • Trial completion date • Trial primary completion date • Metastases
    |
    FOLH1 positive
    |
    [177Lu]ludotadipep (177 Lu-FC705)
    8d
    Human ABC and SLC Transporters: The Culprit Responsible for Unspecific PSMA-617 Uptake? (PubMed, Pharmaceuticals (Basel))
    Our results indicate that [177Lu]Lu-PSMA-617 and [225Ac]Ac-PSMA-617 are neither inhibitors nor substrates of the examined transporters. Therefore, our results show that human ABC and SLC transporters play no central role in the uptake and retention of [177Lu]Lu-PSMA-617 and [225Ac]Ac-PSMA-617 in the SGs and kidneys nor in the observed toxicities.
    Journal
    |
    ABCB1 (ATP Binding Cassette Subfamily B Member 1)
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    9d
    Exploring the role of combined external beam radiotherapy and targeted radioligand therapy with [177Lu]Lu-PSMA-617 for prostate cancer - from bench to bedside. (PubMed, Theranostics)
    The present preclinical and clinical data demonstrate that the combination of EBRT with dose escalation by PSMA-RLT improves tumor control and potentially prolongs survival. This may pave the way for further clinical investigations of this approach to explore the curative potential of the combination therapy.
    Journal
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression • FOLH1 overexpression
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    10d
    Genomic Correlates of Prostate-Specific Membrane Antigen Expression and Response to 177Lu-PSMA-617: A Retrospective Multicenter Cohort Study. (PubMed, JCO Precis Oncol)
    Outcomes on LuPSMA varied on the basis of mutational profile. Prospective studies to define the clinical activity of LuPSMA in predefined genomic subgroups are justified.
    Retrospective data • Journal
    |
    TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • ATM (ATM serine/threonine kinase) • RB1 (RB Transcriptional Corepressor 1)
    |
    TP53 mutation • ATM mutation • PTEN mutation • RB1 mutation
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    12d
    ACCEL: [Ac-225]-PSMA-62 Trial in Biochemically Recurrent and Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=48, Recruiting, POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    12d
    NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (clinicaltrials.gov)
    P1, N=36, Not yet recruiting, Novartis Pharmaceuticals
    New P1 trial • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • AAA603
    13d
    Clinical Evaluation of 177Lu-DansyI-PSMA (LNC1011) in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=20, Recruiting, The First Affiliated Hospital of Xiamen University
    New P1 trial • Metastases
    23d
    PSMA Therapy and Immunotherapy in Kidney Cancer (clinicaltrials.gov)
    P1/2, N=37, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    New P1/2 trial • Metastases
    |
    Keytruda (pembrolizumab) • PNT2002
    24d
    177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study (clinicaltrials.gov)
    P2, N=93, Active, not recruiting, Jonsson Comprehensive Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    PNT2002
    27d
    Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=15, Not yet recruiting, University of Washington | Initiation date: Apr 2024 --> Aug 2024
    Trial initiation date • Metastases
    |
    Zolinza (vorinostat) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    1m
    Targeted interleukin-2 enhances the in vivo anti-cancer activity of Pluvicto™. (PubMed, Eur J Nucl Med Mol Imaging)
    The therapeutic efficacy of Pluvicto™ at low radioactive doses can be effectively enhanced by the combination with L19-IL2. Our findings warrant further clinical exploration of this novel combination modality.
    Preclinical • Journal
    |
    IL2 (Interleukin 2)
    |
    FOLH1 expression
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    1m
    NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial (clinicaltrials.gov)
    P1/2, N=36, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    Firmagon (degarelix)
    1m
    PAnTHA: First-in-human Study of 225Ac-PSMA-Trillium (BAY 3563254) in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
    P1, N=118, Recruiting, Bayer | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    1m
    A Comparison of 68Ga-PSMA PET/CT-Based Split Renal Function with 99mTc-MAG3 Renography in Patients with Metastatic Castration-Resistant Prostate Carcinoma Treated with 177Lu-PSMA. (PubMed, Diagnostics (Basel))
    PSMA-derived split function demonstrated a high correlation with renal function assessed on diuretic 99mTc-MAG3 renograms. PET-derived split renal function may, therefore, be considered an alternative to diuretic renogram-based split function. Furthermore, both 99mTc-MAG3 and 68Ga-PSMA PET/CT studies identified morphological renal abnormalities such as hydronephrosis, shrunken and obstructed kidneys. This correlation underscores the potential utility of 68Ga-PSMA imaging as a valuable tool for assessing kidney morphology as an alternative to renogram split function in clinical practice.
    Journal • Metastases
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression • FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    1m
    64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study) (clinicaltrials.gov)
    P1, N=14, Completed, Telix International Pty Ltd | Recruiting --> Completed | Trial completion date: Apr 2023 --> Jan 2024 | Trial primary completion date: Apr 2023 --> Dec 2023
    Trial completion • Trial completion date • Trial primary completion date
    |
    FOLH1 expression
    1m
    A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC (clinicaltrials.gov)
    P2, N=62, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | Trial completion date: Aug 2025 --> Oct 2026 | Trial primary completion date: Apr 2024 --> Jan 2026
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    1m
    Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=136, Not yet recruiting, Mayo Clinic | Phase classification: P4 --> P2
    Phase classification • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    2ms
    177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma (clinicaltrials.gov)
    P2, N=10, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    New P2 trial
    |
    PNT2002
    2ms
    VIOLET: EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T (clinicaltrials.gov)
    P1/2, N=30, Active, not recruiting, Peter MacCallum Cancer Centre, Australia | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    AR (Androgen receptor)
    2ms
    AB-2100, an Integrated Circuit T (ICT) Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC) (clinicaltrials.gov)
    P1/2, N=130, Recruiting, Arsenal Biosciences, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    cyclophosphamide • AB-2100
    2ms
    PSMA-DC: An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. (clinicaltrials.gov)
    P3, N=450, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    FOLH1 positive
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    2ms
    LuCarbo - a Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=37, Not yet recruiting, Dana-Farber Cancer Institute
    New P1 trial • Metastases
    |
    carboplatin • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    2ms
    Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Jonsson Comprehensive Cancer Center
    New P2 trial
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    2ms
    177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P3, N=439, Active, not recruiting, Curium US LLC | Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2024 --> Jul 2024
    Enrollment closed • Trial primary completion date • Metastases
    |
    Xtandi (enzalutamide capsule) • abiraterone acetate
    2ms
    CBT307-1: A Phase I Study to Assess PSMA+ and PSMA- Tumour Lesions (clinicaltrials.gov)
    P1, N=5, Active, not recruiting, Crescendo Biologics Ltd. | Recruiting --> Active, not recruiting | N=12 --> 5 | Trial completion date: Dec 2023 --> Oct 2024
    Enrollment closed • Enrollment change • Trial completion date
    |
    CB307
    2ms
    A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC (clinicaltrials.gov)
    P2, N=60, Recruiting, Novartis Pharmaceuticals | Trial completion date: Oct 2026 --> Aug 2025 | Trial primary completion date: May 2026 --> Apr 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3ms
    Evaluation of a Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Jonsson Comprehensive Cancer Center | Initiation date: Feb 2024 --> Jul 2024
    Trial initiation date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3ms
    HPN424-1001: Study of HPN424 in Patients With Advanced Prostate Cancer (clinicaltrials.gov)
    P1/2, N=104, Terminated, Harpoon Therapeutics | Active, not recruiting --> Terminated; Decision not to continue to the expansion portion of the study
    Trial termination • Metastases
    |
    HPN424
    3ms
    A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=60, Recruiting, Novartis Pharmaceuticals | Trial completion date: Apr 2028 --> Jan 2027 | Trial primary completion date: Feb 2026 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3ms
    PSMAfore: 177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer (clinicaltrials.gov)
    P3, N=469, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jan 2025 --> Sep 2025
    Trial completion date • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3ms
    ENZA-p: Enzalutamide With Lu PSMA-617 Versus Enzalutamide Alone in Men With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=162, Active, not recruiting, Australian and New Zealand Urogenital and Prostate Cancer Trials Group | Trial completion date: Jun 2024 --> Jan 2025 | Trial primary completion date: Dec 2023 --> Jul 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    Xtandi (enzalutamide capsule) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    3ms
    Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer (clinicaltrials.gov)
    P1, N=60, Recruiting, Endocyte | Trial completion date: Mar 2026 --> Jan 2027 | Trial primary completion date: Mar 2026 --> Jan 2027
    Trial completion date • Trial primary completion date
    |
    abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • AAA817
    3ms
    A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer (clinicaltrials.gov)
    P1/2, N=370, Recruiting, Regeneron Pharmaceuticals | N=199 --> 370 | Trial completion date: Aug 2026 --> Jan 2027 | Trial primary completion date: Aug 2026 --> Jan 2027
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Libtayo (cemiplimab-rwlc) • Kevzara (sarilumab) • nezastomig (REGN5678)